| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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19-54
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| Standard | |
IEC 60086-5 Edition 5.0 2021-09
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)] |
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Scope/Abstract| This part of IEC 60086 specifies tests and requirements for primary batteries with aqueous electrolyte to ensure their safe operation under intended use and reasonably foreseeable misuse. |
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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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Transition Period
| FDA recognition of IEC 60086-5 Edition 4.0 2016-07 [Rec# 19-24] will be superseded by recognition of IEC 60086-5 Edition 5.0 2021-09 [Rec# 19-54]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-24] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 19-24] will not be accepted. |
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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. |
