本文件规定了对动物和组织的采购、收集和处理（包括储存和运输）进行控制的要求，这些动物和组织用于制造使用动物源性材料而非vitrodiagnostic医疗器械的医疗器械。它适用于ISO 22442-1中所述的风险管理流程要求的情况。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other thanin vitrodiagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1.All current amendments available at time of purchase are included with the purchase of this document.