PART 84 - APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

(a) To establish procedures and prescribe requirements which must be met in filing applications for approval by the National Institute for Occupational Safety and Health of respirators or changes or modifications of approved respirators;

(b) To establish a schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part;

(c) To provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part; and

(d) To specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres.

Applicant means an individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator.

Approval means a certificate or formal document issued by the Institute stating that an individual respirator or combination of respirators has met the minimum requirements of this part, and that the applicant is authorized to use and attach an approval label to any respirator, respirator container, or instruction card for any respirator manufactured or assembled in conformance with the plans and specifications upon which the approval was based, as evidence of such approval.

Approved means conforming to the minimum requirements of this part.

Auxiliary equipment means a self-contained breathing apparatus, the use of which is limited in underground mine rescue and recovery operations to situations where the wearer has ready access to fresh air and at least one crew equipped with approved self-contained breathing apparatus of 2 hours or longer rating, is in reserve at a fresh-air base.

Compressed-breathing gas means oxygen or air stored in a compressed state and supplied to the wearer in gaseous form.

dBA means sound pressure levels in decibels, as measured with the A-weighted network of a standard sound level meter using slow response.

Dust means a solid mechanically produced particle with a size ranging from submicroscopic to macroscopic.

A facepiece or mouthpiece is a respirator component designed to provide a gas-tight or dust-tight fit with the face and may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas source.

Final inspection means that activity carried out on a product after all manufacturing and assembly operations are completed to insure completeness and adherence to performance or other specifications, including satisfactory appearance.

Fume means a solid condensation particle, generally less than 1 micrometer in diameter.

Gas means an aeriform fluid which is in a gaseous state at ordinary temperature and pressure.

Hazardous atmosphere means:

Immediately dangerous to life or health means conditions that pose an immediate threat to life or health or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive materials, which are likely to have adverse cumulative or delayed effects on health.

Incoming inspection means the activity of receiving, examining, and accepting only those materials and parts whose quality conforms to specification requirements.

In-process inspection means the control of products at the source of production and at each step of the manufacturing process, so that departures from specifications can be corrected before defective components or materials are assembled into the finished product.

Institute or NIOSH means the National Institute for Occupational Safety and Health, Department of Health and Human Services.

Liquefied-breathing gas means oxygen or air stored in liquid form and supplied to the wearer in a gaseous form.

Loose fitting means respiratory inlet covering that covers the wearer's head and neck, or head, neck, and shoulders, or whole body (when integral to the design).

Mist means a liquid condensation particle with a size ranging from submicroscopic to macroscopic.

MSHA means the Mine Safety and Health Administration, U.S. Department of Labor.

National Personal Protective Technology Laboratory (NPPTL) means the National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. NPPTL administers the NIOSH conformity assessment program for respiratory protective devices, replacing the former Certification and Quality Assurance Branch within the Division of Safety Research, Appalachian Laboratory for Occupational Safety and Health, NIOSH.

Not immediately dangerous to life or health means any hazardous atmosphere which may produce physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse physiological symptoms after prolonged exposure.

Oxygen-deficient atmosphere means an atmosphere which contains an oxygen partial pressure of less than 148 millimeters of mercury (19.5 percent by volume at sea level).

Powered air-purifying respirator means a device equipped with a facepiece, hood, or helmet, breathing tube, canister, cartridge, filter, canister with filter, or cartridge with filter, and a blower.

Respirator means any device designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere.

Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres.

Respirators for escape only means respiratory devices providing protection only during escape from hazardous atmospheres.

Respiratory inlet covering means that portion of a respirator that forms the protective barrier between the user's respiratory tract and an air-purifying device or breathing air source, or both.

(Single-use respirator means a respirator that is entirely discarded after excessive resistance, sorbent exhaustion, or physical damage renders it unsuitable for further use.

Tight fitting means a respiratory inlet covering that forms a complete gas tight or dust tight seal with the face or neck.

Vapor means the gaseous state of a substance that is solid or liquid at ordinary temperature and pressure.

Warning device is a component of a respiratory protective device that informs the wearer to take some action.

(a)

(b) NIOSH and MSHA shall jointly determine appropriate recall and retrofit remedies for field complaints or identified deficiencies involving any respirators used in the mining environment.

(a) Inspection, examination, and testing leading to the approval of the types of respirators classified in subpart F of this part shall be undertaken by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B.

(b) Applications must be submitted in accordance with the Standard Application Procedure for the Certification of Respirators under 42 CFR 84, (Standard Application Procedure) available on the NPPTL Web site, to Records Room, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(c) Except as provided in § 84.64, the examination, inspection, and testing of all respirators will be conducted or caused to be conducted by the National Personal Protective Technology Laboratory.

(d) Applicants, manufacturers, or their representatives may visit or communicate with the National Personal Protective Technology Laboratory in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge will be made for such consultation and no written report will be issued to applicants, manufacturers, or their representatives by the Institute as a result of such consultation.

(e) Respirators having electrical or electronic components that are required to be permissible under chapter I of title 30 shall be tested in accordance with 30 CFR part 18. Applications for approval of such respirators by MSHA shall be submitted in writing to: MSHA, Approval and Certification Center, Box 251, Industrial Park Road, Triadelphia, West Virginia 26059.

(a) Each application for approval shall contain a complete written description of the respirator for which approval is requested together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used.

(b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies.

(c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part.

(d) Each application shall contain a statement that the respirator has been pretested by the applicant as prescribed in § 84.64, and shall include the results of such tests.

(e) Each application for approval shall contain a statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.

(a) Each applicant shall, when an application is filed pursuant to § 84.10, be advised by the Institute of the total number of respirators and component parts required for testing.

(b) The applicant will deliver, at his or her own expense, the number of completely assembled respirators and component parts required for their examination, inspection, and testing, to the National Personal Protective Technology Laboratory.

(c) Respirators and component parts submitted for approval must be made from materials specified in the application.

(d) One completely assembled respirator approved under the provisions of this part may be retained by the Institute as a laboratory exhibit, the remaining respirators may be returned to the applicant at his own expense, upon written request within 30 days after notice of approval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.

(e) Where a respirator fails to meet the requirements for approval set forth in this part, all respirators and components delivered in accordance with this section may be returned to the applicant at his own expense, upon written request within 30 days after notice of disapproval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.

(a) This section establishes a system under which NIOSH charges a fee for services provided to applicants for conformity assessment activities conducted by NIOSH for respiratory protective devices under 42 CFR part 84. This section specifies the purposes for which fees will be assessed and the cost factors for such assessments.

(b) Fees will be charged for:

(c) Fees will not be charged for:

(a) This section explains the process NIOSH uses to calculate estimates of the direct and indirect costs of services provided in the course of application processing.

(b) Upon completion of an initial administrative review of the application, NIOSH will calculate a fee estimate for each application, including the maximum cost of conducting additional tests under § 84.24, and will provide that estimate, with payment details, to the applicant. The fee estimate will be derived using the current schedules of fees published by NIOSH in Part 84. NIOSH will begin the technical evaluation once the applicant accepts the terms of the fee estimate and authorizes payment.

(c) If NIOSH determines that actual costs for application processing and related testing will exceed the fee estimate provided to the applicant, NIOSH will provide a revised fee estimate for completing the application review before exceeding the previously-authorized fees. The applicant will have the option of either withdrawing the application and paying for services already performed or authorizing payment of the revised estimate, in which case NIOSH will continue the application review and testing.

(d) If the actual cost of processing the application is less than the fee estimate NIOSH provided to the applicant, NIOSH will charge the actual cost.

(e) If the applicant withdraws an application, the applicant will be invoiced for services already performed by NIOSH. Withdrawal of an application will be effective on the first business day following the date NIOSH receives a withdrawal notice from the applicant in writing. Withdrawal notices will be submitted to NIOSH in accordance with the Standard Application Procedure using the address specified in § 84.10.

(a) Applicants will be invoiced for all fees incurred in the processing of an application when all required reviews, analyses, evaluations, and tests are completed or the application is withdrawn. Invoices will contain specific payment instructions and identify authorized methods of payment.

(b) Applicants who hold active and/or obsolete certificates of approval will be invoiced by NIOSH annually for applicable maintenance fees, in accordance with the fee schedule published in Appendix A of this part.

(c) NIOSH reserves the right to impose sanctions for any missed payment, and will administer such penalties after assessing the circumstances of the manufacturer and the needs of other stakeholders. Sanctions may include but are not limited to:

(a) Each fee schedule will remain in effect for at least 2 years and will be revised as needed to reflect cost increases identified in biennial reviews.

(b) Fee schedule updates will be proposed in a notice of proposed rulemaking published in the Federal Register.

(c) The current fee schedules will be published in Appendix A and Appendix B of this part and will remain in effect until the effective date of the new fee schedules published in the Federal Register.

(a) The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators which have been examined, inspected, and tested, and which meet the minimum requirements set forth in subparts H through L of this part, as applicable.

(b) The Institute will not issue certificates of approval for any respirator component or for any respirator subassembly.

