GB/T 18280.3-2025 Pending National standards

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

Publish Date: 2025-12-02 Implement Date: 2027-07-01 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/T 18280.3-2025

Standard Type: National standards

Standard Status: Pending

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2025-12-02

Implement Date: 2027-07-01

Pages: 44 pages

Scope

This document provides guidelines related to dose measurement in GB 18280.1 and GB/T 18280.2, as well as ISO 13004, and their application in the development, validation, and routine control of radiation sterilization processes.
This document is applicable to dose measurement guidelines for the development, validation, and routine control of radiation sterilization of medical devices.
Note: This document is specifically designed for medical devices, but the dose measurement guidelines for the development, validation, and routine control of radiation sterilization can also be applied to other products.

Development Information

Word Count: 67 Thousand words Pages: 44 pages

Same series 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 GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose

Replace the following standards

GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects

Referenced 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 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 GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose

Adopt standards

ISO 11137-3:2017

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