| 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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19-56
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| Standard | |
IEC 60086-4 Edition 6.0 2025-01
Primary batteries - Part 4: Safety of lithium batteries |
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Scope/AbstractThis Part of IEC 60086 specifies tests and requirements for primary lithium batteries to ensure their safe operation under intended use and reasonably foreseeable misuse.
NOTE Primary lithium batteries that are standardized in IEC 60086-2 are expected to meet all applicable requirements herein. It is understood that consideration of this part of IEC 60086 might also be given to measuring and/or ensuring the safety of non-standardized primary lithium batteries. In either case, no claim or warranty is made that compliance or non-compliance with this standard will fulfil or not fulfil any of the user's particular purposes or needs. |
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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| FDA recognition of IEC 60086-4 Edition 5.0 2019-04 [Rec# 19-40] will be superseded by recognition of IEC 60086-4 Edition 6.0 2025-01 [Rec# 19-56]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-40] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 19-40] 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. |
