GB 27955-2020 Translated English of Chinese Standard. (GB 27955-2020, GB27955-2020): Hygienic Requirements for Low-Temperature Hydrogen Peroxide Gas Plasma Sterilizer [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 2020. 8. 13. - 22ÆäÀÌÁö This Standard specifies the technical requirements, application range, precautions for use, inspection rules, inspection methods, marking and packaging, transportation and storage for the low-temperature hydrogen peroxide gas plasma sterilizer. This Standard is applicable to low-temperature hydrogen peroxide gas plasma sterilizers for sterilizing medical devices, appliances and articles that are not resistant to humidity and high temperature. |
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3 | |
Scope | 5 |
Terms and Definitions | 6 |
Application Range | 9 |
Precautions for Use | 10 |
Marking and Packaging | 13 |
Appendix A Normative Test Methods of Sterilization Effect | 14 |
Appendix B Normative Biological Monitoring Method for LowTemperature Hydrogen Peroxide Gas Plasma Sterilization | 18 |
Normative Preparation Method of Test Sample | 20 |
Normative Material Compatibility Test | 21 |
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Appendix bacillus stearothermophilus spores bacterial growth Biocompatibility biological monitoring package Blow dry chamber see Figure Clause concentration of hydrogen conditioning stage Connect the pressure culture results cycle to determine cytotoxicity test Disinfection 2002 Edition display device equipment Evaluation of Medical gas plasma sterilizer hydrogen peroxide concentration hydrogen peroxide gas hydrogen peroxide sterilant inner wall layer of shelf Low-Temperature Hydrogen Peroxide lower layers luminal biological PCD manufacturer manufacturer's instruction manual manufacturer's provisions Material Compatibility Medical Devices metal and non-metal method specified minimum value specified negative control non-luminal biological monitoring non-metal material Normative peroxide gas plasma peroxide is injected pressure measuring device pressure test port PTFE tubes purification Recording and output run the sterilization samples in accordance satisfies Shandong specified in GB/T Standard for Disinfection sterilization cycle sterilization effect sterilization program sterilization stage sterilized items sterilizer instruction manual stopwatch to measure Technical Standard Tryptone upper layer ventilation stage Zhang Zhejiang