YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices (English Version)
This standard specifies the requirements for the development, validation and routine control of low-temperature steam formaldehyde sterilization processes for medical devices. This standard applies to the sterilization of medical devices by process developers, sterilization equipment manufacturers, manufacturers of sterilized medical devices and units responsible for sterilization of medical devices (see Table E.1 in GB/T 19974-2005) . This standard covers sterilization processes that use mixed low-temperature steam formaldehyde as a sterilizing agent and operate only at pressures below ambient. Not applicable This standard does not specify requirements for the development, validation and routine control of pathogen inactivation processes for spongiform encephalopathies (such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease). Some countries have special regulations for handling materials potentially contaminated with these pathogens. This standard does not detail specific requirements for medical devices labeled "sterile". This standard does not specify a quality management system that controls all stages of medical device production. This standard does not specify occupational safety requirements related to the design and operation of low-temperature steam formaldehyde sterilization facilities. This standard does not cover analytical methods for determining the levels or residues of formaldehyde and/or its reaction products. This standard does not include some pre-treatment work required before sterilization, such as cleaning, disinfection and packaging.
YY/T 1464-2016 Referenced Document
GB 18281.1-2015 Sterilization of health care products.Biological indicators.Part 1:General requirements
GB 18281.5-2015 Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam*， 2017-01-01 Update
GB 18282.1-2015 Chemical indicators for sterilization of healthcare products - part 1: general rules*， 2017-01-01 Update
GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
GB/T 19973.2-2005 Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
YY 0679-2008 Sterilizers for medical purposes.Low temperature steam and formaldehyde sterilizers
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
YY/T 1464-2016 history
2022YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
2016YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices