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YY 0503-2023: Ethylene oxide sterilizer
Status: Valid YY 0503: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0503-2023 | English | 519 |
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Ethylene oxide sterilizer
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YY 0503-2023
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| YY 0503-2016 | English | 639 |
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Ethylene oxide sterilizer
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YY 0503-2016
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| YY 0503-2005 | English | 639 |
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PDF similar to YY 0503-2023
Standard similar to YY 0503-2023 YY/T 0802.1 YY/T 1268 YY 0451 YY 0504 Basic data | Standard ID | YY 0503-2023 (YY0503-2023) | | Description (Translated English) | Ethylene oxide sterilizer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.10 | | Word Count Estimation | 25,237 | | Date of Issue | 2023-06-20 | | Date of Implementation | 2025-07-01 | | Older Standard (superseded by this standard) | YY 0503-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the classification and requirements of ethylene oxide sterilizers (hereinafter referred to as sterilizers), and describes the corresponding test methods. This standard applies to automatic control sterilizers that use ethylene oxide gas (whether it is pure ethylene oxide gas or a mixture with other gases) as a sterilizing agent. The sterilizer can be used for industrial production sterilization of medical devices and sterilization in medical institutions. This standard does not apply to sterilization methods and equipment that directly inject ethylene oxide or a mixture containing ethylene oxide into the packaging or flexible cavity. This standard does not specify the requirements for the pressure vessel of the sterilizer, nor does it specify the waste gas, waste water and other waste treatment requirements and the residual amount of ethylene oxide produced in the ethylene oxide sterilization. | YY 0503-2023: Ethylene oxide sterilizer---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.080.10
CCSC47
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0503-2016
Ethylene oxide sterilizer
Published on 2023-06-20
2025-07-01 Implementation
Released by the State Drug Administration
Table of contents
Preface III
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Category 2
5 Requirement 2
6 Test methods 11
Appendix A (Informative) Limits for Vapor Pollutants15
Appendix B (Normative) Test Instruments 16
Appendix C (normative) Sterilization room temperature and humidity distribution test 17
Appendix D (Normative) Tightness test of sterilization chamber 18
Appendix E (normative) Type test of microbial killing performance of Class B ethylene oxide sterilizer 19
Reference 20
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY 0503-2016 "Ethylene Oxide Sterilizer". Compared with YY 0503-2016, except for structural adjustments and editorial changes,
In addition, the main technical changes are as follows.
---Changed the description of the standard scope (see Chapter 1, Chapter 1 of the.2016 edition);
---Deleted the terms "sterilizer", "sterilizing agent", "sterilization temperature", "sterilization pressure" and "sterilization humidity" (see 3.1, 3.4,.2016 version)
3.5, 3.6, 3.7), adding the terms "ethylene oxide aerosol can" and "ethylene oxide gas cylinder" (see 3.9, 3.10);
---Mark removed (see 4.2 of the.2016 version);
---Deleted normal working conditions (see 5.1 of the.2016 version);
---Changed the appearance requirements (see 5.1, 5.2 of the.2016 version);
---Changed the size requirements (see 5.2, 5.3 of the.2016 version);
---Changed the requirements for materials and structures (see 5.3.1, 5.4.1 of the.2016 edition);
---Changed the requirements for connecting pipes for testing (see 5.3.2, 5.4.2 of the.2016 version);
---Changed the requirements for components (see 5.4, 5.5.1 of the.2016 edition);
---Changed the requirements for pipes and fittings (see 5.5, 5.5.2 of the.2016 edition);
---Deleted the requirements for gaskets and seals (see 5.5.3 of the.2016 edition);
---Deleted the reliability requirements (see 5.5.4 of the.2016 version);
---Changed the general requirements for doors and their interlocking devices (see 5.6.1,.2016 version of 5.6.1);
---Changed the control requirements for double-door sterilizer doors (see 5.6.4,.2016 version of 5.6.4);
---Deleted the control valve requirements (see 5.7 of the.2016 edition);
---Deleted the water requirement (see 5.8.1 of the.2016 version);
---Changed the requirements for steam (see 5.7.1, 5.8.2 of the.2016 version);
---Changed the requirements for air and/or inert gas filters (see 5.7.3, 5.8.4 of the.2016 edition);
---Changed the requirements for the supply of ethylene oxide aerosol cans (see 5.7.4.2, 5.8.5.2 of the.2016 version);
---Changed the requirements for the supply of ethylene oxide cylinders (see 5.7.4.3, 5.8.5.4 of the.2016 version);
---Changed the requirements for ethylene oxide gasification (see 5.7.4.4, 5.8.5.3 of the.2016 version);
---Changed the mixing requirements for ethylene oxide gas (see 5.8, 5.8.5.5 of the.2016 version);
---Changed the noise requirements (see 5.9,.2016 version of 5.9);
---Changed the general requirements for instruments and controllers (see 5.11.1,.2016 version of 5.11.1);