(c) The Institute shall not issue an informal notification of approval. However, if the application for approval, submitted in accordance with § 84.11, states that the submitted respirator and component parts are only prototypes, the Institute will examine, inspect, and test such respirator and component parts in accordance with the provisions of this part. If, upon completion of such examinations, inspections and tests, it is found that the prototype meets the minimum requirements set forth in this part, the Institute may inform the applicant, in writing, of the results of the examinations, inspections, and tests, and may require him to resubmit respirators and component parts made on regular production tooling, with no operations included which will not be incorporated in regular production processing, for further examination, inspection, and testing, prior to issuance of the certificate of approval.

(d) Applicants required to resubmit respirators and component parts made on regular production tooling, with no operation included which will not be incorporated in regular production processing, shall be charged fees in accordance with subpart C of this part.

(a) The certificate of approval shall contain a classification and a description of the respirator or combination of respirators for which it is issued, as provided in this part.

(b) The certificate of approval shall specifically set forth any restrictions or limitations on the respirator's use in hazardous atmospheres.

(c) Each certificate of approval shall be accompanied by the drawings and specifications (and lists thereof) submitted by the applicant in accordance with § 84.11. These drawings and specifications shall be referenced in the certificate of approval, and shall be maintained by the applicant. The drawings and specifications listed in each certificate of approval shall set forth in detail the design and construction requirements which shall be met by the applicant during commercial production of the respirator.

(d) Each certificate of approval shall be accompanied by a reproduction of the approval label design to be employed by the applicant with each approved respirator, as provided in § 84.33.

(e) No test data or specific laboratory findings will accompany any certificate of approval, however, the Institute will release pertinent test data and specific findings upon written request by the applicant, or as required by statute or regulation.

(f) Each certificate of approval shall also contain the approved quality control plan as specified in § 84.42.

(a) If, upon the completion of the examinations, inspections, and tests required to be conducted in accordance with the provisions of this part, it is found that the respirator does not meet the minimum requirements set forth in this part, the Institute shall issue a written notice of disapproval to the applicant.

(b) Each notice of disapproval shall be accompanied by all pertinent data or findings with respect to the defects of the respirator for which approval was sought with a view to the possible correction of any such defects.

(c) The Institute shall not disclose, except to the applicant or as required by statute or regulation, any data, findings, or other information with respect to any respirator for which a notice of disapproval is issued.

(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to the Institute for approval.

(b) Approval labels shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.

(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.

(d) Approval labels and markings shall only be used by the applicant to whom they were issued.

(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:

(f) The use of any Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.

(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.

(a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of the original certificate of approval issued by the Institute for such respirator by filing an application for such modification in accordance with the provisions of this section.

(b) Applications shall be submitted as for an original certificate of approval, with a request for a modification of the existing certificate to cover any proposed change.

(c) The application shall be accompanied by appropriate drawings and specifications, and by a proposed quality control plan which meets the requirements of subpart E of this part.

(d) The application for modification, together with the accompanying material, shall be examined by the Institute to determine whether testing will be required.

(e) The Institute shall inform the applicant of the fee required for any additional testing and the applicant will be charged for the actual cost of any examination, inspection, or test required, and such fees shall be submitted in accordance with the provisions of subpart C of this part.

(f) If the proposed change or modification meets the requirements of this part, a formal certificate of modification will be issued, accompanied, where necessary, by a list of new and revised drawings and specifications covering the change(s) and reproductions of revised approval labels.

(a) Each quality control plan shall contain provisions for the management of quality, including:

(b) Each provision for incoming and final inspection in the quality control plan shall include a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure, or an approved combination of sampling procedures. The procedure of Military Standard MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. Incoming bulk raw material inspection or verification of specification, and in-process inspection shall be sufficient to ensure control of product quality through the manufacturing cycle.

(c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent.

(d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped into the following classes:

(e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail.

(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.

(g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be:

(h) Except as provided in paragraph (i) of this section, inspection level IV as described in MIL-STD-414, 11 June 1957, including Change Notice No.1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an equivalent procedure, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics. Inspection level II as described in MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent procedure.

(i) Subject to the approval of the Institute, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication, inspections are adequate to ensure control of finished article quality, destructive testing of finished articles may be conducted at a lower level of inspection than that specified in paragraph (h) of this section.

(a) Each proposed quality control plan submitted in accordance with this subpart shall be reviewed by the Institute to determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for which an approval is sought.

(b) If the Institute determines that the proposed quality control plan submitted by the applicant will not ensure adequate quality control, the Institute shall require the applicant to modify the procedures and testing requirements of the plan prior to approval of the plan and issuance of any certificate of approval.

(c) Approved quality control plans shall constitute a part of and be incorporated into any certificate of approval issued by the Institute, and compliance with such plans by the applicant shall be a condition of approval.

(a) The applicant shall keep quality control inspection records sufficient to carry out the procedures required in MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure. MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an approved equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(b) The Institute reserves the right to have its representatives inspect the applicant's quality control test methods, equipment, and records, and to interview any employee or agent of the applicant in regard to quality control test methods, equipment, and records.

(c) The Institute reserves the right to revoke, for cause, any certificate of approval where it is found that the applicant's quality control test methods, equipment, or records do not ensure effective quality control over the respirator for which the approval was issued.

(a) Entry and escape. Respirators designed and approved for use during entry into a hazardous atmosphere, and for escape from a hazardous atmosphere; or

(b) Escape only. Respirators designed and approved for use only during escape from a hazardous atmosphere.

(a) Oxygen deficiency;

(b) Gases and vapors; and

(c) Particles, including dusts, fumes and mists.

(a) Respirators described in subparts H through L of this part shall be classified, where applicable, as approved for use during the following prescribed service times:

(b) Other service times may be prescribed by the Institute.

(a) The Institute shall issue approvals for the types of respirators described in subparts H through O of this part which have met the minimum requirements set forth for such respirators in this part.

(b) In addition to the types of respirators specified in subparts H through L of this part, the Institute shall issue approvals for other respiratory protective devices not specifically described in this part subject to such additional requirements as may be imposed in accordance with § 84.63(c).

(a) Respirators will not be accepted by the Institute for examination, inspection and testing unless they are designed on sound engineering and scientific principles, constructed of suitable materials and evidence good workmanship.

(b) Respirator components which come into contact with the wearer's skin shall be made of nonirritating materials.

(c) Components replaced during or after use shall be constructed of materials which will not be damaged by normal handling.

(d) Mouthpieces, hoods, helmets, and facepieces, except those employed in single-use respirators, shall be constructed of materials which will withstand repeated disinfection as recommended by the applicant in his instructions for use of the device.

(a) The component parts of each respirator shall be:

(b) Replacement parts shall be designed and constructed to permit easy installation and to maintain the effectiveness of the respirator.

(a) Each respirator and respirator component shall when tested by the applicant and by the Institute, and meet the applicable requirements set forth in subparts H through O of this part.

(b) Where a combination respirator is assembled from two or more types of respirators, as described in this part, each of the individual respirator types which have been combined shall, as applicable, meet the minimum requirements for such respirators set forth in subparts H through O of this part, and such combination respirators, except as specified in § 84.70(b)(2), will be classified by the type of respirator in the combination which provides the least protection to the user.

(c) In addition to the minimum requirements set forth in subparts H through O of this part, the Institute reserves the right to require, as a further condition of approval, any additional requirements deemed necessary to establish the quality, effectiveness, and safety of any respirator used as protection against hazardous atmospheres.

(d) Where it is determined after receipt of an application that additional requirements will be required for approval, the Institute will notify the applicant in writing of these additional requirements, and necessary examinations, inspections, or tests, stating generally the reasons for such requirements, examinations, inspections, or tests.

(a) Prior to making or filing any application for approval or modification of approval, the applicant shall conduct, or cause to be conducted, examinations, inspections, and tests of respirator performance which are equal to or exceed the severity of those prescribed in this part.

(b) With the application, the applicant shall provide a statement to the Institute showing the types and results of the examinations, inspections, and tests required under paragraph (a) of this section and state that the respirator meets the minimum requirements of subparts H through O of this part, as applicable. Complete examination, inspection, and test data shall be retained on file by the applicant and be submitted, upon request, to the Institute.

(c) The Institute may, upon written request by the applicant, provide drawings and descriptions of its test equipment and otherwise assist the applicant in establishing a test laboratory or securing the services of a testing agency.

(d) No approval will be issued until the Institute has validated the applicant's test results.

(a) All examinations, inspections, and tests conducted pursuant to subparts H through O of this part will be under the sole direction and control of the Institute.

(b) The Institute may, as a condition of approval, require the assistance of the applicant or agents of the applicant during the assembly, disassembly, or preparation of any respirator or respirator component prior to testing or in the operation of such equipment during testing.

(c) Only Institute personnel, persons assisting the Institute pursuant to paragraph (b) of this section, and such other persons as are requested by the Institute or the applicant to be observers, shall be present during any examination, inspection, or test conducted prior to the issuance of an approval by the Institute for the equipment under consideration.

(d) The Institute shall hold as confidential any analyses, drawings, specifications, or materials submitted by the applicant and shall not disclose any principles or patentable features of such equipment, except as required by statute or regulation.

(e) As a condition of each approval issued for any respirator, the Institute reserves the right, following the issuance of such approval, to conduct such public tests and demonstrations of the approved respiratory equipment as is deemed appropriate.

(a) Any applicant may, upon a written request submitted to the Institute, withdraw any application for approval of any respirator.

