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ANSI/AAMI/ISO 22442-1:2016
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
Applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. Specifies, in conjunction with ANSI/AAMI/ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ANSI/AAMI/ISO 14971, and expected medical benefit as compared to available alternatives. This part of ANSI/AAMI/ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives.
Association for the Advancement of Medical Instrumentation [aami]