GB 18280-2000Sterilization of health care products. Requirement for validation and routine control. Radiation sterilization (English PDF)
医疗保健产品灭菌 确认和常规控制要求 辐射灭菌
GB 18280 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| 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 | Valid |
| 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 | Obsolete |
| GB 18280-2000 | Sterilization of health care products. Requirement for validation and routine control. Radiation sterilization | Obsolete |
GB 18280-2000 is obsolete. It has been replaced by GB 18280.1-2015. This page sells the obsolete edition, for projects and contracts that still cite it.
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Issued by
State Quality and Technology Supervision Bureau
Level / Type
National · Mandatory
Issue date
January 2, 2000
Implementation date
May 1, 2001
Scope
GB 18280-2000 is the English-translated version of 医疗保健产品灭菌 确认和常规控制要求 辐射灭菌.
GB 18280-2000 is the Chinese national standard "Sterilization of health care products. Requirement for validation and routine control. Radiation sterilization".
It was issued on January 2, 2000 by the State Quality and Technology Supervision Bureau, and took effect on May 1, 2001. It is obsolete: it has been replaced by GB 18280.1-2015.
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Document preview — GB 18280-2000
National Standard of the People's Republic of China
Issued by: State Quality and Technology Supervision Bureau
Contents
- Document data
1 Document data
Sector: National standard (Mandatory).
Issuing body: State Quality and Technology Supervision Bureau.
Date of issue: 2000-01-02.
Date of implementation: 2001-05-01.
Status: obsolete, replaced by GB 18280.1-2015.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.
Referenced standards
Cited by
- GB/T 12279.1-2024Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- YY/T 1787-2021Cardiovascular implants—Cardiac valve repair devices and delivery system
- YY/T 1618-2018Single-use needles for human venous blood specimen collection
- YY/T 1553-2017Cardiovascular implants-Cardiac occluder
- YY/T 1571-2017Tissue engineering medical device products—Sodium hyaluronate
- YY 0118-2016Joint replacement implants - Hip joint prostheses
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Related Standards
GB 18280.1-2025 — Sterilization of health care products - Radiation - Part 1: Requirements for the development
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 18280.2-2015 — Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
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GB 18280-2000
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