(b) Upon the receipt of a written request from the applicant for the withdrawal of an application, NIOSH will invoice the applicant based on the fee calculated, as specified under § 84.21(e).

(a) Self-contained breathing apparatus, including all completely assembled, portable, self-contained devices designed for use as respiratory protection during entry into and escape from or escape only from hazardous atmospheres, are described as follows:

(b) The following respirators may be classified as designed and approved for use during emergency entry into a hazardous atmosphere:

(c) Self-contained breathing apparatus classified for less than 1 hour service time will not be approved for use during underground mine rescue and recovery operations except as auxiliary equipment.

(d) Self-contained breathing apparatus classified for less than 30 minutes' service time will not be approved for use as auxiliary equipment during underground mine rescue and recovery operations.

(a) Each self-contained breathing apparatus described in § 84.70 shall, where its design requires, contain the following component parts:

(b) The components of each self-contained breathing apparatus shall meet the minimum construction requirements set forth in subpart G of this part.

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces and mouthpieces;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each apparatus shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the apparatus in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of apparatus parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Apparatus may be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains, and all appropriate approval labels.

(b) Containers supplied by the applicant for carrying or storing self-contained breathing apparatus will be inspected, examined, and tested as components of the respirator for which approval is sought.

(c) Containers for self-contained breathing apparatus shall be designed and constructed to permit easy removal of the apparatus.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes, either:

(b) Full facepieces shall provide for the optional use of corrective spectacles or lenses which shall not reduce the respiratory protective qualities of the apparatus.

(c) Apparatus with mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or apparatus and provide an airtight seal.

(d) Facepieces shall be designed to prevent eyepiece, spectacle, and lens fogging.

(a) Facepieces shall be designed and constructed to provide adequate vision which is not distorted by the eyepiece.

(b) All eyepieces shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(a) Inhalation and exhalation valves shall be provided where necessary and protected against damage and distortion.

(b) Exhalation valves shall be—

(a) Facepieces shall be equipped with adjustable and replaceable head harnesses designed and constructed to provide adequate tension during suspension and an even distribution of pressure over the entire area in contact with the face.

(b) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses designed and constructed to hold the mouthpiece in place.

(a) Breathing gas used to supply apparatus shall be respirable and contain no less than 19.5 (dry atmosphere) volume percent of oxygen.

(b) Oxygen, including liquid oxygen, shall contain not less than 99.0 percent, by volume, of pure O₂, not more than 0.03%, by volume, carbon dioxide, and not more than 0.001%, by volume, carbon monoxide. Methods for making these determinations can be found in the U.S. Pharmacopeia National Formulary. Containers used for oxygen must not be treated with any toxic, sleep-inducing, narcosis-producing, or respiratory tract irritating compounds.

(c) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Compressed, liquefied breathing air shall meet the applicable minimum grade requirements for Type II liquid air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade B or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(a) Compressed breathing gas and liquefied breathing gas containers shall meet the minimum requirements of the Department of Transportation for interstate shipment of such containers when fully charged.

(b) Such containers shall be permanently and legibly marked to identify their contents, e.g., compressed breathing air, compressed breathing oxygen, liquefied breathing air, or liquefied breathing oxygen.

(c) Containers normally removed from apparatus for refilling shall be equipped with a dial indicating gage which shows the pressure in the container.

(d) Compressed breathing gas contained valves or a separate charging system or adapter provided with each apparatus shall be equipped with outlet threads specified for the service by the American Standards Association, Compressed Gas Cylinder Valve Outlet and Inlet Connections, B57.1-1965. B57.1-1965 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(a) Gas pressure gages employed on compressed breathing gas containers shall be calibrated in pounds per square inch.

(b) Liquid-level gages shall be calibrated in fractions of total container capacity, or in units of liquid volume.

(c) Gas pressure gages other than those specified in paragraphs (a) and (b) of this section shall be calibrated in:

(d)

(e)

(f) The loss of gas through a broken gage or severed gage connection shall not exceed 70 liters per minute when the cylinder pressure is 6,900 kN/m.² (1,000 pounds per square inch gage) or when the liquid level is at one-half.

(g) Where gages are connected to the apparatus through a gage line, the gage and line shall be capable of being isolated from the apparatus except where the failure of the gage or line would not impair the performance or service life of the apparatus.

(h) Oxygen pressure gages shall have the words “Oxygen” and “Use No Oil” marked prominently on the gage.

(i)

(a) Elapsed time indicators shall be provided for apparatus with a chemical oxygen source, except:

(b) The timer or other indicator shall be accurately calibrated in minutes of remaining service life.

(c) Timers shall be readable by sight and by touch during use by the wearer.

(d) Timers shall be equipped with automatically preset alarms which will warn the wearer for a period of 7 seconds or more after the preset time has elapsed.

(e) Remaining service-life indicators or warning devices shall be provided in addition to a pressure gage on compressed gas self-contained breathing apparatus, except apparatus used for escape only, and shall operate automatically without preadjustment by the wearer.

(f) Each remaining service-life indicator or warning device must give an alarm when the remaining service life is reduced to a minimum of 25 percent of its rated service time or any higher minimum percent value or values as specified in the approval. Open-circuit demand and pressure-demand respirators must alarm continuously until depletion of the breathing air supply. The percent value set for indicator activation must be identified by labels and/or markings on each respirator unit.

(a) Hand-operated valves shall be designed and constructed to prevent removal of the stem from the valve body during normal usage to insure against a sudden release of the full pressure of the container when the valve is opened.

(b) Valves shall be designed or positioned to prevent accidental opening and closing, and damage from external forces.

(c) Valves operated during use of the apparatus shall be installed in locations where they can be readily adjusted by the wearer.

(d) Main-line valves, designed and constructed to conserve gas in the event of a regulator or demand valve failure, shall be provided in addition to gas container valves, except when such failure will not affect performance.

(e) Hand-operated bypass systems designed and constructed to permit the wearer to breathe and to conserve his gas supply in the event of a regulator or demand valve failure, shall be provided where necessary.

(f) Valves installed on apparatus shall be clearly distinguishable from one another by sight and touch.

(g) The bypass system valve control shall be colored red.

(h) A main-line or bypass valve or system will not be required on apparatus for escape only.

(i) Safety relief valves or systems, designed and constructed to release excess pressure in the breathing circuit, shall be provided on closed-circuit apparatus, and shall meet the following requirements:

(a) Breathing bags shall have sufficient volume to prevent gas waste during exhalation and to provide an adequate reserve for inhalation.

(b) Breathing bags shall be constructed of materials which are flexible and resistant to gasoline vapors.

(c) Breathing bags shall be installed in a location which will protect them from damage or collapse by external forces, except on apparatus classified for escape only.

(a) Breathing bags will be tested in an air atmosphere saturated with gasoline vapor at room temperature (24-30 °C./75-85 °F.) for a continuous period of twice the rated time of the apparatus (except for apparatus for escape only where the test period shall be the rated time of the apparatus).

(b) The bag will be operated during this test by a breathing machine with 24 respirations per minute and a minute-volume of 40 liters.

(c) A breathing machine cam with a work rate of 622 kp.-m./min. will be used. The dimensions of a suitable breathing machine cam are available from the Institute upon request.

(d) The air within the bag(s) shall not contain more than 100 parts per million of gasoline vapor at the end of the test.

(a) The completely assembled and fully charged apparatus shall not weigh more than 16 kg. (35 pounds); however, where the weight decreases by more than 25 percent of its initial charge weight during its rated service life, the maximum allowable weight of a completely assembled and fully charged apparatus shall be 18 kg. (40 pounds).

(b) Where an apparatus employs equipment which contributes materially to the wearer's comfort, e.g., a cooling system, the completely assembled and fully charged apparatus shall not weigh more than 18 kg. (40 pounds) regardless of the decrease in weight during use.

(a) Resistance to inhalation airflow will be measured in the facepiece or mouthpiece while the apparatus is operated by a breathing machine as described in § 84.88.

(b) The inhalation resistance of open-circuit apparatus shall not exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120 liters per minute).

(c) The inhalation resistance of closed-circuit apparatus shall not exceed the difference between exhalation resistance (§ 84.91(e)) and 10 cm. (4 inches) water-column height.

(a) Resistance to exhalation airflow will be measured in the facepiece or mouthpiece of open-circuit apparatus with air flowing at a continuous rate of 85 liters per minute.

(b) The exhalation resistance of demand apparatus shall not exceed 25 mm. (1 inch) water-column height.

(c) The exhalation resistance of pressure-demand apparatus shall not exceed the static pressure in the facepiece by more than 51 mm. (2 inches) water-column height.

(d) The static pressure (at zero flow) in the facepiece shall not exceed 38 mm. (1.5 inches) water-column height.

(e) Resistance to exhalation airflow will be measured in the facepiece or mouthpiece of closed-circuit apparatus with a breathing machine as described in § 84.88, and the exhalation resistance shall not exceed 51 mm. (2 inches) water-column height.

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. (1 inch) water-column height while in a normal operating position.

(b) Leakage between the valve and the valve seat shall not exceed 30 milliliters per minute.

(a) A static-flow test will be performed on all open-circuit apparatus.

