Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

053

Date of Entry 12/23/2019 

FR Recognition Number

19-33

Standard

IEC  62133-2 Edition1.0 2017-02
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 - Part 2: Lithium systems

Scope/Abstract

This part of IEC 62133 specifies requirements and tests for the safe operation of portable sealed secondary lithium cells and batteries containing non-acid electrolyte, under intended use and reasonably foreseeable misuse.

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 http://www.iec.ch/

FDA Specialty Task Group (STG)

General II (ES/EMC)

*These are provided as examples and others may be applicable.