# Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables
> **Food and Drug Administration** · Final rule. · Published 1997-05-09 · Effective 1997-08-07 · 62 FR 25477
## Document
- **Document number:** 97-11967
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 25477
- **CFR reference:** 21 CFR 898
- **Publication date:** 1997-05-09
- **Effective date:** 1997-08-07
- **HHS docket:** Docket No. 94N-0078
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing a performance standard for electrode lead wires and patient cables. The agency is taking this action because it has determined that a performance standard is needed to prevent electrical connections between patients and electrical power sources. The final rule will substantially reduce the risk of electrocution from unprotected electrode lead wires and patient cables.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/05/09/97-11967/medical-devices-establishment-of-a-performance-standard-for-electrode-lead-wires-and-patient-cables)
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