(b) The flow from the apparatus shall be greater than 200 liters per minute when the pressure in the facepiece of demand-apparatus is lowered by 51 mm. (2 inches) water-column height when full container pressure is applied.

(c) Where pressure demand apparatus are tested, the flow will be measured at zero gage pressure in the facepiece.

(d) Where apparatus with compressed-breathing-gas containers are tested, the flow test shall also be made with 3,450 kN/m.² (500 p.s.i.g.) container pressure applied.

(a) Where oxygen is supplied by a constant-flow device only, the rate of flow shall be at least 3 liters per minute for the entire rated service time of the apparatus.

(b) Where constant flow is used in conjunction with demand flow, the constant flow shall be greater than 1.5 liters per minute for the entire rated service time.

(c) All demand-flow devices shall provide at least 30 liters of oxygen per minute when in the fully open position.

(a) Service time will be measured with a breathing machine as described in § 84.88.

(b) The open-circuit apparatus will be classified according to the length of time it supplies air or oxygen to the breathing machine.

(c) The service time obtained on this test will be used to classify the open-circuit apparatus in accordance with § 84.53.

(a) The closed-circuit apparatus will be classified according to the length of time it supplies adequate breathing gas to the wearer during man test No. 4 described in Table 4 of this subpart.

(b) The service time obtained on man test No. 4 will be used to classify the closed-circuit apparatus in accordance with § 84.53.

(a) Open-circuit apparatus.

(b) Closed-circuit apparatus. The concentration of carbon dioxide in inspired gas in closed-circuit apparatus will be measured at the mouth while the parts of the apparatus contributing to dead-air space are mounted on a dummy head and operated by the breathing machine as in paragraphs (a) (1) through (5) of this section.

(c) During the testing required by paragraphs (a) and (b) of this section, the concentration of carbon dioxide in inspired gas at the mouth will be continuously recorded, and the maximum average concentration during the inhalation portion of the breathing cycle shall not exceed the following limits:

(d) In addition to the test requirements for closed-circuit apparatus set forth in paragraph (b) of this section, gas samples will be taken during the course of the man tests described in Tables 1, 2, 3, and 4 of this subpart. These gas samples will be taken from the closed-circuit apparatus at a point downstream of the carbon dioxide sorbent, and they shall not contain more than 0.5 percent carbon dioxide at any time, except on apparatus for escape only, using a mouthpiece only, the sample shall not contain more than 1.5 percent carbon dioxide at any time.

(a) The applicant shall specify the minimum temperature for safe operation and two persons will perform the tests described in paragraphs (c) and (d) of this section, wearing the apparatus according to applicant's directions. At the specified temperature, the apparatus shall meet all the requirements described in paragraph (e) of this section.

(b) The apparatus will be precooled at the specified minimum temperature for 4 hours.

(c) The apparatus will be worn in the low temperature chamber for 30 minutes, or for the service time of the apparatus, whichever is less.

(d) During the test period, alternate 1-minute periods of exercise and rest will be required with the exercise periods consisting of stepping onto and off a box 21.5 cm. (81⁄2 inches) high at a rate of 30 cycles per minute.

(e)

(f) Auxiliary low-temperature parts which are commercially available to the user may be used on the apparatus to meet the requirements described in paragraph (e) of this section.

(a) The man tests described in Tables 1, 2, 3, and 4 of this subpart represent the workload performed in the mining, mineral, or allied industries by a person wearing the apparatus tested.

(b) The apparatus tested will be worn by Institute personnel trained in the use of self-contained breathing apparatus, and the wearer will, before participating in these tests, pass a physical examination conducted by a qualified physician.

(c) All man tests will be conducted by the Institute.

(d) The apparatus will be examined before each man test to ensure that it is in proper working order.

(e) Breathing resistance will be measured within the facepiece or mouthpiece and the wearer's pulse and respiration rate will be recorded during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.

(f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.

(g) If man tests are not completed through no fault of the apparatus, the test will be repeated.

(a) Familiarize the wearer with the apparatus during use;

(b) Provide for a gradual increase in activity;

(c) Evaluate the apparatus under different types of work and physical orientation; and

(d) Provide information on the operating and breathing characteristics of the apparatus during actual use.

(a) Test 5 will be conducted to determine the maximum length of time the apparatus will supply the respiratory needs of the wearer while he is sitting at rest.

(b) The wearer will manipulate the devices controlling the supply of breathing gas to the advantage of the apparatus.

(c) Samples of inspiration from within the apparatus facepiece or mouthpiece shall be taken once every 15 minutes, and shall meet the minimum requirement for oxygen specified in § 84.79(a), and the maximum allowable average concentration of carbon dioxide specified in § 84.97(c).

(d) One sample of inspiration will be taken in the case of 3-, 5-, and 10-minute apparatus.

(a) Man test 6 will be conducted with respect to liquefied breathing gas apparatus only.

(b) This test will be conducted to evaluate operation of the apparatus in other than vertical positions.

(c) The wearer will lie face downward for one-fourth the service life of the apparatus with a full charge of liquefied breathing gas, and then a one-quarter full charge of liquefied breathing gas.

(d) The test will be repeated with the wearer lying on each side and on his back.

(e) The oxygen content of the gas supplied to the wearer by the apparatus will be continuously measured.

(a) The apparatus shall satisfy the respiratory requirements of the wearer for the classified service time.

(b) Fogging of the eyepiece shall not obscure the wearer's vision, and the wearer shall not experience undue discomfort because of fit or other characteristics of the apparatus.

(c) When the ambient temperature during testing is 24 ±6 °C. (75 ±10 °F.), the maximum temperature of inspired air recorded during man tests shall not exceed the following, after correction for deviation from 24 °C. (75 °F.):

(a) Each apparatus will be tested for tightness by persons wearing it in an atmosphere of 1,000 p.p.m. isoamyl acetate.

(b) Six persons will each wear the apparatus in the test concentrations specified in paragraph (a) of this section for 2 minutes and none shall detect the odor or taste of the test vapor.

(a) Gas masks including all completely assembled air purifying masks designed for use as respiratory protection during entry into atmospheres not immediately dangerous to life or health or escape only from hazardous atmospheres containing adequate oxygen to support life are described as follows:

(b) Gas masks shall be further described according to the types of gases or vapors against which they are designed to provide respiratory protection, as follows:

(c) Gas masks for respiratory protection against gases and vapors other than those specified in paragraph (b) of this section, may be approved upon submittal of an application in writing for approval to the National Personal Protective Technology Laboratory listing the gas or vapor and suggested maximum use concentration for the specific type of gas mask. The Institute will consider the application and accept or reject it on the basis of effect on the wearer's health and safety and any field experience in use of gas masks for such exposures. If the application is accepted, the Institute will test such masks in accordance with the requirements of this subpart.

(a) Each gas mask described in § 84.110 shall, where its design requires, contain the following component parts:

(b) The components of each gas mask shall meet the minimum construction requirements set forth in subpart G of this part.

(a) Particulate matter filters used in conjunction with a canister or cartridge shall be located on the inlet side of the canister or cartridge.

(b) Filters shall be incorporated in or firmly attached to the canister or cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement in the canister or cartridge.

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces or mouthpieces;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each gas mask shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the gas mask in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of gas mask parts, and where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Gas masks shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of mask it contains and all appropriate approval labels.

(b) Containers for gas masks shall be designed and constructed to permit easy removal of the mask.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:

(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the gas mask.

(c) Half-mask facepieces shall not interfere with the fit of common industrial safety spectacles, as determined by the Institute's facepiece tests in § 84.124.

(d) Gas masks with mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or gas mask and provide an airtight seal.

(e) Facepieces shall be designed to prevent eyepiece fogging.

(a) Full facepieces shall be designed and constructed to provide adequate vision which is not distorted by the eye.

(b) All eyepieces shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(a) Inhalation and exhalation valves shall be provided where necessary and protected against damage and distortion.

(b) Inhalation valves shall be designed and constructed to prevent excessive exhaled air from adversely affecting cartridges, canisters, and filters.

(c) Exhalation valves shall be protected against external influence, and designed and constructed to prevent inward leakage of contaminated air.

(a) Facepieces shall be equipped with adjustable and replaceable head harnesses, designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.

(b) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses designed and constructed to hold the mouthpiece in place.

(a) Resistance to airflow will be measured in the facepiece or mouthpiece of a gas mask mounted on a breathing machine both before and after each test conducted in accordance with §§ 84.124, 84.125, and 84.126, with air flowing at a continuous rate of 85 liters per minute.

(b) The maximum allowable resistance requirements for gas masks are as follows:

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.

(a) The complete gas mask will be fitted to the faces of persons having varying facial shapes and sizes.

(b) Where the applicant specifies a facepiece size or sizes for the gas mask, together with the approximate measurements of faces they are designed to fit, the Institute will insure that test subjects suit such facial measurements.

(c) Any gas mask parts which must be removed to perform the facepiece or mouthpiece fit test shall be replaceable without special tools and without disturbing the facepiece or mouthpiece fit.

(d) The facepiece or mouthpiece fit test, using positive or negative pressure recommended by the applicant and described in his instructions will be used before each test specified in paragraph (e) of this section, and in § 84.125.

(e)

(a)

(b) Front-mounted and back-mounted gas mask canisters will be tested and shall meet the minimum requirements set forth in Table 5 of this subpart.

