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Basic data
| Standard ID | GB 18280.1-2025 (GB18280.1-2025) |
| Description (Translated English) | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| Sector / Industry | National Standard |
| Classification of Chinese Standard | C47 |
| Classification of International Standard | 11.080.01 |
| Word Count Estimation | 37,344 |
| Date of Issue | 2025-12-02 |
| Date of Implementation | 2029-01-01 |
| Older Standard (superseded by this standard) | GB 18280.1-2015 |
| Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China |
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
---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 11.080.01
CCSC47
National Standards of the People's Republic of China
Replaces GB 18280.1-2015
Sterilization radiation of medical products
Part 1.Development of sterilization processes for medical devices
Validation and routine control requirements
(ISO 11137-1.2025, MOD)
Released on December 2, 2025; to be implemented on January 1, 2029.
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
Introduction V
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.General Requirements 7.
5.Characteristic description of sterilization factors 7.
6.Characteristic description of processes and equipment 8.
7 Product Definition 9
8.Process Definition 9.
9 Confirm 10
10 Routine monitoring and control 12
11 Product sterilization release 13
12 Maintaining process effectiveness 13
Appendix A (Informative) Guidelines for this document 16
References 28
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 Part 1 of GB (GB/T) 18280, "Sterilization Radiation of Medical Products". GB (GB/T) 18280 has been published as follows.
Part 2.
---Part 1.Requirements for the development, validation and routine control of sterilization processes for medical devices (GB 18280.1);
---Part 2.Establishing Sterilization Dosage (GB/T 18280.2);
---Part 3.Guidelines for the development, validation and routine control of dosimetry (GB/T 18280.3).
This document replaces GB 18280.1-2015 "Sterilization Radiation for Medical and Healthcare Products - Part 1.Development of Sterilization Processes for Medical Devices".
The main technical changes in "Confirmation and Routine Control Requirements" compared to GB 18280.1-2015, aside from structural adjustments and editorial modifications, are as follows.
---Definitions for terms such as processing loading, simulated products, and aseptic barrier systems have been added (see Chapter 3);
---Terms such as change control, D-value, medical device, original manufacturer, sterility test, and additional dosage have been removed (see the.2015 edition of [reference needed]).
Chapter 3);
---Changes were made to dosage, calibration, dosimeter, malfunction, installation qualification, maximum acceptable dose, operational qualification, performance qualification, and process variables.
Definitions of terms such as processing category, product, product family, sterility inspection, and measurement uncertainty (see Chapter 3,.2015 edition).
chapter);
---The management system requirements element has been changed to general requirements (see Chapter 4, Chapter 4 of the.2015 edition);
---The energy level requirements for electron beam and X-ray assessments of induced radioactivity have been changed (see 5.1.2,.2015 version of 5.1.2);
---The requirements for monitoring and controlling process variables have been changed (see 6.1,.2015 version 6.1);
---Design specifications for gamma, electron beam, and X-ray irradiation facilities have been revised (see 6.2,.2015 edition of 6.2);
---The requirements related to the product definition have been changed (see Chapter 7, Chapter 7 of the.2015 edition);
---Changed the transition requirements for establishing the maximum acceptable dose, sterilization dose, and validating the sterilization dose (see Chapter 8,.2015 edition).
Chapter 8);
---Changes have been made to the review and approval requirements for installation qualification, operational qualification, performance qualification, and validation (see Chapter 9,.2015 edition).
Chapter 9);
---Some requirements for routine process monitoring and control have been changed (see Chapter 10, Chapter 10 of the.2015 edition);
---The frequency requirements for bioburden measurement have been changed (see 12.1.2,.2015 version);
---The frequency requirements for sterilization dosage review have been changed (see 12.1.3,.2015 version of 12.1.3).
This document is modified to adopt ISO 11137-1.2025 "Sterilization of medical products – Radiation – Part 1.Development of sterilization processes for medical devices".
Confirmation and routine control requirements.
The technical differences between this document and ISO 11137-1.2025, and the reasons therefor, are as follows.
---The definition of "medical device" (see 3.19 of ISO 11137-1.2025) has been removed to comply with the provisions of my country's medical device regulations;
---ISO 11737-1 (see Chapters 7, 8, and 12) has been replaced with the normatively referenced GB/T 19973.1 to adapt to my country's national standards.
Technical conditions, increasing operability;
---ISO 11737-2 (see Chapter 8) has been replaced with the normatively referenced GB/T 19973.2 to adapt to my country's technical conditions, and [further details are needed].