---Changed the requirements for indicating instruments (see 5.11.2,.2016 version of 5.11.2);
---Changed the requirements for recording instruments (see 5.11.3,.2016 version of 5.11.3);
---Deleted indicators and recorders with control functions (see 5.11.4 of the.2016 version);
---Changed the requirements for sterilization cycle and automatic control (see 5.11.4, 5.11.7 of the.2016 version);
---Changed the requirements for override control of automatic control (see 5.11.5,.2016 version of 5.11.8);
---Deleted the control device (see 5.11.9 of the.2016 version);
---Changed the requirements for sterilization cycle (see 5.12,.2016 version of 5.12);
---Changed the requirements for the leakage test cycle (see 5.13,.2016 version of 5.13);
---Deleted the information provided by the manufacturer (see 5.16 of the.2016 version);
---Deleted environmental testing (see 5.18 of the.2016 version);
---Deleted the test conditions (see 6.1 of the.2016 version);
---Changed the requirements for material and structural testing (see 6.3, 6.4 of the.2016 edition);
---Changed the requirements for testing of pipes and fittings (see 6.5, 6.6 of the.2016 edition);
---Deleted the control valve test (see 6.7 of the.2016 edition);
---Changed the requirements for supply service testing (see 6.7, 6.8 of the.2016 edition);
--- Added circulation system test (see 6.8);
---Changed the requirements for instrumentation and controller testing (see 6.11,.2016 version of 6.11);
---Changed the requirements for performance requirements testing (see 6.14,.2016 version of 6.14);
---Deleted the information test provided by the manufacturer (see 6.16 of the.2016 version);
---Deleted environmental testing (see 6.18 of the.2016 version);
---Deleted inspection rules (see Chapter 7 of the.2016 edition);
---Deleted the logo and instructions for use (see Chapter 8 of the.2016 edition);
---Deleted packaging, transportation and storage (see Chapter 9 of the.2016 edition);
---Changed the requirements for test instruments in Appendix B (see Appendix B, Appendix B of the.2016 version);
---Changed the requirements for the temperature and humidity distribution test of the sterilization room in Appendix C (see Appendix C, Appendix C of the.2016 version);
---Changed the requirements for the sealing test of the sterilization chamber in Appendix D (see Appendix D, Appendix D of the.2016 version).
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed and coordinated by the National Technical Committee for Standardization of Disinfection Technology and Equipment (SAC/TC200).
The previous versions of this document and the documents it replaces are as follows.
---First released as YY 0503-2005 in.2005, first revised in.2016;
---This is the second revision.
Ethylene oxide sterilizer
1 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 products that use ethylene oxide gas (whether pure ethylene oxide gas or a mixture with other gases) as a sterilizing agent.
Automatically controlled sterilizer. Sterilizers can be used for industrial production sterilization of medical devices and sterilization in medical institutions.
This document does not apply to sterilization methods that directly inject ethylene oxide or mixtures containing ethylene oxide into packaging or flexible cavities.
equipment.
This document does not stipulate the pressure vessel requirements for sterilizers, nor does it stipulate the treatment requirements for waste gas, waste water and other waste generated during ethylene oxide sterilization.
Sum the ethylene oxide residues.
Note. If the sterilizer box meets the definition of a pressure vessel in special equipment, the sterilizer needs to meet the requirements of the corresponding regulations on pressure vessels.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB 4793.1 Safety requirements for electrical equipment for measurement, control and testing laboratories Part 1.General requirements
GB 4793.4 Safety requirements for electrical equipment for measurement, control and laboratory use Part 4.Sterilizers for processing medical materials
and special requirements for washer-disinfectors
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 18281.1 Biological indicators for sterilization of health care products Part 1.General principles
GB 18281.2 Biological indicators for sterilization of health care products Part 2.Biological indicators for ethylene oxide sterilization
GB/T 19633.1 Packaging of terminally sterilized medical devices Part 1.Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.2 Packaging of terminally sterilized medical devices Part 2.Requirements for validation of forming, sealing and assembly processes
GB/T.19971 Terminology for sterilization of medical and healthcare products
YY/T 0698.4 Packaging materials for terminally sterilized medical devices Part 4.Paper bag requirements and test methods
YY/T 0698.5 Packaging materials for terminally sterilized medical devices Part 5.Sealable combination bags composed of breathable materials and plastic films
and membrane requirements and test methods
3 Terms and definitions
The terms and definitions defined in GB/T.19971, GB/T 18281.1 and the following apply to this document.
3.1
box sterilizercase
The equipment part of the sterilizer used to load sterilized items, including the sterilization chamber.
3.2
sterilizerchamber
An enclosed space for loading sterilized items.
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