YY/T 1464-2022 Sterilization of health care products—Low temperature steam and formaldehyde—Requirements for development,validation and routine control of a sterilization process for medical devices

Scope

1.1.1 This document specifies the requirements for the development, validation, and routine control of the low-temperature steam formaldehyde sterilization process for medical devices. This document is applicable to the sterilization process using mixed low-temperature steam formaldehyde as a sterilization agent under negative pressure conditions.
Note: Although the scope of this document is limited to medical devices, the requirements specified and guidance provided herein can be applied to other products and equipment.
1.1.2 This document is intended for use by process developers, sterilization equipment manufacturers, manufacturers of sterile medical devices, and institutions responsible for the sterilization of medical devices (see Table E.1 in GB/T 19974—2018).
1.2 Not Applicable
1.2.1 This document is not applicable to the requirements for the development, validation, and routine control of the inactivation process for prion diseases (such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease) pathogens.
Note: See YY/T 0771.1, YY/T 0771.2, and YY/T 0771.3.
1.2.2 This document does not specify the specific requirements for labeling "sterile" medical devices.
1.2.3 This document does not specify the quality management system for controlling all stages of medical device production.
Note: This document does not specify the requirements for a complete quality management system necessary for equipment manufacturing or device reprocessing. It only specifies the basic elements of a quality management system necessary for controlling the sterilization process, which are normatively referenced in appropriate places in the text (see Chapter 4 in particular). For more guidance, see E.4 in GB/T 19974—2018.
1.2.4 This document does not specify occupational safety requirements related to the design and operation of low-temperature steam formaldehyde sterilization facilities.
Note: Operational s

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