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 (English Version)
This standard specifies the characteristics of sterilizing factors and the general requirements for the development, validation and routine control of the sterilization process of medical devices. This standard applies to sterilization processes that inactivate microorganisms by physical or chemical methods. This International Standard is to be used by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and organizations responsible for the sterilization of medical devices. This International Standard specifies the elements of a quality management system that should ensure appropriate characterization of sterilizing agents, development, validation, routine monitoring and control of the sterilization process. This standard does not apply to processes that rely solely on physical methods to remove bacteria (such as filtration). This standard does not specify specific inspection steps for microbial inactivation evaluation. This standard does not specify the characteristics of sterilizing factors and the development, validation and routine control requirements of the inactivation process of spongiform encephalopathy pathogens, for example: sheep scrapie, bovine spongiform encephalopathy, Creutzfeldt-Jakob disease. In particular, some countries have recommended special methods for the handling of materials potentially contaminated with such agents. This standard does not replace or modify published standards for specific sterilization processes.
GB/T 19974-2018 Referenced Document
GB 18282.1-2015 Chemical indicators for sterilization of healthcare products - part 1: general rules
GB 4793.4-2001 Safety requirements for electrical equipment for measurement,control and laboratory use Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory process
GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
GB/T 19022-2003 Measurement management systems-Requirements for measurement processes and measruing equipment
GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
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
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
GB/T 19974-2018 history
2018GB/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
2005GB/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