(c)

(d) Chin-style gas mask canisters shall meet the minimum requirements set forth in Table 6 of this subpart.

(e) Escape gas mask canisters shall meet the minimum requirements set forth in Table 7 of this subpart.

(f) Powered air-purifying respirators with a canister(s) and particulate filter(s) must meet the as-received minimum service-life requirements and half of the equilibrated minimum service-life requirements set forth in Tables 5, 6, and 7 of subpart I using the flows specified in subpart K, § 84.175(b) and equilibrated in accordance with paragraphs (a) through (e) of this section using the flows specified in subpart K, § 84.175(b).

(a) Type “A” supplied-air respirators. A hose mask respirator, for entry into and escape from atmospheres not immediately dangerous to life or health, which consists of a motor-driven or hand-operated blower that permits the free entrance of air when the blower is not operating, a strong large-diameter hose having a low resistance to airflow, a harness to which the hose and the life-line are attached and a tight-fitting facepiece.

(b) Type “AE” supplied-air respirators. A Type “A” supplied-air respirator equipped with additional devices designed to protect the wearer's head and neck against impact and abrasion from rebounding abrasive material, and with shielding material such as plastic, glass, woven wire, sheet metal, or other suitable material to protect the window(s) of facepieces, hoods, and helmets which do not unduly interfere with the wearer's vision and permit easy access to the external surface of such window(s) for cleaning.

(c) Type “B” supplied-air respirators. A hose mask respirator, for entry into and escape from atmospheres not immediately dangerous to life or health, which consists of a strong large-diameter hose with low resistance to airflow through which the user draws inspired air by means of his lungs alone, a harness to which the hose is attached, and a tight-fitting facepiece.

(d) Type “BE” supplied-air respirators. A type “B” supplied-air respirator equipped with additional devices designed to protect the wearer's head and neck against impact and abrasion from rebounding abrasive material, and with shielding material such as plastic, glass, woven wire, sheet metal, or other suitable material to protect the window(s) of facepieces, hoods, and helmets which do not unduly interfere with the wearer's vision and permit easy access to the external surface of such window(s) for cleaning.

(e) Type “C” supplied-air respirators. An airline respirator, for entry into and escape from atmospheres not immediately dangerous to life or health, which consists of a source of respirable breathing air, a hose, a detachable coupling, a control valve, orifice, a demand valve or pressure demand valve, an arrangement for attaching the hose to the wearer, and a facepiece, hood, or helmet.

(f) Type “CE” supplied-air respirators. A type “C” supplied-air respirator equipped with additional devices designed to protect the wearer's head and neck against impact and abrasion from rebounding abrasive material, and with shielding material such as plastic, glass, woven wire, sheet metal, or other suitable material to protect the window(s) of facepieces, hoods, and helmets which do not unduly interfere with the wearer's vision and permit easy access to the external surface of such window(s) for cleaning.

(a) Each supplied-air respirator described in § 84.130 shall, where its design requires, contain the following component parts:

(b) The component parts of each supplied-air respirator shall meet the minimum construction requirements set forth in subpart G of this part.

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each supplied-air respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts, and where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:

(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.

(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.

(d) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.

(a) Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepiece.

(b) All eyepieces except those on Types B, BE, C, and CE supplied-air respirators shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236.

(c)

(a) Inhalation and exhalation valves shall be provided where necessary and protected against distortion.

(b) Exhalation valves shall be:

(c) Check valves designed and constructed to allow airflow toward the facepiece only shall be provided in the connections to the facepiece or in the hose fitting near the facepiece of all Type A, AE, B, and BE supplied-air respirators.

(a) Breathing gas used to supply supplied-air respirators shall be respirable breathing air and contain no less than 19.5 volume-percent of oxygen.

(b) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) Compressed, liquefied breathing air shall meet the applicable minimum grade requirements for Type II liquid air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade B or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, National Personal Protective Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(a) Blowers shall be designed and constructed to deliver an adequate amount of air to the wearer with either direction of rotation, unless constructed to permit rotation in one direction only, and to permit the free entrance of air to the hose when the blower is not operated.

(b) No multiple systems, whereby more than one user is supplied by one blower, will be approved, unless each hose line is connected directly to a manifold at the blower.

(a) Blowers or connections to air supplies providing positive pressures shall not be approved for use on Type B supplied-air respirators.

(b) Terminal fittings or chambers employed in Type B supplied-air respirators, shall be:

(a) Hand-operated blowers shall be tested by attaching them to a mechanical drive and operating them 6 to 8 hours daily for a period of 100 hours at a speed necessary to deliver 50 liters of air per minute through each completely assembled respirator. Each respirator shall be equipped with the maximum length of hose with which the device is to be approved and the hose shall be connected to each blower or manifold outlet designed for hose connections.

(b) The crank speed of the hand-operated blower shall not exceed 50 revolutions per minute in order to deliver the required 50 liters of air per minute to each facepiece.

(c) The power required to deliver 50 liters of air per minute to each wearer through the maximum length of hose shall not exceed one-fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. (5 pounds) on a 20 cm. (8-inch) crank, as defined in § 84.146.

(d) The blower shall operate throughout the period without failure or indication of excessive wear of bearings or other working parts.

(a) Motor-operated blowers shall be tested by operating them at their specified running speed 6 to 8 hours daily for a period of 100 hours when assembled with the kind and maximum length of hose for which the device is to be approved and when connected to each blower or manifold outlet designed for hose connections.

(b) The connection between the motor and the blower shall be so constructed that the motor may be disengaged from the blower when the blower is operated by hand.

(c) The blower shall operate throughout the period without failure or indication of excessive wear of bearings or other working parts.

(d) Where a blower, which is ordinarily motor driven, is operated by hand, the power required to deliver 50 liters of air per minute to each wearer through the maximum length of hose shall not exceed one-fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. (5 pounds) on a 20 cm. (8-inch) crank, as defined in § 84.146.

(e) Where the respirator is assembled with the facepiece and 15 m. (50 feet) of the hose for which it is to be approved, and when connected to one outlet with all other outlets closed and operated at a speed not exceeding 50 revolutions of the crank per minute, the amount of air delivered into the respiratory-inlet covering shall not exceed 150 liters per minute.

(a) Respirators tested under this section shall be approved only when they supply respirable air at the pressures and quantities required.

(b) The pressure at the inlet of the hose connection shall not exceed 863 kN/m.² (125 pounds per square inch gage).

(c) Where the pressure at any point in the supply system exceeds 863 kN/m.² (125 pounds per square inch gage), the respirator shall be equipped with a pressure-release mechanism that will prevent the pressure at the hose connection from exceeding 863 kN/m.² (125 pounds per square inch gage) under any conditions.

(a) Respirators tested under this section shall be approved only when used to supply respirable air at the pressures and quantities required.

(b) The manufacturer shall specify the range of air pressure at the point of attachment of the air-supply hose to the air-supply system, and the range of hose length for the respirator. For example, he might specify that the respirator be used with compressed air at pressures ranging from 280-550 kN/m.² (40 to 80 pounds per square inch) with from 6 to 76 m. (15 to 250 feet) of air-supply hose.

(c) The specified air pressure at the point of attachment of the hose to the air-supply system shall not exceed 863 kN/m.² (125 pounds per square inch gage).

(d)

(a)

(b)

(c) The harness employed on Type C respirators shall be similar to that required on the Type B respirator, or, it may consist of a simple arrangement for attaching the hose to a part of the wearer's clothing in a practical manner that prevents a pull equivalent to dragging the maximum length of the hose over a concrete floor from exerting pull upon the respiratory-inlet covering.

(d) Where supplied-air respirators have a rigid or partly rigid head covering, a suitable harness shall be required to assist in holding this covering in place.

(a)

(b) Breathing tubes employed on Type C supplied-air respirators of the continuous flow class shall meet the minimum requirements set forth in paragraph (a) of this section, however, an extension of the connecting hose may be employed in lieu of the breathing tubes required.

(c)

(a) Airflow resistance will be determined when the respirator is completely assembled with the respiratory-inlet covering, the air-supply device, and the maximum length of air-supply hose coiled for one-half its length in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.

(b) The inhalation resistance, drawn at the rate of 85 liters (3 cubic feet) per minute when the blower is not operating or under any practical condition of blower operation shall not exceed the following amounts:

(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of water-column height at a flow rate of 85 liters (3 cubic feet) per minute when the blower is not operating or under any practical condition of blower operation.

(a) Airflow resistance shall be determined when the respirator is completely assembled with the respiratory-inlet covering and the hose in the maximum length to be considered for approval, coiled in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.

(b) Airflow resistance shall not exceed 38 mm. (1.5 inches) of water-column height to air drawn at the flow rate of 85 liters (3 cubic feet) per minute.

(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of water-column height at this flow rate.

(a) Inhalation resistance shall not exceed 50 millimeters (2 inches) of water at an air flow of 115 liters (4 cubic feet) per minute.

(b) The exhalation resistance to a flow of air at a rate of 85 liters (3 cubic feet) per minute shall not exceed 25 millimeters (1 inch) of water.

(a) The static pressure in the facepiece shall not exceed 38 mm. (1.5 inches) of water-column height.

