| Title |
Standard No. |
Implemented On |
| Plasma quick-freezer | T/CSBME 022-2020 | |
| Aseptic processing of health care products-Part 2:Sterilizing filtration | YY/T 0567.2-2021 | 2022-4-1 |
| Processing of medical devices—Information to be provided by the medical device manufacturer | YY/T 0802-2020 | 2021-12-1 |
| Analytical method for bioburden control level of medical device | YY/T 1737-2020 | 2021-9-1 |
| General technical specification of mobile nucleic acid detecting laboratory | T/CIQA 17-2021 | 2021-4-1 |
| General technical specification of nucleic acid detecting laboratory cabin | T/CIQA 16-2021 | 2021-4-1 |
| Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials | GB 4793.4-2019 | 2021-1-1 |
| Disinfector employing hot water | YY/T 1687-2019 | 2020-10-1 |
| Technical requirements for IoT of medical institution asset management | T/GZBC 38-2020 | 2020-9-1 |
| Washer-disinfector―Part 3:Washer-disinfectors employing thermal disinfection for human waste containers―Requirements and tests | YY/T 0734.3-2018 | 2020-1-1 |
| Washer-disinfectors―Part 2:Washer-disinfectors employing thermal disinfection for surgical instruments, anaestetic equipment,etc.―Requirements and tests | YY/T 0734.2-2018 | 2020-1-1 |
| Washer-disinfectors—Part 1:General requirements and tests | YY/T 0734.1-2018 | 2019-11-1 |
| Vertical steam sterilizers | YY/T 1007-2018 | 2019-10-1 |
| Quality test method of steam in medical sterilization process | YY/T 1612-2018 | 2019-10-1 |
| Requirements for process characterization and control in radiation sterilization of medical devices | YY/T 1613-2018 | 2019-10-1 |
| Medical steam generators | YY/T 0791-2018 | 2019-10-1 |
| Test method of effectiveness of sterilization processes for reusable medical devices | YY/T 1623-2018 | 2019-9-26 |
| Endoscopes washer-disinfectors | GB/T 35267-2017 | 2019-7-1 |
| Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits | YY/T 1608-2018 | 2019-7-1 |
| Cassette steam sterilizer | YY/T 1609-2018 | 2019-7-1 |
| Radiation sterilization of medical device—Method of dose setting | YY/T 1607-2018 | 2019-7-1 |
| 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 | GB/T 19974-2018 | 2019-6-1 |
| Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process | GB/T 19973.2-2018 | 2019-4-1 |
| Product family and processing category for steam sterilization of medical devices | YY/T 1600-2018 | 2019-1-1 |
| Sterilization of health care products—Biological indicators—Guidance for the selection,use and interpretation of results | GB/T 19972-2018 | 2018-10-1 |
| Low temperature steam and formaldehyde sterilizers for medical purposes | YY/T 0679-2016 | 2018-6-1 |
| Endoscopic washing station | YY 0992-2016 | 2018-1-1 |
| Ethylene oxide sterilizer | YY 0503-2016 | 2018-1-1 |
| Sterilization of health care products―Radiation―Part 3:Guidance on dosimetric aspects | GB/T 18280.3-2015 | 2018-1-1 |
| Portable mode steam sterilizers | YY 0504-2016 | 2018-1-1 |
| Steam sterilizer―Performance requirements of biosafety | YY 1277-2016 | 2018-1-1 |
| Dry heat (heated air) sterilizers | YY 1275-2016 | 2018-1-1 |
| Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices | GB 18280.1-2015 | 2017-7-1 |
| Sterilization of health care products―Radiation―Part 2:Establishing the sterilization dose | GB 18280.2-2015 | 2017-7-1 |
| Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1 | GB/T 18279.2-2015 | 2017-7-1 |
| Sterility test method for membrane filters | YY/T 1479-2016 | 2017-6-1 |
| Traceability information of disinfection and sterilization reusable medical devices | YY/T 1478-2016 | 2017-6-1 |
| Microbiological test method for demonstrating cleaning and disinfecting efficacy | YY/T 1495-2016 | 2017-6-1 |
| Requirements for the development,validation and routine control of dry heat sterilization process for medical devices | YY/T 1276-2016 | 2017-1-1 |
| Technical requirements and test methods of pharmaceutical cool refrigerator | WB/T 1062-2016 | 2017-1-1 |
| Sterilization of health care products―Biological indicators―Part 3:Biological indicators for moist heat sterilization processes | GB 18281.3-2015 | 2017-1-1 |
| Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization | YY/T 1402-2016 | 2017-1-1 |
| terilization of health care products—Biological indicator—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes | GB 18281.5-2015 | 2017-1-1 |
| Sterilization of health care products―Biological indicators―Part 4:Biological indicators for dry heat sterilization processes | GB 18281.4-2015 | 2017-1-1 |
| Sterilization of health care products—Biological indicators—Part 1: General requirements | GB 18281.1-2015 | 2017-1-1 |
| Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices | GB 18279.1-2015 | 2017-1-1 |
| Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites | YY/T 1463-2016 | 2017-1-1 |
| Sterilization of health care products―Biological indicators―Part 2:Biological indicators for ethylene oxide sterilization processes | GB 18281.2-2015 | 2017-1-1 |
| Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices | GB 18278.1-2015 | 2017-1-1 |
| Washer-disinfectors—Part 4:Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices,etc. | YY/T 0734.4-2016 | 2017-1-1 |
| Sterilization of health care products―Chemical indicator―Part 1:General requirements | GB 18282.1-2015 | 2017-1-1 |
| Sterilization of health care products—Chemical indicators—Part 5：Class 2 indicators for Bowie and Dick-type air removal tests | GB 18282.5-2015 | 2017-1-1 |
| Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices | YY/T 1464-2016 | 2017-1-1 |
| Sterilization of health care products―Chemical indicators―Guidance for selection,use and interpretion of results | GB/T 32310-2015 | 2016-9-1 |
| Sterilization of health care products―Vocabulary | GB/T 19971-2015 | 2016-9-1 |
| Packaging for terminally sterilized medical devices―Part 2:Validation requirements for forming,sealing and assembly processes | GB/T 19633.2-2015 | 2016-9-1 |
| Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems | GB/T 19633.1-2015 | 2016-9-1 |
| Sterilization of medical devices―Microbiological methods―Part 1:Determination of a population of microorganisms on products | GB/T 19973.1-2015 | 2016-9-1 |
| Evaluation of materials of medical device subject to ozone sterilization | YY/T 1264-2015 | 2016-1-1 |
| Evaluation of materials of medical device subject to hydrogen peroxide sterilization | YY/T 1266-2015 | 2016-1-1 |
| Evaluation of materials of medical device subject to dry heat sterilization | YY/T 1263-2015 | 2016-1-1 |
| Standard for Medical air disinfecting and cleaning machine | T/CPAM 001-2015 | 2016-1-1 |
| Product adoption and process equivalence for ethylene oxide sterilization | YY/T 1268-2015 | 2016-1-1 |
| Laundry Specification for hospital fabric treatment | SZDB/Z 125-2015 | 2015-2-1 |
| Evaluation of materials of health care product subject to radiation sterilization | YY/T 0884-2013 | 2014-10-1 |
| Aseptic processing of health care products - Part 1: General requirements | YY/T 0567.1-2013 | 2014-10-1 |
| Spring type release on pressure steam sterilizer | YY/T 0157-2013 | 2014-10-1 |
| Gasket ring on pressure steam sterilizer | YY/T 0158-2013 | 2014-10-1 |
| Spring full lift safety valves on pressure steam sterilizer | YY 0154-2013 | 2014-10-1 |
| Specification of process challenge devices and indicator systems for steam penetration testing | YY/T 0883-2013 | 2014-10-1 |
| Aseptic processing of health care products—Part 5:Sterilization in place | YY/T 0567.5-2011 | 2013-6-1 |
| Aseptic processing of health care products—Part 6:Isolator systems | YY/T 0567.6-2011 | 2013-6-1 |
| Ethylene oxide liquefied gas for sterilization | YY/T 0822-2011 | 2013-6-1 |
| Aseptic processing of health care products—Part 4:Clean-in-place technologies | YY/T 0567.4-2011 | 2013-6-1 |
| Steam generators for medical use | YY 0791-2010 | 2012-6-1 |
| Vertical mode steam sterilizers | YY 1007-2010 | 2012-6-1 |
| Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices | YY/T 0802-2010 | 2012-6-1 |
| Strength calculation and relevant regulations of primary pressure containing parts for rectangular pressure steam-heated sterilizer | YY/T 0084.2-2009 | 2010-12-1 |
