| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
044
|
Date of Entry 07/26/2016
|
|
FR Recognition Number
|
2-191
|
| Standard | (Included in ASCA) |
ISO 10993-12 Fourth edition 2012-07-01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
|
Identical AdoptionANSI AAMI ISO 10993-12:2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
|
Scope/AbstractThis part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following:
- test sample selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of, and requirements, for reference materials;
- preparation of extracts.
This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 10.3.10
Annex D |
|
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.
This standard is recognized in part because:
Clause 10.3.10 and Annex D contain a test method that is in conflict with the references listed below. |
|
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| FDA recognition of ISO 10993-12 Fourth edition 2012-07-01 [Rec# 2-191] will be superseded by recognition of ISO 10993-12 Fifth edition 2021-01 [Rec# 2-289].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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
|
Relevant FDA Guidance and/or Supportive Publications*
Nakamura, et al.(2003). Evaluation of Allergic Potential of Rubber Products: Comparison of Sample Preparation Methods for the Testing of Polymeric Medical Devices. Journal of Toxicology: Cutaneous and Ocular Toxicology, 2003, Vol. 22 (3), pg 169 - 185.
Przygoda, R.T. (2017). Safety Assessment and Global Regulatory Requirements for Genetic Toxicity Evaluations of Medical Devices. Environmental and Molecular Mutagenesis, Vol. 58 (5), pp375-379.
Peng, et al. (2018). Evaluation of Sample Preparation Methods in the ISO 10993-12 Standard: problems Associated with Exhaustive Extraction of Polymeric materials for Biological Evaluation," SOT poster.
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
