{"data":{"id":"us/21-cfr-898.12","jurisdiction":"us","citation":"21 CFR 898.12","heading":"Performance standard.","body":"(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:\nInternational Electrotechnical Commission (IEC)\n601-1: Medical Electrical Equipment\n601-1 (1988) Part 1: General requirements for safety\nAmendment No. 1 (1991)\nAmendment No. 2 (1995).\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"d358b5e2b8dd2d8011bbfa48d50b5bacb9172c222b9fccb3a36d314c447a7842","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-898.11","next":"us/21-cfr-898.13"},"notice":"GroundRules: Original legal text. Not legal advice."}