UNE-EN ISO 22442-2:2022

This document specifies requirements for controls on the sourcing, collection, and handling (whichincludes storage and transport) of animals and tissues for the manufacture of medical devices utilizingmaterials of animal origin other than in vitro diagnostic medical devices. It applies where required bythe risk management process as described in ISO/DIS 22442-1.NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiformencephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originatingfrom 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 towardsviral and bacterial loads (see also 5.5). The manufacturers should refer to ISO 22442-3 for informationon 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 productionof 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. Attentionis drawn to the standards for quality management systems (see ISO 13485) that control all stages ofproduction or reprocessing of medical devices. The quality management system elements that arerequired 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 dueconsideration to the requirements and recommendations contained in all three parts of the standard.