GB 18280.1-2025 Pending National standards force_standard

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

Publish Date: 2025-12-02 Implement Date: 2029-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB 18280.1-2025

Standard Type: National standards

Standard Status: Pending

is_force_gb: yes

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2025-12-02

Implement Date: 2029-01-01

Pages: 40 pages

Scope

1.1 This document specifies the requirements for the development, validation, and routine control of the radiation sterilization process for medical devices.
This document is applicable to irradiation devices that use the following radiation sources:
a) Cobalt-60 or Cesium-137 radioisotopes;
b) Electron beams emitted by electron accelerators;
c) X-rays emitted by X-ray generators.

Development Information

Word Count: 63 Thousand words Pages: 40 pages

Same series standard

GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control

Replace the following standards

GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

Referenced Standards

GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.2-2005 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the validation of a sterilization process GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process GB/T 19973.2-2025 Sterilization of health care products—Microbiological methods—Part 2:Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Adopt standards

ISO 11137-1:2025

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05