Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables
fda-device · Food and Drug Administration · Rule · Published 1997-05-09 · Effective 1997-08-07 · 62 FR 25477
Document
Document number
97-11967
Federal Register citation
62 FR 25477
CFR reference
21 CFR 898
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.