ISO 22442-2:2020 PDF

Scope: 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 than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices.

ISO 22442-2:2020 Referenced Document

ISO 22442-1 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

2020 ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
2015 ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
2007 ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling