GB/T 19973.2-2018Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (English PDF)
医疗器械的灭菌 微生物学方法 第2部分：用于灭菌过程的定义、确认和维护的无菌试验
GB/T 19973.2 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 19973.2-2025 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Valid |
| GB/T 19973.2-2018 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Obsolete |
GB/T 19973.2-2018 is obsolete. It has been replaced by GB/T 19973.2-2025. This page sells the obsolete edition, for projects and contracts that still cite it.
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China
Level / Type
National · Recommended
Issue date
March 15, 2018
Implementation date
April 1, 2019
Scope
GB/T 19973.2-2018 is the English-translated version of 医疗器械的灭菌 微生物学方法 第2部分：用于灭菌过程的定义、确认和维护的无菌试验.
GB/T 19973.2-2018 is the Chinese national standard "Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process".
It was issued on March 15, 2018 by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and the Standardization Administration of China, and took effect on April 1, 2019. It is obsolete: it has been replaced by GB/T 19973.2-2025.
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Document preview — GB/T 19973.2-2018
National Standard of the People's Republic of China
Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China
Contents
- Document data
1 Document data
Sector: National standard (Recommended).
Issuing body: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China.
Date of issue: 2018-03-15.
Date of implementation: 2019-04-01.
Status: obsolete, replaced by GB/T 19973.2-2025.
......
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 18280.1-2025Sterilization of health care products - Radiation - Part 1: Requirements for the development
- YY/T 1608-2018Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits
- YY/T 1402-2016Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization
- YY/T 1479-2016Sterility test method for membrane filters
- GB 18280.1-2015Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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Related Standards
GB/T 19973.1-2005 — Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products
GB/T 19973.1-2015 — Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
GB/T 19973.1-2023 — Sterilization of health care products--Microbiological methods - Part 1: Determination of a population of microorganisms on products
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GB/T 19973.2-2018
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