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ANSI/AAMI/ISO 10993-2-2006 (R2014)

Biological evaluation of medical devices - Part 2: Animal welfare requirements

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.

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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Human factors engineering - Design of medical devices
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