2nd Edition, July 15, 2006
Biological evaluation of medical devices Part 2: Animal welfare requirements
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Description / 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.