標準號：ISO 22442-2-2007
中文標準名稱：醫療設備用動物組織及其衍生物.第2部分:來源控制、采集和處理
英文標準名稱：Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
標準類型：C37
發布日期：2007/12/1 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C37
國際標準分類號：11.100.20
適用范圍：This part of ISO 22442 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 by the riskmanagement process as described in ISO 22442-1.NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy(TSE) risk management.NOTE 2 Manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/orinactivation of viruses and TSE agents.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 ofproduction 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 thestandards for quality management systems (see ISO 13485) that control all stages of production or reprocessing ofmedical devices. The quality management system elements that are required by this part of ISO 22442 can form a part ofa quality management system conforming to ISO 13485.NOTE 4 A general principle for the application of ISO 22442 is that it is advisable to give due consideration to therequirements and recommendations contained in all three parts of the standard.