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Electronic Code of Federal Regulations

e-CFR Data is current as of November 24, 2014

Title 42Chapter ISubchapter GPart 84 → Subpart O


Title 42: Public Health
PART 84—APPROVAL OF RESPIRATORY PROTECTIVE DEVICES


Subpart O—Closed-Circuit Escape Respirators


Contents
§84.300   Closed-circuit escape respirator; description.
§84.301   Applicability to new and previously approved CCERs.
§84.302   Required components, attributes, and instructions.
§84.303   General testing conditions and requirements.
§84.304   Capacity test requirements.
§84.305   Performance test requirements.
§84.306   Wearability test requirements.
§84.307   Environmental treatments.
§84.308   Additional testing.
§84.309   Additional testing and requirements for dockable CCERs.
§84.310   Post-approval testing.
§84.311   Registration of CCER units upon purchase.

Source: 77 FR 14193, Mar. 8, 2012, unless otherwise noted.

§84.300   Closed-circuit escape respirator; description.

The closed-circuit escape respirator (CCER), technically a subset of self-contained breathing apparatus (SCBAs) which are otherwise covered under subpart H of this part, is used in certain industrial and other work settings in emergencies to enable users to escape from atmospheres that can be immediately dangerous to life and health. Known in the mining community as self-contained self-rescuers (SCSRs), and in other industries as emergency escape breathing devices (EEBDs) or apparatus (EEBAs), CCERs are relied upon primarily by underground coal miners, sailors in federal service, and railroad workers to escape dangerous atmospheres after a fire, explosion, or chemical release. CCERs are commonly worn on workers' belts or stored in close proximity to be accessible in an emergency. They are relatively small respirators, typically the size of a water canteen, that employ either compressed oxygen with a chemical system for removing exhaled carbon dioxide from the breathing circuit, or a chemical that both provides a source of oxygen and removes exhaled carbon dioxide. Users re-breathe their exhalations after the oxygen and carbon dioxide levels have been restored to suitable levels, which distinguishes these “closed-circuit” self-contained respirators from “open-circuit” self-contained respirators, which vent each exhalation.

§84.301   Applicability to new and previously approved CCERs.

This subpart applies to the following CCERs:

(a) All CCERs submitted to NIOSH for a certificate of approval after April 9, 2012; and

(b) All CCERs manufactured and labeled NIOSH-approved and sold by manufacturers after April 9, 2015.

§84.302   Required components, attributes, and instructions.

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

(1) Eye protection: Each CCER must include safety goggles or an escape hood lens that protects against impact, fogging, and permeation by gas, vapor, and smoke, as specified under §84.308(c);

(2) Thermal exposure indicators: If the manufacturer specifies a maximum and/or minimum environmental temperature limit for storage of the CCER, then the CCER must include a component, an attribute, or other means by which a person can determine whether the CCER has been exposed to temperatures that exceed the limit(s);

(3) Chemical bed physical integrity indicators: If the CCER includes a chemical oxygen storage or chemical carbon dioxide scrubber that can be functionally damaged by impact, vibration, or any other environmental factor to which the CCER might be exposed, then the CCER must include a component, an attribute, or other means by which a person can detect any damage or alteration of the chemical oxygen storage or chemical carbon dioxide scrubber that could diminish the NIOSH-certified performance of the CCER, as tested under this subpart;

(4) Oxygen storage vessel: If the CCER includes an oxygen storage vessel, the vessel must be approved by the U.S. Department of Transportation (DOT) under 49 CFR part 107, “Hazardous Materials Program Procedures,” unless exempted under subpart B of 49 CFR part 107;

(5) Tamper-resistant/tamper-evident casing: If the CCER is not designed for its casing to be opened prior to use for an actual escape (e.g., for maintenance, escape drills, or inspection of the components), the casing must include a component, an attribute, or other means to prevent a person from accidentally opening the casing and, upon such opening, to either prevent the casing from being closed or to clearly indicate to a potential user that the casing has been previously opened; and

(6) Moisture damage indicators: If the CCER is not designed for its casing to be opened for inspection of its internal components, the casing must include a component, an attribute, or other means by which a person can detect any ingress of water or water vapor that could diminish the NIOSH-certified performance, as tested under this subpart.

(7) Oxygen starter indicators: If the oxygen starter is a critical component of the CCER design, then the CCER must include a component, an attribute, or other means by which a person can detect observable damage, premature activation, or recognized potential defect of the starter.

(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.

