Standard No.:	GB/T 16886.1-2001
English Name:	Biological evaluation of medical devices--Part 1:Evaluation and testing
Chinese Name:	医疗器械生物学评价 第1部分：评价与试验
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:	General Administration of Quality Supervision, Inspection and Quarantine of PRC
Issued on:	2001-09-24
Implemented on:	2002-2-1
Status:	superseded
Superseded by:	GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Superseded on:	2011-12-1
Abolished on:	2011-12-01
Superseding:	GB/T 16886.1-1997 Biological evaluation of medical devices --Part 1:Guidance on selection of tests
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	220.0
Delivery:	via email in 1~3 business day

GB/T 16886的本部分描述了：a) 指导医疗器械生物学评价的基本原则；b) 按器械与人体接触的性质和时间分类；c) 有关试验的选择。GB/T 16886的本部分不涉及与病人身体不直接亦不间接接触的材料和器械，也不涉及由于机械故障所引起的生物学危害。