| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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2-289
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| Standard | (Included in ASCA) |
ISO 10993-12 Fifth edition 2021-01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
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Scope/AbstractThis document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
- test sample selection;
- selection of representative portions from a medical device;
- test sample preparation;
- experimental controls;
- selection of, and requirements for, reference materials;
- preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant. |
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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| FDA recognition of ISO 10993-12 Fourth edition 2012-07-01 [Rec# 2-191] will be superseded by recognition of ISO 10993-12 Fifth edition 2021-01 [Rec# 2-289]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-191] until December 22, 2024. After this transition period, declarations of conformity to [Rec# 2-191] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.
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. |
