GB/T 16886.7-2001 in English

SUPERSEDED

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Issued on:2001-09-24
Implemented on:2002-02-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $450.00
$437.00

Standard No:	GB/T 16886.7-2001
Document status:	SUPERSEDED
Superseded by:	GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
Superseded on:	2017-01-01
Title in English:	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Title in Chinese:	医疗器械生物学评价第7部分：环氧乙烷灭菌残留量
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2001-09-24
Implemented on:	2002-02-01
ICS Classification:	11.040.01-Medical equipment in general
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	ethylene oxide medical devices vitro diagnostic devices ethylene sterilization residuals scopethis standard
Related Topics:	biology Ethylene oxide residue Medical Device Biology Medical Device Biology biological evaluation biological evaluation Ethylene oxide residue Ethylene Oxide Residual Chromatography Ethylene oxide residue Biological Evaluation of Medical Devices Biological Evaluation of Medical Devices Ethylene oxide residue evaluation Medical Device Evaluation biological standard Medical Device Evaluation Ethylene oxide evaluation Class I Medical Device Ethylene Oxide GB/T 16886.7-2015 ethylene oxide residual UV GB t16886.7-2001 GB/T 16886.7 GBT16886.7 GB/T 16886.7-2001 GB/T 16886.7-2015 Disabled Peracetic acid residual amount Cultural relics ethylene oxide residue Cyclohexanone residues in medical devices Medical device environmental residue testing Detection of residual ethanol in medical devices Residual amounts of ethylene oxide in pharmaceutical excipients Ethylene oxide sterilization air residue Gas peracetic acid residue Ethylene oxide remains in food and drugs Heavy metal residues in implanted medical devices Residual amount of ethylene oxide in catheter products

《GB/T 16886.7-2001医疗器械生物学评价第7部分:环氧乙烷灭菌残留量》由TC248（全国医疗器械生物学评价标准化技术委员会）归口，主管部门为国家药品监督管理局。
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）。

Scope

This standard specifies the allowable limits of ethylene oxide (EO) and 2-chloroethanol (ECH) residues on medical devices sterilized by ethylene oxide, and the measurement methods for ethylene oxide and 2-chloroethanol and methods for determining whether a device can be released. Additional background information and guidance are given in the appendices to this standard prompt. This standard does not cover those ethylene oxide sterilized devices that do not come into contact with patients (eg, in vitro diagnostic devices).

More samples: YD/T 3934-2021 JC/T 2453-2018 QC/T 942-2021

Sample only — not a preview of GB/T 16886.7-2001

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