Date: 22/07/2014

U.S. FDA recognize two UL battery safety standards for medical devices

U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells).

Consensus standards are standards recognized by the FDA for use in evaluating medical devices before they are approved for market entry. UL states "In the case of medical devices using batteries, manufacturers can now use the proof of compliance with UL 2054 and UL 1642 as evidence of a device's safety and effectiveness."
Author: Srinivasa Reddy N