YY 0503-2023 Active Industry standards-Medicine

YY 0503-2023 Ethylene oxide sterilizer

YY 0503-2023 Ethylene oxide sterilizer

Publish Date: 2023-06-20 Implement Date: 2025-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY 0503-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Disinfection equipment

Publish Date: 2023-06-20

Implement Date: 2025-07-01

Pages: 28 pages

Scope

This document specifies the classification and requirements of ethylene oxide sterilizers (hereinafter referred to as sterilizers), and describes the corresponding test methods. This document applies to automatically controlled sterilizers that use ethylene oxide gas (whether pure ethylene oxide gas or a mixture with other gases) as a sterilizing agent. Sterilizers can be used for sterilization in medical device production and in medical institutions. This document does not apply to the sterilization methods and equipment that directly inject ethylene oxide or mixtures containing ethylene oxide into packaging or flexible chambers. This document does not specify the pressure vessel requirements for sterilizers, nor does it specify the requirements for the treatment of waste gas, wastewater, and other waste generated during ethylene oxide sterilization, or the residual amount of ethylene oxide. Note: If the housing of the sterilizer meets the definition of a pressure vessel in special equipment, the sterilizer must meet the requirements of the corresponding regulations for pressure vessels.

Development Information

Word Count: 48 Thousand words Pages: 28 pages

Replace the following standards

YY 0503-2016 Ethylene oxide sterilizer

Referenced Standards

GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.4-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory process GB 4793.4-2019 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4:Particular requirements for sterilizers and washer-disinfectors used to treat medical materials GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization GB 18281.2-2015 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19971-2005 Sterilization of health care products—Vocabulary GB/T 19971-2015 Sterilization of health care products—Vocabulary YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods YY/T 0698.5-2009 Packaging materials for terminal sterilized medical devices—Part 5:Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods GB/T 18281.2-2024 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization processes GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 19971-2026 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards

Related Standards

GB 15979-2002 Replaced

GB 15979-2002 Hygienic standard for disposable sanitary products

Publish Date: 2002-03-05

YY 0504-2005 Replaced

YY 0504-2005 Portable mode steam sterilizers

Publish Date: 2005-04-05

YY 1007-2005 Replaced

YY 1007-2005 Vertical mode steam sterilizers

Publish Date: 2005-12-07

GB 4793.8-2008 Replaced

GB 4793.8-2008 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-042:Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes

Publish Date: 2008-03-24

YY 0646-2008 Replaced

YY 0646-2008 Small steam sterilizers—Automatic type

Publish Date: 2008-04-25

YY 0215-2008 Replaced

YY 0215-2008 Medical ozone disinfecting cabinets

Publish Date: 2008-10-17