GB/T 16886.7-2015: Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

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Scope

This Part of GB/T 16886 specifies allowable limits for residual ethylene oxide
(EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical
devices, procedures for the measurement of EO and ECH, and methods for
determining compliance so that devices may be released.

Basic Data

Standard ID	GB/T 16886.7-2015 (GB/T16886.7-2015)
Description (Translated English)	Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	80,892
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Older Standard (superseded by this standard)	GB/T 16886.7-2001
Regulation (derived from)	National Standard Announcement 2015 No.38
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China