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/DIS 22442-1. NOTE 1 - Selective sourcing is considered to be 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. In addition, local safety regulation may be applied to ensure a clean basic handling of animals towards viral and bacterial loads (see also 5.5). The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. 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. It is not a requirement of this document to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this document can form a part of a quality management system conforming to ISO 13485. NOTE 2 - A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.