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

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click GB 18280.1-2025 (Self-service in 1-minute)
Newer / historical versions: GB 18280.1-2025

Preview True-PDF

Scope

1.1 This document specifies the requirements for the development, validation and routine
control of a radiation sterilization process for medical devices.
This document applies to irradiation facilities using the following radiation sources.
a) Using radionuclides cobalt-60 or cesium-137;
b) Electron beams emitted from electron accelerators;
c) X-rays emitted from X-ray generators.
1.2 This document does not apply to the sterilization process of inactivated viruses or infectious
spongiform encephalopathy pathogens such as scrapie, bovine spongiform encephalopathy, and
Creutzfeldt-Jakob disease.
NOTE. Relevant information can be found in 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 medical devices to be designated
“STERILE”.
NOTE. For China’s requirements for designating medical devices as “STERILE”, refer to 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 shall refer to the applicable clauses in this
document (see Clause 4). The application of the reference quality management system
standard (see GB/T 42061) in the entire medical device manufacturing process, including
sterilization, is permitted.
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 products listed in the
pharmacopoeia for test for sterility and release.
1.2.4 This document does not specify occupational safety requirements related to the design
and operation of irradiation plants.
NOTE. For Chinese occupational safety regulations related to radiation, refer to GB 10252, GB
18871, and HJ 979.
1.2.5 This document does not specify sterilization requirements for used and reprocessed
medical devices.

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