| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
053
|
Date of Entry 12/23/2019
|
|
FR Recognition Number
|
19-33
|
| Standard | |
IEC 62133-2 Edition1.0 2017-02
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 - Part 2: Lithium systems |
|
Scope/Abstract| This part of IEC 62133 specifies requirements and tests for the safe operation of portable sealed secondary lithium cells and batteries containing non-acid electrolyte, under intended use and reasonably foreseeable misuse. |
|
| 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. |
|
Transition Period
| FDA recognition of IEC 62133-2 Edition1.0 2017-02 [Rec# 19-33] will be superseded by recognition of IEC 62133-2 Edition 5.0 2021-09 [Rec# 19-55]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-33] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 19-33] will not be accepted. |
|
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. |
