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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 19-13
Standard
IEC 62133 Edition 2.0 2012-12
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
Scope/Abstract
IEC 62133:2012 specifies requirements and tests for the safe operation of portable sealed secondary cells and batteries (other than button) containing alkaline or other non-acid electrolyte, under intended use and reasonably foreseeable misuse. This edition includes the following significant technical changes with respect to the previous edition:
- update of assembly of cells into batteries (5.5);
- addition of design recommendations for lithium system only (5.6.2);
- separation of nickel systems and lithium systems (Clause 6);
- addition of specific requirements and tests for lithium systems (Clause 8);
- addition of charging of secondary lithium-ion cells for safe use (Annex A). The contents of the corrigendum of June 2013 have been included in this copy.
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
 Hamed Ghods
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2656
  hamed.ghods@fda.hhs.gov
 Iacovos Kyprianou
  FDA/OC/CDRH/OSPTI/DAHRSSP/SSPI/
  301-796-2601
  iacovos.kyprianou@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.
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