| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
053
|
Date of Entry 12/23/2019
|
|
FR Recognition Number
|
19-13
|
| Standard | |
IEC 62133 Edition 2.0 2012-12
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)] |
|
Scope/AbstractIEC 62133:2012 specifies requirements and tests for the safe operation of portable sealed secondary cells and batteries (other than button) containing alkaline or other non-acid electrolyte, under intended use and reasonably foreseeable misuse. This edition includes the following significant technical changes with respect to the previous edition:
- update of assembly of cells into batteries (5.5);
- addition of design recommendations for lithium system only (5.6.2);
- separation of nickel systems and lithium systems (Clause 6);
- addition of specific requirements and tests for lithium systems (Clause 8);
- addition of charging of secondary lithium-ion cells for safe use (Annex A). The contents of the corrigendum of June 2013 have been included in this copy. |
|
| 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. |
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
