GB/T 18280.3-2025Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (English PDF)
医疗产品灭菌 辐射 第3部分：开发、确认和常规控制的剂量测量指南
Also coversGB/T18280.3-2025 + GBT18280.3-2025
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 2, 2025
Implementation date
July 1, 2027
Scope
GB/T 18280.3-2025 is the English-translated version of 医疗产品灭菌 辐射 第3部分：开发、确认和常规控制的剂量测量指南.
Radiation sterilization of medical products relies on measuring absorbed dose reliably. This document gives guidance on the dosimetric aspects of developing, validating and routinely controlling a radiation sterilization process for medical devices. It supports the requirements set out in the first two parts of the series and in the related international standard, and it is a guidance-oriented recommended national standard.
The scope notes that the guidance is aimed at medical devices, although the dose measurement guidance may also be applied to other products. Sterilization service providers, device manufacturers, dosimetry laboratories and quality and regulatory staff who manage radiation sterilization are the main users.
It was issued on 2 December 2025 and takes effect on 1 July 2027, replacing GB/T 18280.3-2015. The long lead time gives organisations room to review their dosimetry procedures against the new text.
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Document preview — GB/T 18280.3-2025
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C47
- Replacing
- GB/T 18280.3-2015
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
GB/T 18280.3-2025 is a recommended national standard (GB/T) of the People's Republic of China, issued on 2 December 2025 by the State Administration for Market Regulation and the Standardization Administration of China, with effect from 1 July 2027.
This edition replaces GB/T 18280.3-2015.
The document adopts an international standard (ISO or IEC).
It is under the responsibility of the National Medical Products Administration.
Classification: ICS 11.080.01; CCS C47.
1 Scope
Radiation sterilization of medical products relies on measuring absorbed dose reliably. This document gives guidance on the dosimetric aspects of developing, validating and routinely controlling a radiation sterilization process for medical devices. It supports the requirements set out in the first two parts of the series and in the related international standard, and it is a guidance-oriented recommended national standard.
The scope notes that the guidance is aimed at medical devices, although the dose measurement guidance may also be applied to other products. Sterilization service providers, device manufacturers, dosimetry laboratories and quality and regulatory staff who manage radiation sterilization are the main users.
It was issued on 2 December 2025 and takes effect on 1 July 2027, replacing GB/T 18280.3-2015. The long lead time gives organisations room to review their dosimetry procedures against the new text.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.
Referenced standards
Cited by
- GB/T 45351-2025Manufacture of cell-based medical devices - Control of microbial risks during processing
- GB/T 12279.1-2024Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- GB/T 44138-2024Cardiovascular implants - Cardiovascular absorbable implants
- YY 0861-2024Ophthalmic optics - Ophthalmic viscosurgical devices
- YY/T 1743-2021Anaesthetic and respiratory equipment—Nebulizing systems and components
- YY/T 0726-2020Instrumentation for use in association with non-active surgical implants - General requirements
Similar standards
Editions of GB/T 18280.3
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 18280.3-2025 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control | current edition | Current |
| GB/T 18280.3-2015 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects | previous edition | In force until 1 July 2027 |
This page sells the current edition, GB/T 18280.3-2025. Earlier editions are listed for reference only.
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Related Standards
GB/T 18280.2-2025 — Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
GB/T 18280.3-2015 — Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimeter aspects
GB/T 7251.4-2026 — Low-voltage switchgear and controlgear assemblies - Part 4: Particular requirements for assemblies for construction sites (ACS)
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