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YY 0503-2023 English PDF

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Q: Should I purchase the latest version YY 0503-2023?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0503-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$519.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0503-2023: Ethylene oxide sterilizer
Status: Valid

YY 0503: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0503-2023	519	Add to Cart	5 days	Ethylene oxide sterilizer	Valid
YY 0503-2016	639	Add to Cart	5 days	Ethylene oxide sterilizer	Valid
YY 0503-2005	639	Add to Cart	3 days	Ethylene oxide sterilizer	Obsolete

Similar standards

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Older Standard (superseded by this standard): YY 0503-2016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

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0503-2023_English be delivered?

Answer: Upon your order, we will start to translate YY 0503-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0503-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0503-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY 0503-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0503-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.