Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

056

Date of Entry 06/07/2021

FR Recognition Number

19-40

Standard

IEC 60086-4 Edition 5.0 2019-04
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]

Scope/Abstract

This Part of IEC 60086 specifies tests and requirements for primary lithium batteries to ensure their safe operation under intended use and reasonably foreseeable misuse.

NOTE Primary lithium batteries that are standardized in IEC 60086-2 are expected to meet all applicable requirements herein. It is understood that consideration of this part of IEC 60086 might also be given to measuring and/or ensuring the safety of non-standardized primary lithium batteries. In either case, no claim or warranty is made that compliance or non-compliance with this standard will fulfil or not fulfil any of the user's particular purposes or needs.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Iacovos Kyprianou

FDA/OC/CDRH/OSPTI/DAHRSSP/SSPI/

301-796-2601

iacovos.kyprianou@fda.hhs.gov

Hamed Ghods

FDA/OC/CDRH/OSEL/DBP/

301-796-2656

hamed.ghods@fda.hhs.gov

Standards Development Organization

IEC

International Electrotechnical Commission