(1) Instructions must address the following topics and elements:

(i) An explanation of how the CCER works;

(ii) A schematic diagram of the CCER;

(iii) Procedures for donning and use;

(iv) Procedures for inspecting the operating condition of the CCER;

(v) Procedures and conditions for storage, including but not limited to any recommended minimum and maximum temperatures for storage;

(vi) Limitations on use, including but not limited to any recommended minimum and maximum temperatures for use;

(vii) Procedures for disposal; and

(viii) Procedures for registration of the unit with NIOSH, pursuant to §84.311.

(2) The service life must be addressed covering at least the following topics:

(i) The maximum number of years, from the date of manufacture, that the unit may remain available for use; this limit is intended to prevent the continued use of a unit that the applicant cannot assure would continue to perform as approved by NIOSH, due to reasonably foreseeable degradation of materials used in its construction;

(ii) Any other conditions, other than that specified under paragraph (h)(2)(i) of this section, that should govern the removal from service of the CCER (including an indication given by the activation or operation of any required indicator showing the monitored condition has occurred); and

(iii) Any procedures by which a user or others should inspect the CCER, perform any maintenance possible and necessary, and determine when the CCER should be removed from service.

(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.

§84.303   General testing conditions and requirements.

(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).

Table 1—Monitored Stressors and Their Acceptable Ranges

StressorAcceptable range operating averageAcceptable range excursion
Average inhaled CO2<1.5%≤4%.
Average inhaled O2>19.5%≥15%.
Peak Breathing PressuresΔP ≤200 mm H2O−300 ≤ΔP ≤200 mm H2O.
Wet-bulb temperature1<43 °C≤50 °C.

1Wet-bulb temperature is a measurement of the temperature of a wet surface. It represents the temperature of the inhaled breathing gas in the CCER user's trachea.

(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:

(1) A 1-minute average measurement of any stressor listed in Table 1 occurs outside the acceptable excursion range specified in Table 1; or an average stressor measurement calculated at the completion of a performance or capacity test exceeds the acceptable operating average range specified in Table 1; or

(2) A human subject cannot complete the test for any reason related to the CCER, as determined by NIOSH.

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

(1) Ambient temperatures of 23 °C ±3 °C; and

(2) Atmospheric pressures of 735 mm Hg ±15 mm Hg.

§84.304   Capacity test requirements.

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

(1) Three units will be tested on a breathing and metabolic simulator in the condition in which they are received from the applicant;

(2) Two units will be tested on a breathing and metabolic simulator after being subjected to the environmental treatments specified in §84.307 of this subpart;

(3) Two units will be tested on a breathing and metabolic simulator at the cold-temperature limit recommended by the manufacturer under §84.302(h)(1), after the unit has been stored for a minimum of 24 hours at this limit; and

(4) One unit, in the condition in which it is received from the applicant, will be tested by a human subject on a treadmill.

(5) To approve a CCER for use in coal mines, two units will also be tested by a human subject under the specifications of §§84.99 and 84.100 that are applicable to man test 4.

(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.

Table 2—Capacity Test Requirements

Capacity ratingCapacity
(L of O2)
VO2
(L/min)
VCO2
(L/min)
Ve
(L/min)
RF (Breaths/min)
Cap 120 ≤L ≤592.502.505522
Cap 260 ≤L ≤792.001.804420
Cap 3L ≥801.351.153018

VO2 = volume of oxygen consumed per minute; VCO 2 = volume of carbon dioxide produced per minute.

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

(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.

§84.305   Performance test requirements.

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

(1) Three units will be tested on a breathing and metabolic simulator in the condition in which they were received from the applicant; and

(2) Two units will be tested on a breathing and metabolic simulator after being subjected to the environmental treatments specified in §84.307; and

(3) One unit will be tested, in the condition in which it was received from the applicant, by a human subject on a treadmill.

(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.

Table 3—Performance Test Requirements

Work-rate
test sequence
Duration per cycle (in minutes)VO2 (L/min)VCO2 (L/min)Ve (L/min)RF (breaths/min)
1. Peak53.003.2065.025
2. High152.001.8044.020
3. Low100.500.4020.012

VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.

Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

§84.306   Wearability test requirements.

(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:

(1) Each test subject will be provided with manufacturer instructions, and must be able to don the CCER correctly, isolating the lungs within 30 seconds;1 and

1This time limit does not apply to any additional steps that might be required after the lungs are protected to adjust the unit for wear.

