This standard specifies test methods to demonstrate that a process challenge device is more difficult to achieve sterilization conditions than the medical device it simulates, with respect to outgassing and vapor penetration. This process challenge device is suitable for large sterilizers that meet the requirements of GB 8599-2008 and small sterilizers that meet the requirements of YY 0646-2008 (including type B cycles). Qualified process challenge devices in this standard are only valid for the medical device being simulated. This standard does not specify the design and materials of process challenge devices.
YY/T 1402-2016 Referenced Document
EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009
GB 18281.1 Sterilization of health care products.Biological indicators.Part 1:General requirements
GB 18281.3 Biological indicators for sterilization of healthcare products - Part 3: Biological indicators for moist heat sterilization*， 2017-01-01 Update
GB 18282.1 Chemical indicators for sterilization of healthcare products - part 1: general rules*， 2017-01-01 Update
GB 18282.4-2009 Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
GB 8599-2008 Technical requirements for large steam sterilizers.Automatic type
GB/T 19022-2003 Measurement management systems-Requirements for measurement processes and measruing equipment
GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 19972-2005 Sterilization of health care products.Biological indicators.Guidance for the selection, use and interpretation of results
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
GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories
ISO 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices*， 2024-03-01 Update
YY 0646-2008 Small steam sterilizers.automatic type
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
YY/T 1402-2016 history
2016YY/T 1402-2016 Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization