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

Scope

1.1.1 This standard specifies the general requirements for the development, validation, and routine control of the sterilization process of medical devices using sterilization factors.
Note: Although the scope of this standard is limited to medical devices, the requirements specified in this standard can also be applied to other healthcare products.
1.1.2 This standard applies to the sterilization process that inactivates microorganisms by physical or chemical methods.
1.1.3 This standard will 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.
1.1.4 This standard specifies the quality management system elements required to ensure the appropriate characteristics of sterilization factors, development, validation, routine monitoring, and control of the sterilization process.
Note: This standard does not require a complete quality management system. The necessary elements are normatively referenced in appropriate places in the main text (see Chapter 4). It should be noted that the quality management system standards for controlling all stages of medical device production or processing (see YY/T 0287) are applicable. National and/or regional regulations concerning the supply of medical devices may require the implementation of a complete quality management system and the evaluation of this system by a third party.

Development Information

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Referenced Standards

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