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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 19-27
Standard
IEC  62485-3 Edition 2.0 2014-07
Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
Scope/Abstract
This part of the IEC 62485 applies to secondary batteries and battery installations used for electric vehicles, e.g. in electric industrial trucks (including lift trucks, tow trucks, cleaning machines, automatic guided vehicles), in battery powered locomotives, in electric vehicles (e.g. goods vehicles, golf carts, bicycles, wheelchairs), and does not cover the design of such vehicles.

This International Standard covers lead dioxide-lead (lead-acid), nickel oxide-cadmium, nickeloxide-metal hydride and other alkaline secondary batteries. Safety aspects of secondary lithium
batteries in such applications will be covered in their own appropriate standards.

The nominal voltages are limited to 1000 V a.c. and 1500 V d.c. respectively and the principal measures for protection against hazards generally from electricity, gas emission and electrolyte are described.

It provides requirements on safety aspects associated with the installation, use, inspection,
maintenance and disposal of batteries.
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
 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)
*These are provided as examples and others may be applicable.
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