GB 18281.1-2015: Sterilization of health care products -- Biological indicators -- Part 1: General requirements

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Scope

1.1 Application
1.1.1 GB 18281 of the provisions of this part of the biological indicators intended to be used to identify and monitor the sterilization cycles (including carrier contamination, the test bacteria suspension
Liquid) and other components in the production, labeling, testing methods and general performance requirements.
Basic requirements 1.1.2 This section applies to all other parts of GB 18281. For special process for sterilization of biological indicator
Requirements in other parts of GB 18281 has prescribed. This section does not apply to the special requirements of biological indicators.
1.2 NA
This section does not apply to rely on physically removing microbial detection system, such as filtration or the use of cleaning and disinfection or steam circulation
Steam and other physical and/or mechanical methods to remove microbial process. However, this section should contain content appropriate microbiological testing system.

Basic Data

Standard ID	GB 18281.1-2015 (GB18281.1-2015)
Description (Translated English)	Sterilization of health care products -- Biological indicators -- Part 1: General requirements
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	35,358
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Older Standard (superseded by this standard)	GB 18281.1-2000
Quoted Standard	ISO 8601; ISO 11135-1; ISO 11135-2; ISO 11137-1; ISO 11137-2; ISO 11137-3; ISO 11607-1; ISO 11607-2; ISO 11737-1; ISO 13485; ISO 15223; ISO 17665-1; ISO 18472
Adopted Standard	ISO 11138-2006, 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 International Standard specifies general requirements for the production, labeling, testing methods and performance of biological indicators (including stained carriers, suspension of test bacteria) and other components intended for use in the validation and monitoring of sterilization cycles. The basic requirements of this standard apply to the other parts of GB 18281. The requirements for biological indicators used in special sterilization processes are specified in other parts of GB 18281. This standard applies to biological indicators without special requirements. This International Standard does not apply to the physical removal of microbiological testing systems, such as filtration processes or physical and/or mechanical processes such as cleaning sterilizers or circulating steam. However, this standard shall contain the contents of the corresponding emblem biological testing system.