Operability;
---The normative references to ISO 13004 and ISO /ASTM 52628 (see 7.3 and 4.3 of ISO 11137-1.2025) have been removed, in order to
In line with my country's national conditions;
---The requirement for dosage measurement procedures to comply with ISO /ASTM 52628 has been changed to the content in Note 4.3 to suit my country's national conditions;
---The requirement for repetitive dose distribution testing in operational and performance qualification has been revised to the content noted (see Chapter 9) to comply with Chinese regulations.
National conditions.
The following editorial changes have been made to this document.
---The scope note has been removed to adapt to the situation in my country's medical industry;
---Notes in sections 1.2.1 and 1.2.4 have been revised to include relevant Chinese occupational safety standards related to radiation;
---Referencing GB/T 18280.2, GB/T 18280.3, GB/T 19000, GB/T 19001, GB/T 19004, etc.
GB/T 19022, GB/T 24001, GB/T 24040, GB/T 42061, GB/T 44353.1, GB/T 44353.2,
YY/T 0771.3 replaced ISO 11137-2, ISO 11137-3, ISO 9000, ISO 9001, and ISO 9004, respectively.
ISO 10012-1, ISO 14001, ISO 14040, ISO 13485, ISO 22442-1, ISO 22442-2, ISO 22442-3;
---The content in section 4.1 has been deleted.
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 and is under the jurisdiction of the National Medical Products Administration.
The release history of this document and the document it replaces is as follows.
---First published as GB 18280-2000 in.2000, and revised for the first time in.2015;
---This is the second revision.
Introduction
GB (GB/T) 18280 "Sterilization Radiation for Medical Products" is a general and specific standard concerning the use of radiation for sterilization of medical devices.
Standard. GB (GB/T) 18280 aims to provide requirements for the development, validation, and routine control of radiation sterilization processes for medical devices, as well as for establishing sterilizing agents.
The methods and guidelines for measuring radiation dose are proposed to consist of three parts.
---Part 1.Development, Validation, and Routine Control Requirements for Medical Device Sterilization Processes. The aim is to provide guidelines for radiation sterilization of medical devices.
Specific requirements for the development, validation, and routine control of microbial processes.
---Part 2.Establishing Sterilization Doses. The purpose is to provide specific requirements for establishing radiation sterilization doses.
---Part 3.Guidelines for the Development, Validation, and Routine Control of Dosimetry. The aim is to provide guidance for the radiation sterilization process of medical devices.
Guidelines for the development, validation, and routine control of relevant dose measurements.
Sterilization radiation of medical products
Part 1.Development of sterilization processes for medical devices
Validation and routine control requirements
1 Scope
1.1 This document specifies the requirements for the development, validation, and routine control of radiation sterilization processes for medical devices.
This document applies to irradiation devices that use the following radiation sources.
a) Use the radioactive nuclides cobalt-60 or cesium-137;
b) Electron beams emitted by electron accelerators;
c) X-rays emitted by an X-ray generator.
1.2 This document does not apply to inactivated viruses or infectious spongiform encephalopathy pathogens such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease.
Sterilization process.
Note. For relevant information, please refer to GB/T 44353.1, GB/T 44353.2, YY/T 0771.3, ISO 13022 and ICHQ5A.
1.2.1 This document does not specify the requirements for medical devices labeled as sterile.
Note. For my country's requirements for designating medical devices as "sterile", see YY/T 0615.1.
1.2.2 This document does not specify a quality management system for controlling all stages of the medical device manufacturing process.
Note. This document does not require the establishment of a complete quality management system in manufacturing, but the elements that need to be controlled in the sterilization process within the quality management system should be referred to in this document.
Applicable terms (see Chapter 4). Refer to the quality management system standard (see GB/T 42061) for the entire medical device manufacturing process, including sterilization.
Applications.
1.2.3 This document does not require the use of biological indicators in the validation and monitoring of radiation sterilization, nor does it require the use of sterility testing methods as specified in the pharmacopoeia.
Products sold online.
1.2.4 This document does not specify occupational safety requirements related to the design and operation of irradiation plants.
Note. Occupational safety regulations related to radiation in my country are found in GB 10252, GB 18871 and HJ979.
1.2.5 This document does not specify sterilization requirements for used and reprocessed medical devices.
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.
GB/T 19973.1 Microbiological methods for sterilization of medical and health care products – Part 1.Determination of total microbial count on the product
(GB/T 19973.1-2023,ISO 11737-1.2018,IDT)
GB/T 19973.2 Microbiological methods for sterilization of medical products – Part 2.Definition, validation and maintenance of sterilization processes
Aseptic test (GB/T 19973.2-2025, ISO 11737-2.2019, IDT)
3 Terms and Definitions
The following terms and definitions apply to this document.
...
