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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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 Adoption
ANSI AAMI ISO 10993-12:2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
This 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FDA recognition of ISO 10993-12 Fourth edition 2012-07-01 [Rec# 2-191] will be superseded by recognition of ISO 10993-12 Fifth edition 2021-01 [Rec# 2-289].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
 Chandramallika (Molly) Ghosh
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.