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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 19-25
Standard
IEC 62485-1 Edition 1.0 2015-04
Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
Scope/Abstract
This Part of IEC 62485 specifies the basic requirements for secondary batteries and battery installations.

The requirements regarding safety, reliability, life expectancy, mechanical strength, cycle stability, internal resistance, and battery temperature, are determined by various applications,
and this, in turn, determines the selection of the battery design and technology.

In general, the requirements and definitions are specified for lead-acid and nickel-cadmium batteries. For other battery systems with aqueous electrolyte, the requirements may be
applied accordingly.

The standard covers safety aspects taking into account hazards associated with:
- electricity (installation, charging, discharging, etc.);
- electrolyte;
- inflammable gas mixtures;
- storage and transportation.
With respect to electrical safety, reference is made to IEC 60364-4-41.
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.
FDA Technical Contacts
 Charles Ho
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6320
  charles.ho@fda.hhs.gov
 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)
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