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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 2-222
Standard
ISO 10993-2 Second edition 2006-07-15
Biological Evaluation of medical devices - Part 2: Animal welfare requirements
U.S. Identical Adoption
ANSI AAMI ISO 10993-2:2006/(R)2014
Biological Evaluation of medical devices - Part 2: Animal welfare requirements
Scope/Abstract
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.

It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
Extent of Recognition
Complete standard
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.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff. General Considerations for Animal Studies for Cardiovascular Devices. 29 July 2010.

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 2016. Updated September 2020.

FDA Draft Guidance: General Considerations for Animal Studies for Medical Devices, which, when final will represent the Agency's thinking on this topic.
FDA Technical Contacts
 Judith A. Davis
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6636
  judith.davis@fda.hhs.gov
 Annabelle Crusan
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-4926
  Annabelle.Crusan@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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