| 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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19-28
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| Standard | |
IEC 62485-4 Edition 1.0 2015-01
Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances |
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Scope/AbstractThis Part of IEC 62485 applies to the safety aspects associated with the accommodation, the arrangements of circuits and the operation of secondary valve-regulated lead-acid cells and
batteries in portable appliances. Requirements are specified which oblige the manufacturers of appliances and secondary batteries to prevent the misuse of batteries in the course of
operation to provide protective measures avoiding injury to persons in case of battery failure and to provide sufficient information to users.
This standard does not apply to secondary cells and batteries containing alkaline or other non-acid electrolytes. |
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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. |
|
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. |
