YY 1277-2023: Steam sterilizer - Performance requirements for biosafety

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Scope

This document specifies the biosafety performance requirements for pressure steam
sterilizers (hereinafter referred to as sterilizers) and describes the corresponding test
methods.
This document applies to the sterilization of materials, instruments, utensils, culture
media, waste and other items for the purpose of biosafety, so as to prevent the
contamination of personnel, animals, plants or the environment by pathogenic factors
transmitted by aerosols and other means.
The sterilizers specified in this document are generally used in laboratories or other
places with biosafety requirements and biosafety level II or above.
This document does not specify safety requirements related to the risk range of use, nor
does it specify requirements for validation and routine control of moist heat sterilization.
This document is not applicable to the sterilization of confined liquids.

Basic Data

Standard ID	YY 1277-2023 (YY1277-2023)
Description (Translated English)	Steam sterilizer - Performance requirements for biosafety
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.10
Word Count Estimation	14,129
Date of Issue	2023-09-05
Date of Implementation	2026-09-15
Older Standard (superseded by this standard)	YY 1277-2016
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the biosafety performance requirements for pressure steam sterilizers (hereinafter referred to as sterilizers) and describes the corresponding test methods. This standard applies to the sterilization of materials, instruments, utensils, culture media, waste and other items for biosafety purposes to prevent pathogenic factors transmitted through aerosol and other methods from contaminating people, animals, plants or the environment. The sterilizers specified in this document are usually used in laboratories or other places with biosafety requirements and biosafety protection levels reaching Level 2 and above. This document does not specify safety requirements involving the risk range of use, nor does it specify requirements for confirmation and routine control of moist heat sterilization. This document does not apply to the sterilization of closed liquids.