| 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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19-25
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| Standard | |
IEC 62485-1 Edition 1.0 2015-04
Safety requirements for secondary batteries and battery installations - Part 1: General safety information. |
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Scope/AbstractThis 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. |
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| Extent of Recognition
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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. |
