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Recognized Consensus Standards

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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.
Transition Period
FDA recognition of IEC 60086-4 Edition 4.0 2014-09 [Rec# 19-23] will be superseded by recognition of IEC 60086-4 Edition 5.0 2019-04 [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)][Rec# 19-40]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 19-23] until July 10, 2022. After this transition period, declarations of conformity to [Rec # 19-23] will not be accepted.
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 http://www.iec.ch/
FDA Specialty Task Group (STG)
General II (ES/EMC)
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