BS EN ISO 10993-2:2006

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Justification for animal tests
  4.3 Competence of personnel
  4.4 Planning and performance of animal tests
  4.5 Test strategy - Sequence of in vitro and in vivo tests
  4.6 Animal care and accommodation
  4.7 Humane endpoints
  4.8 Study documentation
  4.9 Validity of test results and mutual acceptance of data
Annex A (informative) Rationale for the development of this
        part of ISO 10993
Annex B (informative) Further suggestions for replacing,
        reducing and refining animal tests
Bibliography

Defines 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.

This part of ISO10993 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.