| Washer-disinfector - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers | YY/T 0734.3-2009 | 2010-12-1 |
| 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 18282.4-2009 | 2010-12-1 |
| Large steam sterilizers—Manual control type | YY 0731-2009 | 2010-12-1 |
| Washer-disinfectors—Part 1:General requirements,terms and definitions and tests | YY/T 0734.1-2009 | 2010-12-1 |
| sher-disinfectors—Part 2:Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments,anaestetic equipment,etc. | YY/T 0734.2-2009 | 2010-12-1 |
| GB 18282.3-2009 | GB 18282.3-2009 | 2010-12-1 |
| Strength calculation and relevant regulations of primary pressure components of cylindrical pressure steam sterilizer | YY/T 0084.1-2009 | 2010-12-1 |
| Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizers | YY 0679-2008 | 2010-6-1 |
| medicinal ozone disinfecting cabinet | YY 0215-2008 | 2010-6-1 |
| Sterilization of health care products—Biological and chemical indicators—Test equipment | GB/T 24628-2009 | 2010-5-1 |
| Small steam sterilizers—Automatic type | YY 0646-2008 | 2009-12-1 |
| Technical requirements for large steam sterilizers - Automatic type | GB 8599-2008 | 2009-12-1 |
| Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the trea | GB 4793.8-2008 | 2009-1-1 |
| Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices | YY/T 0615.2-2007 | 2008-3-1 |
| Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices | YY/T 0615.1-2007 | 2008-3-1 |
| Pharmaceutical Refrigerator | YY/T 0086-2007 | 2008-3-1 |
| Blood refrigerator | YY/T 0168-2007 | 2008-3-1 |
| aids manipulated by both arms―Requirements and test methods―Part 1: Walking frames | GB/T 14728.1-2006 | 2006-12-1 |
| Vertical mode steam sterilizers | YY 1007-2005 | 2006-12-1 |
| Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities | GB/T 20367-2006 | 2006-10-1 |
| Sterilization of health care products-Vocabulary | GB/T 19971-2005 | 2006-4-1 |
| GB/T 1997 4-2005 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization proce | GB/T 19974-2005 | 2006-4-1 |
| GB/T 1997 4-2005 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization proce | GB/T 1997 4-2005 | 2006-4-1 |
| Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results | GB/T 19972-2005 | 2006-4-1 |
| GB/T 1997 3.2-2005 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process | GB/T 1997 3.2-2005 | 2006-4-1 |
| Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the validation of a sterilization process | GB/T 19973.2-2005 | 2006-4-1 |
| Portable Mode Steam Sterilizers | YY 0504-2005 | 2006-4-1 |
| Aseptic processing of health care products - Part 2: Filtration | YY/T 0567.2-2005 | 2006-1-1 |
| Ethylene oxide sterilizer | YY 0503-2005 | 2006-1-1 |
| Steam trap fitted on pressure steam sterilizer | YY/T 0159-2005 | 2006-1-1 |
| General Principles of Disinfection for Infections foci | GB 19193-2003 | 2003-12-1 |
| Sterilizer of large capacity infusion and small capacity infusion | JB 20001-2003 | 2003-6-1 |
| Sterilization of health care products--Biological indicators--Part 1:General | GB 18281.1-2000 | 2001-5-1 |
| Medical devices--Validation and routine control of ethylene oxide sterilization | GB 18279-2000 | 2001-5-1 |
| Sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilization | GB 18281.3-2000 | 2001-5-1 |
| Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization | GB 18280-2000 | 2001-5-1 |
| Sterilization of health care products--Chemical indicators--Part 1:General requirements | GB 18282.1-2000 | 2001-5-1 |
| Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization | GB 18278-2000 | 2001-5-1 |
| Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization | GB 18281.2-2000 | 2001-5-1 |
| General specification for medical oxygen generator with molecular sieve | YY/T 0298-1998 | 1998-10-1 |
| Inspecting method for sterilizing effect of automated autoclave sterilizer | GB/T 8600-1988 | 1988-7-1 |
| Specifications for automated autoclave sterilizer | GB 8599-1988 | 1988-7-1 |
| Specifications for portable steam sterilizers | GB 4027.1-1983 | 1984-9-1 |
| Specifications for portable steam sterilizers | YY 91006-1999 | 1984-9-1 |
