| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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047
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Date of Entry 08/21/2017
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FR Recognition Number
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19-26
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| Standard | |
IEC 62485-2 Edition 1.0 2010-06
Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries. |
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Scope/AbstractThis 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 |
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| Extent of Recognition
|
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. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
