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GB/T 47143-2026: Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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Basic data | Standard ID | GB/T 47143-2026 (GB/T47143-2026) | | Description (Translated English) | Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 66,686 | | Date of Issue | 2026-01-28 | | Date of Implementation | 2027-08-01 | | Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China | GB/T 47143-2026: Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
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ICS 11.080.01
CCSC47
National Standards of the People's Republic of China
Medical product sterilization low-temperature vaporization hydrogen peroxide
Development, validation and sterilization process for medical devices
Conventional control requirements
(ISO 22441.2022, IDT)
Published on 2026-01-28
Implemented on August 1, 2027
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 2
4.Elements of a Quality Management System 9
5.Characteristic description of sterilization factors 9
6.Process and Equipment Characteristic Description 11
7 Product Definition 12
8.Process Definition 13
9 confirmed 14
10 Routine monitoring and control 17
11.Product sterilization and release 17.
12 Maintain process effectiveness 17
Appendix A (Normative) Factors to Consider When Selecting Microorganisms that Can Demonstrate Sterilization Effectiveness 19
Appendix B (Normative) Method 1---Definition of Microbial Population Inactivation Process Based on Natural Conditions (Bioburden Method) 21
Appendix C (Normative) Method 2 – Process Definition Based on Reference Microbial Inactivation and Understanding of Bioburden
(Bioindicators/Bioburden Method) 22
Appendix D (Normative) Method 3---Conserved Process Definition Based on Reference Microbial Inactivation (Overkill Method) 23
Appendix E (Informative) Application Guidelines for this Document 25
Appendix F (Informative) Example 41.Schematic diagram of VH2O2 sterilization cycle
Appendix G (Informative) Environmental Factors 42
Appendix H (Informative) Justification for the Number of Temperature Sensors and Bioindicators 46
Appendix I (Informative) VH2O2 Factors 48
Appendix J (Informative) Recommended Validation Tests 51
Appendix K (Informative) Recommended Test Procedures 55
Reference 59
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 is equivalent to ISO 22441.2022 "Sterilization of medical products - Low-temperature vaporization of hydrogen peroxide - Opening of sterilization processes for medical devices".
"Issuance, confirmation, and routine control requirements".
The following minimal editorial changes have been made to this document.
---The description of the ISO and IEC database URLs in the terms and definitions has been removed;
Note 2 was added in version 3.23.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Disinfection Technology and Equipment (SAC/TC200).
This document was drafted by. Shandong Xinhua Medical Instrument Co., Ltd., Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, and Fudiwei Medical.
Medical Devices (Shanghai) Co., Ltd., Stereo (Shanghai) Trading Co., Ltd., Beliman Medical Equipment (Shanghai) Co., Ltd., and Laoken Medical Technology Co., Ltd.
Limited Liability Company, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Zhejiang Tailin Medical Engineering Co., Ltd.
The main drafters of this document are. Zhang Haijun, Liang Zexin, Gong Hua, Zhang Qing, Cai Jiaman, Xu Weixiong, Wang Zhen, Weng Yijing, Wang Yimin, and Mo Yifei.
Huang Yanqian, Zhao Zhenbo, and Li Zuoyun.
Introduction
This document specifies the development, validation, and routine control of sterilization processes using vaporized hydrogen peroxide (H2O2) aqueous solution as the sterilizing agent.
Control requirements. Vaporized hydrogen peroxide (VH2O2) sterilizers typically operate below 60°C and are mainly used for medical products that are not heat-resistant or moisture-sensitive.
Sterilization of moisture-sensitive medical devices can also be used for the sterilization of other reusable medical devices that have been proven to be compatible with the VH2O2 sterilization process.
The sterilizer operates automatically using preset cycles. Medical device manufacturers can also use VH2O2 sterilizers for sterilization in commercial production processes.
Sterile medical devices are medical devices free of surviving microorganisms. International standards specifying the validation and routine control requirements for the sterilization process must...
When sterile medical devices are required, efforts should be made to minimize incidental microbial contamination before sterilization. Even so, while meeting quality standards...
Medical devices manufactured under standard manufacturing conditions as required by quality management systems (such as ISO 13485) may contain microorganisms before sterilization.
Medical devices are not sterile. The purpose of sterilization is to inactivate microbial contaminants, thereby transforming non-sterile medical devices into sterile medical devices.
The kinetics of microbial inactivation by physical or chemical agents used for sterilization of medical devices can usually be expressed as the number of surviving microorganisms versus the amount of sterilizing agent released.
The exponential relationship between the degree of exposure is used to describe this; this necessarily means that, regardless of the treatment method applied, microorganisms will always have a certain probability of survival.
For a given treatment process, the survival probability depends on the number and resistance of the microorganisms, as well as the environment in which the microorganisms exist during the treatment.
