Standard No.:	GB/T 16886.6-1997
English Name:	Biological evaluation of medical devices--Part 6:Tests for local effects after implantation
Chinese Name:	医疗器械生物学评价 第6部分：植入后局部反应试验
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:	State Technical Supervision Bureau
Issued on:	1997-06-26
Implemented on:	1997-12-1
Status:	superseded
Superseded by:	GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
Superseded on:	2017-4-1
Abolished on:	2017-04-01
Target Language:	English
File Format:	PDF
Word Count:	6500 words
Translation Price(USD):	195.0
Delivery:	via email in 1~3 business day

本标准规定了在肉眼和显微镜观察水平上评价材料植入活体组织内局部反应的试验方法。本标准适用于植入到活体某一部位组织内试验材料的生物学安全性评价。植入物不承受机械或功能负荷。局部反应的评价系根据试验样品引起的组织反应，与已经临床确认可接受的医疗器械所用材料引起的组织反应进行比较并作出判定。