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Biological evaluation of medical devices – Part 2: Continue shopping Proceed to checkout.
Scope This part of ISO is aimed at those who commission, design and perform tests or evaluate data from animal tests 109932- to assess the biocompatibility of materials intended for use in medical devices, or 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.
ISO – Biological evaluation of medical devices — Part 2: Animal welfare requirements
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 ido provisions relating to species, source, health status, and care and accommodation does it apply to testing kso on isolated tissues and organs taken from vertebrate animals that have been euthanised. Do not show this again. You must be logged in to sign up for monitoring You must be logged in to sign up for subscription. There is a problem adding monitoring – please try again later There is a problem adding the subscription – please try again later.
FCR – First Clinical Research Laws, Regulations & Guidelines
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