Therefore, within the microbial population affected by sterilization treatment, the sterility of any medical device cannot be guaranteed, and the sterility of the treated population cannot be ensured.
Bacteria are defined based on the probability of the presence of live microorganisms on medical devices.
Exposure to a properly validated, precisely controlled sterilization process is not the only relevant factor providing reliable assurance regarding the processed medical products.
The medical devices are sterile and suitable in this respect for their intended use. Several factors should be considered, including.
a) Microbial status of incoming materials or components;
b) Validation and routine control of any cleaning and disinfection procedures for medical devices;
c) Environmental control for the manufacturing, assembly, and packaging of medical devices;
d) Control of sterilizers and processes;
e) Control of personnel and their hygiene;
f) Aseptic barrier systems, including any applicable protective packaging;
g) Conditions for the transportation and storage of medical devices;
h) Medical device materials and designs in progress.
The types of contaminants on medical devices requiring sterilization vary, which can affect the efficiency of the sterilization process. Medical institutions use various types of medical devices...
Instruments, and medical devices sterilized according to the manufacturer's instructions (see ISO 17664-1), should be considered special cases. Despite the use of cleaning...
Although the process is streamlined, such medical devices may still contain various contaminating microorganisms and residual inorganic or organic pollutants. Therefore, cleaning during the manufacturing process is crucial.
Confirmation and control of the disinfection process are crucial.
Similar to other standardized low-temperature sterilization processes, such as ethylene oxide (ISO 11135) or low-temperature formaldehyde vapor (ISO 25424), physical and chemical sterilization methods are employed.
The parameters specified the VH2O2 sterilization process and were validated using physical, chemical, and microbiological methods.
Note 1.IEC 61010-1 and IEC 61010-2-040 describe operational safety specifications, which are not included in this document. IEC 60204-1 also...
Applicable.
Note 2.This document does not specify occupational safety requirements (see 1.2.4).
This document has two different application scenarios.
---For use by VH2O2 sterilizer manufacturers and users of VH2O2 sterilization processes in medical institutions;
---For manufacturers of VH2O2 sterilizers and users of VH2O2 sterilization processes in the production of medical products.
Medical product sterilization low-temperature vaporization hydrogen peroxide
Development, validation and sterilization process for medical devices
Conventional control requirements
1 Scope
1.1 Applicable
1.1.1 This document specifies the development and verification of a low-temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.
Recognition, routine monitoring and control requirements.
1.1.2 This document is applicable to process developers, sterilization equipment manufacturers, sterile medical device manufacturers, and those performing VH2O2 sterilization processes.
The identified organizations and the organizations responsible for sterilizing medical devices.
Note. VH2O2 sterilizers can be used in medical and industrial settings, and this document acknowledges the similarities and differences between these two applications.
1.2 Not applicable
1.2.1 This document does not cover processes that use other sterilizing agents or hydrogen peroxide solution in combination with other chemicals as sterilizing agents.
Note. For guidance on the validation of such processes, see ISO 14937.
1.2.2 This document does not specify the requirements for the development, validation, and routine control of inactivation processes for pathogens causing spongiform encephalopathy, such as sheep scrapie and bovine spongiform encephalopathy.
Encephalitis and Creutzfeldt-Jakob disease. Specific recommendations have been made in certain countries regarding the handling of materials that may be contaminated by these preparations.
Note. Some VH2O2 sterilization processes indicate that VH2O2 sterilization is effective against spongiform encephalopathy pathogens (such as scrapie in sheep, bovine spongiform encephalitis, and Creutzfeldt-Jakob disease).
It has a certain degree of inactivation effect. However, this inactivation is a specific process, cycle, and test protocol; therefore, the inactivation mentioned here is not part of this document.
Within the scope, and no specific test methods are provided (for more information see references [13], [25] and [29]).
1.2.3 This document does not specify the requirement for medical devices to be labeled as sterile.
Note. See EN556-1 or ANSI/AAMIST67.
1.2.4 This document does not specify occupational safety requirements related to the design and operation of VH2O2 sterilization equipment.
Note. For more information on safety, see the examples in the references. Also refer to national or regional regulations.
1.2.5 This document does not apply to the contents of packaged products, meaning that at any stage of the sterilization process, the environment inside the sterilization chamber will not come into contact with the product.
Products that come into direct contact, such as solutions in sealed bottles.
1.2.6 This document does not include hydrogen peroxide sterilization systems used in rooms, chambers, or ambient spaces.
Note. These sterilization systems operate under environmental conditions (such as temperature and pressure) and generally employ methods different from the VH2O2 sterilization process described in this document.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
ISO 10993-1 Biological evaluation of medical devices – Part 1.Evaluation and testing in a risk management process
Note. GB/T 16886.1-2022 Biological evaluation of medical devices – Part 1.Evaluation and testing in risk management processes (ISO 10993-1.
2018, IDT)
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