适用于使用动物源性材料制造的体外诊断医疗器械以外的不可行或已被证明不可行的医疗器械。结合ANSI/AAMI/ISO 14971规定了一个程序，以识别与此类设备相关的危险和危险情况，估计和评估由此产生的风险，控制这些风险，并监测控制的有效性。概述剩余风险可接受性的决策过程，考虑ANSI/AAMI/ISO 14971中定义的剩余风险平衡，以及与可用替代品相比的预期医疗效益。ANSI/AAMI/ISO 22442的本部分旨在提供与利用动物组织或衍生物制造的医疗器械的典型危害相关的风险管理要求和指南。

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.