GB 18281.2-2015: Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes

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Scope

GB 18281 of the provisions of this part of the test organisms intended when evaluating the performance of the sterilizer and sterilization processes used, bacterial suspension, carrying contamination
Body, special requirements and test methods for biological indicator, which uses pure ethylene oxide sterilization or it is mixed with other dilution gas sterilization,
Sterilization temperature range is 29 ℃ ~ 65 ℃.
Note 1.ethylene oxide sterilization confirmation and routine control See GB 18279.
Note 2.workplace safety reference to the relevant provisions of the State.

Basic Data

Standard ID	GB 18281.2-2015 (GB18281.2-2015)
Description (Translated English)	Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	12,162
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Older Standard (superseded by this standard)	GB 18281.2-2000
Quoted Standard	GB 18281.1-2015; GB/T 24628-2009
Adopted Standard	ISO 11138-2-2006, IDT
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
Summary	This standard specifies requirements for test organisms and test methods proposed in the evaluation of the performance of sterilizers and sterilization processes used, the bacterial suspension, the carrier contamination, biological indicator, which uses pure ethylene oxide sterilization or it is diluted with other gases mixed sterilized sterilization temperature range is 29 �� ~ 65 ��.