(b) The pressure in the facepiece shall not fall below atmospheric at inhalation airflows less than 115 liters (4 cubic feet) per minute.

(c) The exhalation resistance to a flow of air at a rate of 85 liters (3 cubic feet) per minute shall not exceed the static pressure in the facepiece by more than 51 mm. (2 inches) of water-column height.

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.

(a) Wearers will enter a chamber containing a gas or vapor as prescribed in §§ 84.160, 84.161, 84.162, and 84.163.

(b) Each wearer will spend 10 minutes in work to provide observations on freedom of the device from leakage. The freedom and comfort allowed the wearer will also be considered.

(c) Time during the test period will be divided as follows:

(d) No odor of the test gas or vapor shall be detected by the wearer in the air breathed during any such test, and the wearer shall not be subjected to any undue discomfort or encumbrance because of the fit, air delivery, or other features of the respirator during the testing period.

(a) The completely assembled respirator will be worn in a chamber containing 0.1 ±0.025 percent isoamyl acetate vapor, and the blower, the intake of the hose, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.

(b) The man in the isoamyl acetate atmosphere will draw his inspired air through the hose, connections, and all parts of the air device by means of his lungs alone (blower not operating).

(c) The 10-minute work test will be repeated with the blower in operation at any practical speed up to 50 revolutions of the crank per minute.

(a) The completely assembled respirator will be worn in a chamber containing 0.1 ±0.025 percent isoamyl acetate vapor, and the intake of the hose, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.

(b) The man in the isoamyl acetate atmosphere will draw his inspired air through the hose and connections by means of his lungs alone.

(a) The completely assembled respirator will be worn in a chamber containing 0.1 ±0.025 percent isoamyl acetate vapor, the intake of the hose will be connected to a suitable source of respirable air, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.

(b) The minimum flow of air required to maintain a positive pressure in the respiratory-inlet covering throughout the entire breathing cycle will be supplied to the wearer, provided however, that airflow shall not be less than 115 liters per minute for tight-fitting and not less than 170 liters per minute for loose-fitting respiratory inlet-coverings.

(c) The test will be repeated with the maximum rate of flow attainable within specified operating pressures.

(a) The completely assembled respirator will be worn in a chamber containing 0.1 ±0.025 percent isoamyl acetate vapor, the intake of the hose will be connected to a suitable source of respirable air, and not more than 25 percent of the hose length will be located in isoamyl acetate-free air.

(b) The test will be conducted at the minimum pressure with the maximum hose length and will be repeated at the maximum pressure with the minimum hose length.

(a) Non-powered air-purifying particulate respirators (series N, R, and P).

(b) Powered air-purifying particulate respirators (PAPR classes HE and PAPR100).

(a) Respiratory inlet covering.

(b) Filter unit. The respirator manufacturer, as part of the application for certification, must specify the filter series and the filter efficiency level (i.e., “N95,” “R95,” “P95,” “N99,” “R99,” “P99,” “N100,” “R100,” “P100,” “HE,” “PAPR100-N” or “PAPR100-P”) for which certification is being sought.

(c) Valves.

(d) Head harness.

(e) Breathing tube. Flexible breathing tubes used in conjunction with respirators must be designed and constructed to prevent:

(f) Drink tube.

(g) Container.

(h) Harness.

(i) Attached blower—PAPR classes HE and PAPR100. Blowers must be designed to achieve the air flow rates required by the testing standards in § 84.175.

(j) Low-flow warning device —PAPR class PAPR100.

(a) Resistance to airflow will be measured in the tight-fitting respiratory inlet covering of a complete particulate respirator mounted on a test fixture with air flowing at continuous rate of 85 ±2 liters per minute, before each test conducted in accordance with § 84.173.

(b) Resistance of a complete tight-fitting powered air-purifying particulate respirator system will be measured with the blower off if the manufacturer indicates that the respirator should not be doffed in the event of a blower failure.

(c) The maximum allowable resistance requirements for air-purifying particulate respirators are as follows:

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat must not exceed 30 mL per minute.

(a) Twenty filters of each non-powered air-purifying particulate respirator model will be tested for filter efficiency against:

(b) Filters including holders and gaskets, when separable, will be tested for filter efficiency level, as mounted on a test fixture in the manner as used on the respirator.

(c) Prior to filter efficiency testing of 20 N-series filters, the 20 to be tested will be taken out of their packaging and placed in an environment of 85 ± 5 percent relative humidity at 38 ± 2.5 °C for 25 ±1 hours. Following the pre-conditioning, filters will be sealed in a gas-tight container and tested within 10 hours.

(d) When the filters do not have separable holders and gaskets, the exhalation valves will be blocked so as to ensure that leakage, if present, is not included in the filter efficiency level evaluation.

(e) For non-powered air-purifying particulate respirators with a single filter, filters will be tested at a continuous airflow rate of 85 ± 4 liters per minute. Where filters are to be used in pairs, the test-aerosol airflow rate will be 42.5 ± 2 liters per minute through each filter.

(f) Filter efficiency test aerosols:

(g) The sodium chloride test aerosol will have a particle size distribution with count median diameter of 0.075 ± 0.020 µm and a standard geometric deviation not exceeding 1.86 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent. The DOP aerosol will have a particle size distribution with count median diameter of 0.185 ± 0.020 µm and a standard geometric deviation not exceeding 1.60 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent.

(h) The efficiency of the filter will be monitored and recorded throughout the test period by a suitable forward-light-scattering photometer or equivalent instrumentation.

(i) The minimum efficiency for each of the 20 filters will be determined and recorded and must be equal to or greater than the filter efficiency criterion listed for each level as follows:

(a) Three filters from each powered air-purifying particulate respirator for efficiency will be tested against a neat cold-nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25 ± 5 °C that has been neutralized to the Boltzmann equilibrium state.

(b) Single air-purifying particulate respirator filter units will be tested in an atmosphere concentration of 100 mg/m³ of DOP at the following continuous flow rates for a period of 5 to 10 seconds:

(c) Powered air-purifying particulate respirators with multiple filter units will be tested by dividing the flow rate specified in paragraph (b) of this section by the total number of filters used.

(d) The filter will be mounted on a connector in the same manner as used on the respirator and the total efficiency must be ≥99.97 percent.

(a) Isoamyl acetate (IAA) fit test. The applicant must provide a charcoal-filled canister or cartridge of a size and resistance similar to the filter unit with connectors which can be attached to the facepiece in the same manner as the filter unit.

(b) Generated aerosol fit test. The powered air-purifying particulate respirator system is tested in an atmosphere containing 20-40 mg/m³ corn oil aerosol having a mass median aerodynamic diameter of 0.4 to 0.6 µm.

(a) Minimum inhalation resistance must be greater than zero mm of water-column height.

(b) Maximum exhalation resistance must be less than 89 mm of water-column height.

(a) Three powered air-purifying particulate respirators will be tested for a period of 4 hours each at a flowrate not less than 115 liters per minute for tight-fitting facepieces, and not less than 170 liters per minute for loose-fitting hoods and helmets.

(b) The relative humidity in the test chamber will be 20-80 percent, and the room temperature approximately 25 °C.

(c) The test suspension in the chamber will not be less than 50 nor more than 60 mg of flint (99 + percent free silica) per m³ of air.

(d) The flint in suspension will be 99 + percent through a 270-mesh sieve.

(e) The particle-size distribution of the test suspension will have a geometric mean of 0.4 to 0.6 µm and the standard geometric deviation will not exceed 2.

(f) The total amount of unretained test suspension in samples taken during testing must not exceed 14.4 mg for a powered air-purifying particulate respirator with tight-fitting facepiece, and 21.3 mg for a powered air-purifying particulate respirator with loose-fitting hood or helmet.

(a) Twenty filters of each powered air-purifying particulate respirator design will be tested for filter efficiency against:

(b) Prior to filter efficiency testing of 20 series PAPR100-N filters, the 20 to be tested will be taken out of their packaging and placed in an environment of 85 ±5 percent relative humidity at 38 ±2.5 °C for 25 ±1 hours. Following the pre-conditioning, filters will be sealed in a gas-tight container and tested within 10 hours.

(c) For powered air-purifying particulate respirators with a single filter, filters will be tested at a continuous airflow rate of 85 ±4 liters per minute. Where filters are to be used in pairs, the test-aerosol airflow rate will be 42.5 ±2 liters per minute through each filter.

(d) Filter efficiency test aerosols:

(e) The test will continue until minimum efficiency is achieved or until an aerosol mass of at least 200 ±5 mg has contacted the filter. For PAPR100-P series filters, if the filter efficiency is decreasing when the 200 ±5 mg challenge point is reached, the test will be continued until there is no further decrease in efficiency.

(f) The efficiency of the filter will be monitored and recorded throughout the test period by a suitable forward-light scattering photometer or equivalent instrumentation.

(g) The minimum efficiency for each of the 20 filters will be determined and recorded and must be equal to or greater than the filter efficiency criterion for PAPR100-N and PAPR100-P, efficiency ≥99.97 percent, pursuant to § 84.170(b).

(a) Powered air-purifying respirators must be designed to allow for proper communication while worn.

(b) A Modified Rhyme Test^[7] will be used to test the wearer's ability to communicate efficiently.

(c) The communications requirement is met if the overall performance rating is greater than or equal to 70 percent.

