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
利用动物组织及其衍生物的医疗器械第3部分:病毒和传染性海绵状脑病(TSE)制剂的消除和/或灭活验证
发布日期:
2007-11-27
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) utilizinganimal 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.