ANSI/AAMI/ISO 22442-3-2007 医疗设备用动物组织及其衍生物.第3部分:病毒和遗传性海绵状脑病(TSE)试剂的消灭和/或失效的确认

标准号：ANSI/AAMI/ISO 22442-3-2007
中文标准名称：医疗设备用动物组织及其衍生物.第3部分:病毒和遗传性海绵状脑病(TSE)试剂的消灭和/或失效的确认
英文标准名称：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
标准类型：C37
发布日期：2008/1/25 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C37
国际标准分类号：11.040.99
适用范围：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.