(a) Chemical cartridge respirators including all completely assembled respirators which are designed for use as respiratory protection during entry into or escape from atmospheres not immediately dangerous to life and health, are described according to the specific gases or vapors against which they are designed to provide respiratory protection, as follows:

(b) Chemical cartridge respirators for respiratory protection against gases or vapors, which are not specifically listed with their maximum use concentration, may be approved if the applicant submits a request for such approval, in writing, to the Institute. The Institute shall consider each such application and accept or reject the application after a review of the effects on the wearer's health and safety and in the light of any field experience in use of chemical cartridge respirators as protection against such hazards.

(a) Each chemical cartridge respirator described in § 84.190 shall, where its design requires, contain the following component parts:

(b) The components of each chemical cartridge respirator shall meet the minimum construction requirements set forth in subpart G of this part.

(a) Particulate matter filters used in conjunction with a chemical cartridge shall be located on the inlet side of the cartridge.

(b) Filters shall be incorporated in or firmly attached to the cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement on the cartridge.

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:

(b) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.

(c) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight fit.

(d) Full facepieces shall provide for optional use of corrective spectacles or lenses which shall not reduce the respiratory protective qualities of the respirator.

(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.

(a) Inhalation and exhalation valves shall be provided where necessary and protected against distortion.

(b) Inhalation valves shall be designed and constructed to prevent excessive exhaled air from entering cartridges or adversely affecting canisters.

(c) Exhalation valves shall be—

(a)

(b) Mouthpieces shall be equipped where applicable, with an adjustable and replaceable harness designed and constructed to hold the mouthpiece in place.

(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a chemical cartridge respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with §§ 84.206 through 84.207.

(b) The maximum allowable resistance requirements for chemical cartridge respirators are as follows:

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.

(a) The complete chemical cartridge respirator will be fitted to the faces of persons having varying facial shapes and sizes.

(b) Where the applicant specifies a facepiece size or sizes for the respirator together with the approximate measurement of faces they are designed to fit, the Institute will provide test subjects to suit such facial measurements.

(c) Any chemical cartridge respirator part which must be removed to perform the facepiece or mouthpiece fit test shall be replaceable without special tools and without disturbing facepiece or mouthpiece fit.

(d) The facepiece or mouthpiece fit test using the positive or negative pressure recommended by the applicant and described in his instructions will be used before each test.

(e)

(a) Three respirators with cartridges containing, or having attached to them, filters for protection against particulates will be tested in accordance with the provisions of § 84.207.

(b) In addition to the test requirements set forth in paragraph (a) of this section, three such respirators will be tested, as appropriate, in accordance with the provisions of §§ 84.170 through 84.181; however, the maximum allowable resistance of complete particulate, and gas, vapor, or gas and vapor chemical cartridge respirators shall not exceed the maximum allowable limits set forth in § 84.203.

(a) Bench tests will be made on an apparatus that allows the test atmosphere at 50 ±5 percent relative humidity and room temperature, approximately 25 °C, to enter the cartridges continuously at predetermined concentrations and rates of flow, and that has means for determining the test life of the cartridges.

(b) Where two cartridges are used in parallel on a chemical cartridge respirator, the bench test will be performed with the cartridges arranged in parallel, and the test requirements will apply to the combination rather than to the individual cartridges.

(c) Three cartridges or pairs of cartridges will be removed from containers and tested as received from the applicant.

(d) Two air purifying cartridges or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the flow rate of 25 liters per minute (l.p.m.) for 6 hours.

(e) Two air purifying cartridges or pairs of cartridges will be equilibrated by passing 85 percent relative humidity air through them at the flow rate of 25 l.p.m.

(f) All cartridges will be resealed, kept in an upright position, at room temperatures, and tested within 18 hours.

(g) Cartridges will be tested and shall meet the minimum requirements set forth in Table 11 of this subpart.

(h) Powered air-purifying respirators with a cartridge(s) and particulate filter(s) must meet the as-received minimum service-life requirements and half of the equilibrated minimum service-life requirements set forth in table 11 of subpart L using the flows specified in subpart K, § 84.175(b) and equilibrated in accordance with paragraphs (a) through (g) of this section using the flows specified in subpart K, § 84.175(b).

(a) Front-mounted or back-mounted gas masks;

(b) Chin-style gas masks;

(c) Chemical-cartridge respirators;

(d) Powered air-purifying respirators; and

(e) Other devices, including combination respirators.

(a) Each vinyl chloride respirator described in § 84.250 shall, where its design requires, contain the following component parts:

(b) The components of each vinyl chloride respirator shall meet the minimum construction requirements set forth in Subpart G of this part.

(a) Except for the tests prescribed in § 84.126, the minimum requirements and performance tests for gas masks, prescribed in Subpart I of this part, are applicable to vinyl chloride gas masks.

(b) The following bench tests are applicable to canisters designed for use with gas masks for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:

(c) Where canisters are submitted for testing and approval with a service life of more than four hours, the period of time for testing for vinyl chloride penetration will be performed at 150% of the service life specified in the manufacturer's application. (Example: If a manufacturer requests approval of a respirator for six hours use against exposure to vinyl chloride, the maximum allowable penetration after nine hours of testing shall not exceed 1 ppm vinyl chloride.)

(a) Except for the tests prescribed in §§ 84.206 and 84.207, the minimum requirements and performance tests for chemical-cartridge respirators prescribed in Subpart L of this part are applicable to replaceable-cartridge and single-use vinyl chloride chemical-cartridge respirators.

(b) The following bench tests are applicable to cartridges designed for use with chemical-cartridge respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:

(a) Except for the tests prescribed in § 84.207, the minimum requirements and performance tests for powered air-purifying respirators prescribed in subpart L of this part are applicable to vinyl chloride powered air-purifying respirators.

(b) The following bench tests are applicable to cartridges designed for use with powered air-purifying respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:

(a) Each canister or cartridge submitted for testing and approval in accordance with §§ 84.252, 84.253, and 84.254 shall be equipped with a canister or cartridge end-of-service-life indicator which shows a satisfactory indicator change or other obvious warning before 1 ppm vinyl chloride penetration occurs. The indicator shall show such change or afford such warning at 80 ±10 percent of the total service life to 1 ppm leakage, as determined by continuing each test described in §§ 84.252(b), 84.253(b), and 84.254(b) until a 1 ppm leakage of vinyl chloride occurs.

(b) The applicant shall provide sufficient pretest data to verify the performance of the end-of-service-life indicator required in paragraph (a) of this section.

(a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs (b), (c), and (d) of this section apply to approval of gas masks, chemical cartridge respirators, and powered air-purifying respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life.

(b) The respirators submitted for approval as described in paragraph (a) of this section shall be accompanied by a complete quality control plan meeting the requirements of subpart E of this part.

(c)

(d) Final performance quality control tests on the complete canisters and cartridges shall be accomplished using the bench tests and procedures prescribed in §§ 84.252, 84.253, 84.254, and 84.255.

(a) A warning shall be placed on the label of each gas mask, chemical-cartridge respirator, and powered air-purifying respirator, and on the label of each canister and cartridge, alerting the wearer to the need for a fitting test in accordance with the manufacturer's facepiece fitting instructions, providing service life information, providing specific instructions for disposal, and advising that the wearer may communicate to NIOSH any difficulties that may be experienced in the design and performance of any gas mask, chemical-cartridge respirator, or powered air-purifying respirator approved under the requirements of this subpart. The service lives of respirators meeting the test requirements of this subpart shall be specified as follows:

Chemical-cartridge respirator1 hour.

Gas mask4 hours.

Powered air-purifying respirator4 hours.

(b) Where the service life of a respirator is approved for more than four hours, the service life for which the respirator has been approved will be specified.

(a) Any CCER approval issued after April 9, 2012 must comply with the technical requirements of subpart O.

(b) The continued manufacturing, labeling, and sale of closed-circuit apparatus previously approved under subpart H is authorized for units required for use in underground coal mines pursuant to 30 CFR 75.1714-1.

(c) Any manufacturer-requested modification to a device approved under the subpart H technical requirements must comply with the subpart H technical requirements and address an identified worker safety or health concern to be granted an extension of the NIOSH approval. Major modifications to the configuration that will result in a new approval must meet and be issued approvals under the requirements of this subpart O.

(a) Each CCER must include components and/or attributes appropriate to its design, as follows:

(b) Where an indicator is required, the indication of the occurrence of the monitored condition must be clear and unambiguous: It must not depend on a subjective interpretation of subtle, graduated, or other non-discrete changes to the indicator.

(c) Where an indicator is required, the manufacturer shall provide NIOSH with an explanation of its function and operation, and shall provide relevant data and equipment to allow NIOSH to conduct a thorough evaluation of its accuracy and reliability.

(d) The components of each CCER must meet the general construction requirements specified in § 84.61.

(e) The CCER must be resistant to the permeation of the breathing circuit by gasoline vapors. To verify such resistance, NIOSH will test one unit by applying the gasoline vapor permeation test specified on the NIOSH Web site at http://www.cdc.gov/niosh/npptl, using a breathing machine applying a ventilation rate of 40 liters per minute, performing the test for the longest duration achieved by any of the units that underwent the capacity testing specified under § 84.304.

