• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 19-26
IEC 62485-2 Edition 1.0 2010-06
Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
This part of the IEC 62485 applies to stationary secondary batteries and battery installations with a maximum voltage of DC 1 500 V (nominal) and describes the principal measures for
protections against hazards generated from:
- electricity,
- gas emission,
- electrolyte.

This International Standard provides requirements on safety aspects associated with the erection, use, inspection, maintenance and disposal.
It covers lead-acid and NiCd / NiMH batteries.
Examples for the main applications are:
- telecommunications,
- power station operation,
- central emergency lighting and alarm systems,
- uninterruptible power supplies,
- stationary engine starting,
- photovoltaic systems
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
 Hamed Ghods
 Iacovos Kyprianou
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.