Justify Animal Testing

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4.2 Justification for animal tests

When required to make proper provision to ensure human safety, animal testing to enable the proper biological characterization of materials used in medical devices is acceptable.

For the purposes of the ISO 10993 series, animal tests shall only be deemed to be justified when:

the resulting data are not otherwise available, but are essential to properly characterize the test material in the context in which it is to be used;

when no suitable scientifically validated test method not involving the use of living animals is reasonably and practically available;

when relevant reduction and refinement strategies have been identified and implemented including, if appropriate, obtaining test data from manufacturers
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As stated in 4.2, animal testing shall only be undertaken when the information required is essential to characterize the test material, is not otherwise available and when no suitable scientifically validated test method not involving the use of living animals is reasonably and practically available.

Following consideration of relevant and reasonably available potential replacement, reduction and refinement strategies, and before animal tests are undertaken, principal investigators and/or sponsors shall attest and document that no other replacement, reduction, or refinement strategies are required to minimize the animal welfare costs of the studies.
Where the provisions of the ISO 10993 series of International Standards require or permit that an informed choice be made from a range of species, stages of development or animal numbers for an animal test, the decisions taken shall both safeguard the scientific validity of the test and minimize any pain, suffering, distress, or lasting harm to the animals used. The rationale for the decisions taken shall be
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When purpose-bred animals are not used, the justification and details of the provenance of the animals that are used shall be documented.

High standards of care and accommodation enhance the welfare of the animals used and promote the scientific validity of animal testing. Animal care and accommodation shall demonstrably, as a minimum, conform to relevant, published national or international animal care, accommodation and husbandry guidelines.

The relevant guidelines or requirements shall be referenced, and evidence of compliance (or details of non-compliance accompanied by an assessment of its likely impact on the welfare of the animals used and the validity of the data obtained) shall be explained, justified, and documented.

Any component of the husbandry system that does not make best provision for the welfare of the test animals, might compromise the scientific validity of the test, or inappropriately influence the nature or interpretation of the test result, shall be documented.

Social species shall be housed as stable, compatible pairs or groups unless single-housing is required for veterinary, husbandry, animal welfare, or scientific

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