GB 18281.5-2015: Sterilization of health care products -- Biological indicator -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

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Scope

GB 18281 of the provisions of this part of the test microorganisms, bacterial suspension, the carrier contamination, biological indicator and low temperature steam formaldehyde sterilization
General requirements for sterilization agent to assess the treatment effect of biological indicator test method.
Note 1.The requirements for low temperature steam formaldehyde sterilization process control and confirmation, see ISO 14937.
Note 2.For the safety requirements in the workplace, see national or regional regulations.

Basic Data

Standard ID	GB 18281.5-2015 (GB18281.5-2015)
Description (Translated English)	Sterilization of health care products -- Biological indicator -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	12,165
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Quoted Standard	GB 18281.1-2015
Adopted Standard	ISO 11138-5-2006, 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 test microorganisms, bacterial suspension, the carrier contamination, biological indicator of low temperature steam and formaldehyde as sterilizing agent to assess the effect of the general requirements for sterilization of biological indicator test method.