Standard No.:	GB/T 16886.9-2001
English Name:	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Chinese Name:	第9部分：潜在降解产物的定性和定量框架
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by:	AQSIQ
Issued on:	2001-9-24
Implemented on:	2002-2-1
Status:	superseded
Superseded by:	GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products
Superseded on:	2018-7-1
Target Language:	English
File Format:	PDF
Word Count:	4500 words
Translation Price(USD):	130.0
Delivery:	via email in 1~3 business day

GB/T 16886的本部分为系统评价医疗器械潜在的和已观察到的生物降解提供了一般原则，为生物降解研究的设计与进行提供了一般原则。GB/T 16886的本部分不适用于下列情况：a) 工程化的活体组织产品；b) 评价或研究由机械过程生成降解产物的方法学。生成这类降解产物的方法可视情况在具体产品标准中规定；c) 非降解产物的可沥滤组分。当产品标准中提供了适用于某种产品的降解产物定性与定量的方法时，这些标准优先于GB/T 16886的本部分。