§ 898.12 Performance standard.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
(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:
(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.
International Electrotechnical Commission (IEC)601-1: Medical Electrical Equipment601-1 (1988) Part 1: General requirements for safetyAmendment No. 1 (1991)Amendment No. 2 (1995).
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