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 (English Version)
- Standard No.
- GB/T 19974-2005
- Language
- Chinese, Available in English version
- Release Date
- 2005
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2019-06
- Replace By
- GB/T 19974-2018
- Latest
- GB/T 19974-2018
- Scope
- 1.1 This standard describes the characteristics of sterilizing factors and the general requirements for the setting, validation and routine control of medical device sterilization processes. 1.2 This standard applies to sterilization processes that inactivate microorganisms by physical or chemical methods. 1.3 This standard does not apply to processes that rely solely on physical methods to remove bacteria (such as filtration). 1.4 This standard does not describe the specific test steps for microbial inactivation evaluation. 1.5 This International Standard is intended to be used by process developers, manufacturers of sterilization equipment, manufacturers of non-sterile medical devices, and organizations responsible for the sterilization of medical devices. 1.6 This standard does not replace or modify published standards for specific sterilization processes.
GB/T 19974-2005 Referenced Document
- GB 18281.1 Sterilization of health care products.Biological indicators.Part 1:General requirements*， 2015-12-10 Update
- GB 18282.1 Chemical indicators for sterilization of healthcare products - part 1: general rules*， 2017-01-01 Update
- GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements*， 2007-06-07 Update
- GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
- GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
GB/T 19974-2005 history
- 2018 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
- 2005 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
