part_subject: "PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES"
subpart_code: "B"
subpart_subject: "Requirements for Specific Medical Devices"
section_number: "898.12"
section_subject: "Performance standard."
cfr_reference: "21 CFR 898.12"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.