GB/T 19974-2005Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices (English PDF)
医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求
GB/T 19974 | Evolution and historical versions
| Std ID | Title | Status |
|---|---|---|
| GB/T 19974-2018 | Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices | Valid |
| GB/T 19974-2005 | Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices | Obsolete |
GB/T 19974-2005 is obsolete. It has been replaced by GB/T 19974-2018. 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
November 4, 2005
Implementation date
April 1, 2006
Scope
GB/T 19974-2005 is the English-translated version of 医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求.
GB/T 19974-2005 is the Chinese national standard "Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices".
It was issued on November 4, 2005 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, 2006. It is obsolete: it has been replaced by GB/T 19974-2018.
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Document preview — GB/T 19974-2005
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: 2005-11-04.
Date of implementation: 2006-04-01.
Status: obsolete, replaced by GB/T 19974-2018.
......
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 12279.1-2024Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- GB/T 44138-2024Cardiovascular implants - Cardiovascular absorbable implants
- YY/T 1748-2021Neurovascular implants—Intracranial embolization coils
- YY/T 1787-2021Cardiovascular implants—Cardiac valve repair devices and delivery system
- YY/T 1804-2021Anaesthetic and respiratory equipment-Spirometers intended for the measurement of time forced expired volumes in humans
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