GB/T 18282.1-2025Sterilization of health care products - Chemical indicators - Part 1: General requirements (English PDF)
医疗保健产品灭菌 化学指示物 第1部分：通则
Also coversGB/T18282.1-2025 + GBT18282.1-2025
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
January 24, 2025
Implementation date
February 1, 2026
Scope
GB/T 18282.1-2025 is the English-translated version of 医疗保健产品灭菌 化学指示物 第1部分：通则.
Chemical indicators are used in sterilization processes to show whether a load has been exposed to the process conditions. This document is Part 1 of the series on chemical indicators for the sterilization of health care products and covers the general requirements that apply across indicator types.
Its readers include manufacturers of sterilization indicators, producers of sterile medical devices, hospital central sterile services departments, contract sterilizers and test laboratories. Regulatory staff preparing registration dossiers for medical devices and sterilization consumables may also cite it.
The standard was issued on 24 January 2025 and takes effect on 1 February 2026. It replaces GB 18282.1-2015, and the change in prefix shows that the earlier edition carried the GB designation, while this new edition is a recommended national standard (GB/T). That means it is voluntary on its own, unless made binding by a regulation, product registration requirement or contract. Users of the 2015 edition should review how it is cited in their documentation.
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Document preview — GB/T 18282.1-2025
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C47
- Replacing
- GB 18282.1-2015
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 18282.1-2025 is a recommended national standard (GB/T) of the People's Republic of China, issued on 24 January 2025 by the State Administration for Market Regulation and the Standardization Administration of China, with effect from 1 February 2026.
This edition replaces GB 18282.1-2015.
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
Chemical indicators are used in sterilization processes to show whether a load has been exposed to the process conditions. This document is Part 1 of the series on chemical indicators for the sterilization of health care products and covers the general requirements that apply across indicator types.
Its readers include manufacturers of sterilization indicators, producers of sterile medical devices, hospital central sterile services departments, contract sterilizers and test laboratories. Regulatory staff preparing registration dossiers for medical devices and sterilization consumables may also cite it.
The standard was issued on 24 January 2025 and takes effect on 1 February 2026. It replaces GB 18282.1-2015, and the change in prefix shows that the earlier edition carried the GB designation, while this new edition is a recommended national standard (GB/T). That means it is voluntary on its own, unless made binding by a regulation, product registration requirement or contract. Users of the 2015 edition should review how it is cited in their documentation.
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 — 28 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of GB/T 18282.1
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB/T 18282.1-2025 | Sterilization of health care products - Chemical indicators - Part 1: General requirements | current edition | Current |
| GB 18282.1-2015 | Sterilization of health care products - Chemical indicator - Part 1: General requirements | previous edition | In force until 1 February 2026 |
This page sells the current edition, GB/T 18282.1-2025. Earlier editions are listed for reference only.
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