GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices (English Version)
Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2025 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
1 Scope
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
This document is applicable to irradiators using the following radiation sources:
a) The radionuclide 60Co or 137Cs;
b) A electron beam from an electron accelerator;
c) X-rays from an X-ray generator.
1.2 This document is not applicable to sterilization processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
Note: For information on such processes, see GB/T 44353.1, GB/T 44353.2, YY/T 0771.3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
Note: For requirements designating medical devices as "sterile" in China, see YY/T 0615.1.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
Note: It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are necessary to control the sterilization process are normatively referenced in appropriate provisions in this document (see Clause 4). Refer to the application of the standards for quality management systems (see GB/T 42061) throughout all stages of production of medical devices, including the sterilization process.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
Note: For China's regulations on occupational safety related to radiation, see GB 10252, GB 18871 and HJ 979.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed medical devices.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19973.1 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (GB/T 19973.1-2023, ISO 11737-1:2018, IDT)
GB/T 19973.2 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (GB/T 19973.2-2025, ISO 11737-2:2019, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
dose
absorbed dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
Note: The unit of absorbed dose is the gray (Gy), where 1 Gy=1 J/kg (=100 rad).
[Source: ISO 11139:2018, 3.3, modified]
3.2
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[Source: ISO 11139:2018, 3.23]
3.3
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified sterilization process
[Source: ISO 11139:2018, 3.29]
3.4
calibration
Contents
Foreword II
Introduction V
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance on this document
Bibliography
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices (English Version)
Standard No.
GB 18280.1-2025
Status
to be valid
Language
English
File Format
PDF
Word Count
15500 words
Price(USD)
465.0
Implemented on
2029-1-1
Delivery
via email in 1 business day
Detail of GB 18280.1-2025
Standard No.
GB 18280.1-2025
English Name
Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2025 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
1 Scope
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
This document is applicable to irradiators using the following radiation sources:
a) The radionuclide 60Co or 137Cs;
b) A electron beam from an electron accelerator;
c) X-rays from an X-ray generator.
1.2 This document is not applicable to sterilization processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
Note: For information on such processes, see GB/T 44353.1, GB/T 44353.2, YY/T 0771.3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
Note: For requirements designating medical devices as "sterile" in China, see YY/T 0615.1.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
Note: It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are necessary to control the sterilization process are normatively referenced in appropriate provisions in this document (see Clause 4). Refer to the application of the standards for quality management systems (see GB/T 42061) throughout all stages of production of medical devices, including the sterilization process.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
Note: For China's regulations on occupational safety related to radiation, see GB 10252, GB 18871 and HJ 979.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed medical devices.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19973.1 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (GB/T 19973.1-2023, ISO 11737-1:2018, IDT)
GB/T 19973.2 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (GB/T 19973.2-2025, ISO 11737-2:2019, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
dose
absorbed dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
Note: The unit of absorbed dose is the gray (Gy), where 1 Gy=1 J/kg (=100 rad).
[Source: ISO 11139:2018, 3.3, modified]
3.2
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[Source: ISO 11139:2018, 3.23]
3.3
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified sterilization process
[Source: ISO 11139:2018, 3.29]
3.4
calibration
Contents of GB 18280.1-2025
Contents
Foreword II
Introduction V
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance on this document
Bibliography
