---
kind: "section"
citation: "21 C.F.R. § 898.12"
title: "21"
number: "898.12"
heading: "Performance standard."
url: "https://uscodex.org/cfr/21/898.12"
---

# §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:
- (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)](#a) of this section.

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264.

### Source

Source: 62 FR 25497, May 9, 1997, unless otherwise noted.