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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 044 Date of Entry 07/26/2016 
FR Recognition Number 2-228
Standard
ISO 10993-3 Third edition 2014-10-1
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
U.S. Identical Adoption
ANSI AAMI ISO 10993-3:2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
Scope/Abstract
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:

- genotoxicity;

- carcinogenicity;

- reproductive and developmental toxicity.

This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

NOTE Guidance on selection of tests is provided in ISO 10993-1.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 4.1.
Clause 5.2.3
Clause 5.3.
Clause 6.2, Sentence, "One animal species is typically sufficient for testing medical devices."
Clause 7.2, Phrase, "or test material"
Annexes A and B
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12 2012 Biological evaluation of medical devices-Part 12: Sample preparation and reference materials.

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 June 16 2016. Updated September 2020.
FDA Technical Contacts
 Ramesh K. Panguluri
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6303
  ramesh.panguluri@fda.hhs.gov
 Rosalie Elespuru
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-0237
  rosalie.elespuru@fda.hhs.gov
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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