GB 18279-2000Medical devices. Validation and routine control of ethylene oxide sterilization (English PDF)
医疗器械 环氧乙烷灭菌 确认和常规控制
GB 18279 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB 18279-2023 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | Valid |
| GB 18279-2000 | Medical devices. Validation and routine control of ethylene oxide sterilization | Obsolete |
GB 18279-2000 is obsolete. It has been replaced by GB 18279-2023. This page sells the obsolete edition, for projects and contracts that still cite it.
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Issued by
State Bureau of Quality and Technical Supervision
Level / Type
National · Mandatory
Issue date
December 18, 2000
Implementation date
May 1, 2001
Scope
GB 18279-2000 is the English-translated version of 医疗器械 环氧乙烷灭菌 确认和常规控制.
GB 18279-2000 is the Chinese national standard "Medical devices. Validation and routine control of ethylene oxide sterilization". It was issued on December 18, 2000 by the State Bureau of Quality and Technical Supervision, and took effect on May 1, 2001. It is obsolete: it has been replaced by GB 18279-2023.
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Document preview — GB 18279-2000
National Standard of the People's Republic of China
Issued by: State Bureau of Quality and Technical Supervision
Contents
- Document data
1 Document data
Sector: National standard (Mandatory).
Issuing body: State Bureau of Quality and Technical Supervision.
Date of issue: 2000-12-18.
Date of implementation: 2001-05-01.
Status: obsolete, replaced by GB 18279-2023.
......
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 45351-2025Manufacture of cell-based medical devices - Control of microbial risks during processing
- GB/T 44875-2024Fallopian rings - Requirements and test methods
- GB/Z 44877-2024Sterilization of medical devices - Guidance on using parametric release for ethylene oxide sterilization process
- YY 0861-2024Ophthalmic optics - Ophthalmic viscosurgical devices
- YY/T 1553-2017Cardiovascular implants-Cardiac occluder
- YY/T 1571-2017Tissue engineering medical device products—Sodium hyaluronate
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Related Standards
GB 18279.1-2015 — Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 11118-2026 — Hydraulic fluids (L-HL, L-HM, L-HV, L-HS and L-HG type)
GB 11557-2026 — Provisions for protecting drivers from injury by the steering mechanism of motor vehicles
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GB 18279-2000
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