Standard No.:	YY/T 0567.7-2016
English Name:	Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products
Chinese Name:	医疗保健产品的无菌加工第7部分：医疗器械及组合型产品的替代加工
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-07-29
Implemented on:	2017-6-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	10000 words
Translation Price(USD):	320.0
Delivery:	via email in 1~5 business day

本标准规定了对于不能进行最终灭菌，而且不适用于YY/T 0567.1-2013模拟生产方法的医疗器械及组合产品中，无菌加工性能确认的模拟生产替代方法的要求。本标准适用于在开发无菌加工期间，当加工中不允许直接使用培养基替代产品，或者培养基不能替代实际的无菌加工时，使用风险评定来设计医疗器械及组合产品的模拟生产研究。