YY/T 1463-2016 in English

VALID

Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites

Issued on:2016-01-26
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $100.00
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Standard No:	YY/T 1463-2016
Document status:	VALID
Title in English:	Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites
Title in Chinese:	医疗器械灭菌确认选择微生物挑战和染菌部位的指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-01-26
Implemented on:	2017-01-01
ICS Classification:	11.080.01-Sterilization and disinfection in general
Chinese Classification:	C47-Public medical equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	medical device guidance sterilization validation appropriate contamination sites appropriate microbial challenges microbial challenge
Related Topics:	Bacteria Microbiological Testing of Medical Devices colony selector Contaminated microorganisms Contaminated microorganisms Sterilization in situ Medical Device Challenge Bacteria Sterilization Confirmation Medical Device Confirmation yy/t 1463-2016 Sterilization Confirmation of Sterile Medical Devices Medical Device Confirmation microbiology and medical Microbial sterilizer biological challenge Methods of Sterilization of Microorganisms yy/t+1463 Microbiological Requirements for Medical Devices Methods of Microbial Sterilization Challenging Experiments on Fungicides Microbial sterilization temperature and time Medical device raw material selection Medical device microbial testing Indicator organism selection method Disk method for contacting microorganisms on the surface of medical devices

本标准规定了灭菌确认过程中选择合适的微生物挑战、合适的染菌部位、染菌方法以及复苏染菌微生物的技术。
本标准适用于医疗器械制造商进行灭菌确认试验。
本标准不适用于常规的灭菌试验，不适用于医疗器械清洁效果确认或消毒确认中的微生物挑战或染菌过程。

Scope

This standard provides guidance for selecting appropriate microbial challenges, appropriate contamination sites, contamination methods, and techniques for resuscitating contaminated microorganisms during sterilization validation. This standard is suitable for medical device manufacturers to conduct sterilization confirmation tests, but not for routine sterilization tests. This standard does not apply to microbial challenges or contamination processes in medical device cleaning effectiveness confirmation or disinfection confirmation.

More samples: GB 50021-2001(2009) DL/T 368-2010 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1463-2016

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