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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 047 Date of Entry 08/21/2017 
FR Recognition Number 19-28
Standard
IEC 62485-4 Edition 1.0 2015-01
Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
Scope/Abstract
This Part of IEC 62485 applies to the safety aspects associated with the accommodation, the arrangements of circuits and the operation of secondary valve-regulated lead-acid cells and
batteries in portable appliances. Requirements are specified which oblige the manufacturers of appliances and secondary batteries to prevent the misuse of batteries in the course of
operation to provide protective measures avoiding injury to persons in case of battery failure and to provide sufficient information to users.

This standard does not apply to secondary cells and batteries containing alkaline or other non-acid electrolytes.
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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