(2) A CCER must not include any design, construction, or material characteristic that can be anticipated or demonstrated, under plausible conditions, to hinder the user in the correct and timely donning of the CCER.

(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.

Table 4—Wearability Test Requirements

ActivityMinimum duration
Sitting1 minute.
Stooped walking1 minute.
Crawling1 minute.
Lying on left side1 minute.
Lying on right side1 minute.
Lying on back1 minute.
Bending over to touch toes1 minute.
Turning head from side to side1 minute (at least 10 times).
Nodding head up and down1 minute (at least 10 times).
Climbing steps or a laddermill1 minute (1 step/second).
Carrying 50-lb bag on treadmill at 5 kph1 minute.
Lifting 20-lb weight from floor to an upright position1 minute (at least 10 times).
Running on treadmill at 10 kph1 minute.

§84.307   Environmental treatments.

(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:

(1) The unit will be dropped six times from a height of 1 meter onto a concrete surface; and

(2) Each drop will test a different orientation of the unit, with two drops along each of its three major axes (top to bottom, left to right, and front to back).

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

(1) The unit will be firmly secured to a shaker table, which will be vibrated with motion applied along a single axis for 180 minutes;

(2) The unit will be vibrated one axis at a time along each of three axes for a total of 9 hours; and

(3) The vibration frequency regimen applied to each axis will be cyclical, repeating the sequence and specifications provided in Table 5 every 20 minutes.

Table 5—Vibration Test Sequence

SequenceFrequency (Hertz)Acceleration g (±peak)
15-922.5
292-5003.5
3500-20001.5

§84.308   Additional testing.

(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:

(1) NIOSH will test the effectiveness of the eye protection against dust using the method specified in ISO 4855-1981(E) Clause 13, Test for protection against dust. The result will be satisfactory if the reflectance after the test is equal to or greater than 80 percent of its value before testing.

(2) NIOSH will test the effectiveness of the eye protection against gas using the method specified in ISO 4855-1981(E), Clause 14, Test for protection against gas. The test must not result in staining of the area enclosed by the eye protection.

(3) NIOSH will test the durability of the eye protection using the method specified in International Standard ISO 4855-1981(E), Sub-clause 3.1, Unmounted oculars. The lens shall not crack or fracture as a result of the test.

(4) NIOSH will test the eye protection's resistance to fogging in accordance with the method specified in BS EN 168:2002, Clause 16, Test for resistance to fogging of oculars. The lens shall remain free from fogging for a minimum of 8 seconds, pursuant to Clause 16.

(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.

(1) British Standards Institute, 389 Chiswick High Road, London W4 4AL, UK, http://www.bsigroup.com/en/Standards-and-Publications:

(i) BS EN 168:2002, Personal Eye Protectors—Non-Optical Test Methods, November 2001.

(ii) [Reserved]

(2) International Organization for Standardization, 1, ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org/iso/store.htm:

(i) ISO 4855-1981(E), Personal Eye Protectors—Non-Optical Test Methods, First edition April 1, 1981.

(ii) [Reserved]

(3) U.S. Department of the Interior, Bureau of Mines, 2401 E Street, NW., MS #9800, Washington, DC 20241-0001. These reports are also available from NIOSH upon request 1-800-CDC-INFO (232-4636).

(i) Pittsburgh Research Center (PRC) Report No. 4294, Evaluation of the Safety of One-Hour Chemical Self Rescuers, July 1980;

(ii) Report of Investigations (RI) 8890, Evaluation of the Safety of One-Hour Compressed Oxygen Self-Rescuers—Results of Destructive Testing, 1984;

(iii) RI 9333 Evaluation of the Safety of the CSE SR-100 Self-Contained Self-Rescuer, 1991.

§84.309   Additional testing and requirements for dockable CCERs.

(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.

(1) NIOSH will test the docking mechanism and procedure to ensure that they maintain the integrity of the breathing circuit (against the intake of hazardous fumes or gases) and the continuity of the breathing gas supply throughout the docking process.

(2) NIOSH will test the docking mechanism and procedure to ensure that users can employ the docking process reliably, safely, and quickly under escape conditions.

(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.

§84.310   Post-approval testing.

(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 paragraph (d) of this section.

(d) The numbers of units of an approved CCER to be tested under this section may exceed the numbers of units specified for testing in §§84.304 and 84.305.

(e) 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.

(f) 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.

(g) 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.

§84.311   Registration of CCER units upon purchase.

(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.”



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