FDA Recognizes Two UL Battery Safety Standards for Medical Devices
- Wednesday, 23 July 2014
UL (Underwriters Laboratories), Northbrook, IL, announced that the 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. The FDA's Center for Devices and Radiological Health (CDRH) believes that conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices. 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.