[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR898.12]

[Page 552]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 898_PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT
CABLES--Table of Contents
 
Sec. 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.