请选择需要导出的字段：
ISO 22442-3-2007
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 first edition
适用范围：This part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of virusesand 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 renderednon-viable. It applies where required by the risk management process as described in ISO 22442-1. It doesnot cover other transmissible and non-transmissible agents.NOTE 1 Analysis and management of risk is described in ISO 22442-1. Conventional processes used for sterilization,when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective ininactivating the causative agents of transmissible spongiform encephalopathy. Selective sourcing is extremely important(see ISO 22442-1 and ISO 22442-2).NOTE 2 ISO 11135, ISO 11137, ISO 11737-1, ISO 13408, ISO 14160, ISO 14937 and ISO 17665 may be relevant forbacteria, moulds and yeast (see Bibliography).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 part of aquality management system conforming to ISO 13485.This part of ISO 22442 does not consider the effect of any method of elimination and/or inactivation on thesuitability of the medical device for its intended use.
知识产权声明 | 服务承诺 | 联系我们 | 客户服务 | 关于我们
互联网出版许可证：新出网证(京)字042号 互联网药品信息服务资格证书号：(京)-经营性-2011-0017 信息网络传播视听节目许可证 许可证号：0108284
万方数据标准管理系统V1.0 证书号:软著登字第4252816号
京ICP证：010071 京公网安备11010802020237号 京ICP备08100800号-1
客服电话：4000115888 客服邮箱：service@wanfangdata.com.cn 违法和不良信息举报电话：4000115888 举报邮箱：problem@wanfangdata.com.cn 举报专区：https://www.12377.cn
万方数据知识服务平台--国家科技支撑计划资助项目（编号：2006BAH03B01）©北京万方数据股份有限公司 万方数据电子出版社
