Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents. NOTE 1 Analysis and management of risk is described in ISO 22442-1. Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of transmissible spongiform encephalopathy. Selective sourcing is extremely important (see ISO 22442-1 and ISO 22442-2). NOTE 2 ISO 11135, ISO 11137, ISO 11737-1, ISO 13408, ISO 14160, ISO 14937 and ISO 17665 may be relevant for bacteria, moulds and yeast (see Bibliography). This part of ISO 22442 does not cover the utilization of human tissues in medical devices. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. NOTE 3 It is not a requirement of this part of ISO 22442 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 part of ISO 22442 can form part of a quality management system conforming to ISO 13485. This part of ISO 22442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.