(f) Exposed parts of the CCER must not be composed of metals or other materials that could, upon impact, create frictional sparks or that could store or generate static electrical charges of sufficient energy to ignite flammable gaseous mixtures.

(g) The design, construction, or materials of the CCER must not constitute a hazard to the user as a result of the wearing, inspection, or use of the CCER.

(h) CCER instructions and a service life plan must be provided to purchasers. This document must be clearly written.

(i) Each individual CCER unit approval label shall identify the capacity rating and number of liters of oxygen as determined by the capacity testing, pursuant to § 84.304.

(a) NIOSH will conduct capacity and performance tests on the CCER using a breathing and metabolic simulator to provide quantitative evaluations and human subjects on a treadmill to provide qualitative evaluations. Information on the design and operation of the simulator is available from the NIOSH Web site at http://www.cdc.gov/niosh/npptl. Technical specifications can be obtained from NIOSH by contacting the National Personal Protective Technology Laboratory (NPPTL) by mail: P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. Telephone: 412-386-4000 (this is not a toll-free number). Email: npptl@cdc.gov.

(b) Capacity, performance, and wearability tests will continuously monitor the stressors listed in Table 1. The stressors and their respective acceptable ranges will be measured at the interface between the CCER and the mouth by instruments capable of breath-by-breath measurement. Stressor measurements will be evaluated as 1-minute averages. The operating averages of each stressor will be calculated upon the completion of each test as the average of the 1-minute measurements of the stressor recorded during the test. The level of any excursion for a stressor occurring during a test will be defined by the 1-minute average value(s) of the excursion(s).

(c) Capacity and performance tests will conclude when the stored breathing gas supply has been fully expended.

(d) NIOSH will determine a CCER to have failed a capacity, performance, or wearability test if any of the following occurs:

(e) Unless otherwise stated, tests required under this subpart will be conducted at the following ambient conditions:

(a) NIOSH will conduct the capacity test on a total of 8 to 10 of the units submitted for approval, as follows:

(b) The capacity test will begin upon the first inhalation from or exhalation into the unit.

(c) Each unit will be tested at a constant work rate, depending on the capacity value specified by the manufacturer, according to the requirements specified in Table 2. All volumes are given at standard temperature (0 C) and pressure (760 mm Hg), dry, unless otherwise noted.

(d) NIOSH will rate an approved CCER using the appropriate capacity rating, as specified in Table 2.

(e) NIOSH will document the least value achieved by the seven units tested using the breathing and metabolic simulator. NIOSH will quantify this value of achieved capacity within an increment of 5 liters, rounding intermediate values to the nearest lower 5-liter increment.

(a) NIOSH will conduct the performance test on a total of six of the units submitted for approval, as follows:

(b) Except as provided under paragraph (c) of this section, the performance test will apply a repeating cycle of work rates, according to the sequence and requirements specified in Table 3, until the oxygen supply of the unit is exhausted.

(c) Testing of CCERs with less than 50 liters of capacity, as determined by the capacity testing under § 84.304, will require the submission of additional test units to fully apply the work-rate test sequence and requirements specified in Table 3. The testing of each individual unit will complete the cycle specified in Table 3 until the breathing supply of the initial test unit is exhausted. This initial test unit will then be replaced by a second unit, which will continue the test cycle, beginning at the work rate in the cycle at which the initial unit was exhausted, and completing the full period specified in Table 3 for that work rate before proceeding to the subsequent work rate, if any, specified in Table 3. Each initial testing unit will be replaced as many times as necessary to complete the cycle, not to exceed two replacement units per initial test unit.

(d) The performance test will begin with two exhalations into the unit at the specified ventilation rate and then follow the manufacturer's instructions to determine the design's susceptibility to hypoxia upon initial donning.

(a) NIOSH will conduct the wearability test on a total of three of the units submitted for approval. Three human subjects (two males and one female), one subject per unit, will conduct the test. The three subjects will range in height and weight as follows: One subject of height ≥174 cm and weight ≥90 kg; one subject of either 163 cm ≤height <174 cm, regardless of weight, or 72 kg ≥weight <90 kg, regardless of height; and one subject of height <163 cm and weight <72 kg. All units tested must meet all conditions specified in this section to receive approval.

(b) NIOSH will evaluate the ease and speed with which users can don the CCER, as follows:

(c) NIOSH will continuously monitor CCER use by each test subject during the activities specified in Table 4 to evaluate the ability of the CCER to provide an adequate and uninterrupted breathing supply, including but not limited to the requirements of § 84.303(b), without harming or hindering a user. NIOSH will not approve a CCER if the use of any unit during these activities indicates any potential for the CCER to harm or hinder the user or to fail to provide an adequate and uninterrupted breathing supply to the user during reasonably anticipated conditions and activities of an escape.

(a) Four units submitted for approval will be tested for capacity and performance, pursuant to the requirements of §§ 84.303 through 84.305, after exposure to environmental treatments simulating extreme storage temperatures, shock, and vibration.

(b) The units will be stored for 16 hours at a temperature of −45 °C and for 48 hours at a temperature of 71 °C. Units will be returned to room temperature between high and low temperature treatments. The maximum rate of change for thermal loading shall not exceed 3 °C per minute and constant temperatures shall be maintained within ±2 °C.

(c) The units, in the casing in which they are deployed for individual use, will be subjected to physical shock according to the following procedure:

(d) The units will be subjected to vibration according to the following procedure:

(a) NIOSH will conduct additional tests, as indicated below, on one or more of the units submitted for approval. Each unit tested must meet the conditions specified in these tests for the CCER to receive approval.

(b) NIOSH will perform safety hazard tests on any CCER that stores more than 200 liters of oxygen or that stores compressed oxygen at pressures exceeding 3,000 psi. The applicant must submit 15 units in addition to the 21-23 units required for testing under §§ 84.304 through 84.307. These units will be evaluated for fire and explosion hazards using the tests specified in RI 9333, pages 4-18; RI 8890, pages 6-62; and PRC Report No. 4294, pages 18-62.

(c) NIOSH will perform the following tests on the eye protection (gas-tight goggles or escape hood lens) of one or more units of every CCER submitted for approval:

(d) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR Part 51. All approved material is available for inspection at NIOSH, National Personal Protection Technology Laboratory (NPPTL), Bruceton Research Center, 626 Cochrans Mill Road, Pittsburgh, PA 15236. To arrange for an inspection at NIOSH, call 412-386-6111. Copies are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(a) NIOSH will conduct additional testing of the CCERs that are designed to allow the user to resupply the oxygen source and the carbon dioxide scrubber while using the respirator during an escape.

(b) NIOSH will designate CCERs that pass the tests specified in this section as “Dockable.”

(c) NIOSH will assign the capacity rating to the dockable CCER, as specified under § 84.304(d), by conducting the capacity testing using only the breathing gas supply included for the initial use of the wearable apparatus.

(d) NIOSH will test the supplemental capacities of all breathing gas resupply units produced by the manufacturer for use with the dockable CCER. Such tests will follow procedures consistent with those specified under § 84.304, including the rating requirements in § 84.304(d). The manufacturer must label the breathing gas resupply unit to indicate its capacity as tested by NIOSH and its compatibility with the CCER for which it is designed.

(e) NIOSH may require the applicant to provide additional units of the CCER and breathing gas resupply units to conduct the testing specified in this section.

(f) NIOSH will not approve a CCER with docking components, with or without the “Dockable” NIOSH designation, unless it satisfies the testing and other requirements of this section.

(a) NIOSH will periodically test the capacity and performance of units of approved CCERs.

(b) NIOSH may test units that are new and/or units that have been deployed in the field and have remaining service life.

(c) NIOSH will conduct such testing pursuant to the methods specified in §§ 84.303 through 84.305, except as provided under paragraphs (c)(1) and (2) of this section:

(d) Failure of a unit to meet the capacity and performance requirements of this section may result in revocation of the approval for the CCER or in requirements for specific remedial actions to address the cause or causes of the failure.

(e) NIOSH will replace deployed units obtained for testing with new NIOSH-approved units of the same or similar design, at no cost to the employer.

(f) To maintain the approved status of a CCER, an applicant must make available for purchase by NIOSH, within 3 months of a NIOSH purchase request, the number of units requested by the Institute. Within any 12-month period, NIOSH will not request to purchase more than 100 units for post-approval testing.

(a) The user instructions will include a copy of procedures for registering the units with NIOSH. The applicant can obtain a copy of these procedures from the NIOSH web page: http://www.cdc.gov/niosh/npptl.

(b) The applicant shall notify in writing each purchaser of the purpose of registering a unit with NIOSH, as specified under paragraph (c) of this section. If the purchaser is a distributor of the CCER, the applicant must request in writing that the distributor voluntarily notify in writing each of its purchasers of the purpose of registering a unit with NIOSH, as specified under paragraph (c) of this section.

(c) “The National Institute for Occupational Safety and Health (NIOSH) requests, but does not require, that purchasers of this respirator register each unit with NIOSH. Registration will enable NIOSH, which approved this model of respirator, to attempt to notify you if a problem is discovered that might affect the safety or performance of this respirator. Registration will also assist NIOSH in locating deployed units to periodically evaluate whether this respirator model is remaining effective under field conditions of storage and use.”