ISO 22442-3:2007 利用动物组织及其衍生物的医疗设备 第3部分：病毒和传染性海绵状脑病（TSE）试剂的消除和/或失效的确认

标准编号：ISO 22442-3:2007

中文名称：利用动物组织及其衍生物的医疗设备 第3部分：病毒和传染性海绵状脑病（TSE）试剂的消除和/或失效的确认

英文名称：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

发布日期：2007-12

标准范围

ISO 22442-3:2007规定了在使用动物组织或从动物组织衍生的产品制造医疗器械（不包括体外诊断医疗器械）期间，对病毒和TSE制剂的消除和/或失活进行验证的要求，这些产品是不可行的或已变得不可行的。它适用于ISO 22442-1中所述的风险管理流程要求的情况。它不包括其他可传播和不可传播的药剂。

ISO 22442-3:2007 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.

标准预览图