標準號：ANSI/AAMI/ISO 22442-3-2007
中文標準名稱：醫療設備用動物組織及其衍生物.第3部分:病毒和遺傳性海綿狀腦病(TSE)試劑的消滅和/或失效的確認
英文標準名稱：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
標準類型：C37
發布日期：2008/1/25 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：11.040.99
適用范圍：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. Does not cover other transmissible and non-transmissible agents.