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e-CFR data is current as of September 18, 2020

Title 21Chapter ISubchapter HPart 898 → §898.12


Title 21: Food and Drugs
PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES


§898.12   Performance standard.

(a) Any connector in a cable or electrode lead wire having a conductive connection to a patient shall be constructed in such a manner as to comply with subclause 56.3(c) of the following standard:

International Electrotechnical Commission (IEC)

601-1: Medical Electrical Equipment

601-1 (1988) Part 1: General requirements for safety

Amendment No. 1 (1991)

Amendment No. 2 (1995).

(b) Compliance with the standard shall be determined by inspection and by applying the test requirements and test methods of subclause 56.3(c) of the standard set forth in paragraph (a) of this section.

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