This part of ISO 10993 is aimed at those who commision, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or of the meducal devices themselves. It specifies the miniumum requirements to be satisfied to ensure and demonstrate that proper provission has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.
ANSI/AAMI/ISO 10993-2:2006 history
2006ANSI/AAMI/ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements