Standard No.:	GB/T 16886.7-2001
English Name:	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Chinese Name:	医疗器械生物学评价 第7部分：环氧乙烷灭菌残留量
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
Issued by:	AQSIQ
Issued on:	2001-9-24
Implemented on:	2002-2-1
Status:	superseded
Superseded by:	GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
Superseded on:	2017-1-1
Abolished on:	2017-01-01
Language:	English
File Format:	PDF
Word Count:	15000 words
Price(USD):	450.00
Delivery:	via email in 1~3 business day

本标准规定了经环氧乙烷灭菌的医疗器械单位产品上环氧乙烷（EO）和2-氯乙醇（ECH）残留量的允许极限、环氧乙烷及2-氯乙醇的测量方法以及确定器械是否可以放行的方法。本标准提示的附录中还给出了其他背景资料和指南。本标准不包括那些不与患者接触的经环氧乙烷灭菌的器械（如，体外诊断器械）。