GB 18281.4-2015: Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes

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Scope

This part of GB 18281 specifies the special requirements and test methods for test
organisms, suspensions, inoculated carriers, and biological indicators to be used in the
evaluation of sterilizer performance and sterilization process. The sterilizer shall use
dry heat air for sterilization, and the sterilization temperature range shall be
120 ℃~180 ℃.
Note 1: Refer to GB/T 19974 for the confirmation and routine control of dry heat sterilization.
Note 2: Refer to the relevant regulations of the country for the safety of the workplace.

Basic Data

Standard ID	GB 18281.4-2015 (GB18281.4-2015)
Description (Translated English)	Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	11,115
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Quoted Standard	ISO 11138-1-2006; ISO 18472
Adopted Standard	ISO 11138-4-2006, 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 the specific requirements and test methods to be used in the evaluation of performance and sterilization processes of sterilizers used in the testing of emblem organisms, bacterial suspensions, bacteria carriers, biological indicators, the sterilizer using dry hot air for off Bacteria, sterilization temperature range of 120 �� ~ 180 ��.