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Title Standard No. Implemented On
Endoscopes washer-disinfectorsGB/T 35267-20172019-7-1
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 devicesGB/T 19974-20182019-6-1
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition,validation and maintenance of a sterilization processGB/T 19973.2-20182019-4-1
Sterilization of health care products—Biological indicators—Guidance for the selection,use and interpretation of resultsGB/T 19972-20182018-10-1
Low temperature steam and formaldehyde sterilizers for medical purposesYY/T 0679-20162018-6-1
Endoscopic washing stationYY 0992-20162018-1-1
Ethylene oxide sterilizerYY 0503-20162018-1-1
Sterilization of health care products―Radiation―Part 3:Guidance on dosimetric aspectsGB/T 18280.3-20152018-1-1
Portable mode steam sterilizersYY 0504-20162018-1-1
Steam sterilizer―Performance requirements of biosafetyYY 1277-20162018-1-1
Dry heat (heated air) sterilizersYY 1275-20162018-1-1
Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devicesGB 18280.1-20152017-7-1
Sterilization of health care products―Radiation―Part 2:Establishing the sterilization doseGB 18280.2-20152017-7-1
Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1GB/T 18279.2-20152017-7-1
Sterility test method for membrane filtersYY/T 1479-20162017-6-1
Microbiological test method for demonstrating cleaning and disinfecting efficacyYY/T 1495-20162017-6-1
Requirements for the development,validation and routine control of dry heat sterilization process for medical devicesYY/T 1276-20162017-1-1
Technical requirements and test methods of pharmaceutical cool refrigeratorWB/T 1062-20162017-1-1
Sterilization of health care products―Biological indicators―Part 3:Biological indicators for moist heat sterilization processesGB 18281.3-20152017-1-1
Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilizationYY/T 1402-20162017-1-1
terilization of health care products—Biological indicator—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processesGB 18281.5-20152017-1-1
Sterilization of health care products―Biological indicators―Part 4:Biological indicators for dry heat sterilization processesGB 18281.4-20152017-1-1
Sterilization of health care products—Biological indicators—Part 1: General requirementsGB 18281.1-20152017-1-1
Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devicesGB 18279.1-20152017-1-1
Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sitesYY/T 1463-20162017-1-1
Sterilization of health care products―Biological indicators―Part 2:Biological indicators for ethylene oxide sterilization processesGB 18281.2-20152017-1-1
Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devicesGB 18278.1-20152017-1-1
Washer-disinfectors—Part 4:Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices,etc.YY/T 0734.4-20162017-1-1
Sterilization of health care products―Chemical indicator―Part 1:General requirementsGB 18282.1-20152017-1-1
Sterilization of health care products—Chemical indicators—Part 5:Class 2 indicators for Bowie and Dick-type air removal testsGB 18282.5-20152017-1-1
Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devicesYY/T 1464-20162017-1-1
Sterilization of health care products―Chemical indicators―Guidance for selection,use and interpretion of resultsGB/T 32310-20152016-9-1
Sterilization of health care products―VocabularyGB/T 19971-20152016-9-1
Packaging for terminally sterilized medical devices―Part 2:Validation requirements for forming,sealing and assembly processesGB/T 19633.2-20152016-9-1
Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systemsGB/T 19633.1-20152016-9-1
Sterilization of medical devices―Microbiological methods―Part 1:Determination of a population of microorganisms on productsGB/T 19973.1-20152016-9-1
Evaluation of materials of medical device subject to ozone sterilizationYY/T 1264-20152016-1-1
Evaluation of materials of medical device subject to hydrogen peroxide sterilizationYY/T 1266-20152016-1-1
Evaluation of materials of medical device subject to dry heat sterilizationYY/T 1263-20152016-1-1
Standard for Medical air disinfecting and cleaning machineT/CPAM 001-20152016-1-1
Product adoption and process equivalence for ethylene oxide sterilizationYY/T 1268-20152016-1-1
Laundry Specification for hospital fabric treatmentSZDB/Z 125-20152015-2-1
Evaluation of materials of health care product subject to radiation sterilizationYY/T 0884-20132014-10-1
Aseptic processing of health care products - Part 1: General requirementsYY/T 0567.1-20132014-10-1
Spring type release on pressure steam sterilizerYY/T 0157-20132014-10-1
Gasket ring on pressure steam sterilizerYY/T 0158-20132014-10-1
Spring full lift safety valves on pressure steam sterilizerYY 0154-20132014-10-1
Specification of process challenge devices and indicator systems for steam penetration testingYY/T 0883-20132014-10-1
Aseptic processing of health care products—Part 5:Sterilization in placeYY/T 0567.5-20112013-6-1
Aseptic processing of health care products—Part 6:Isolator systemsYY/T 0567.6-20112013-6-1
Ethylene oxide liquefied gas for sterilizationYY/T 0822-20112013-6-1
Aseptic processing of health care products—Part 4:Clean-in-place technologiesYY/T 0567.4-20112013-6-1
Steam generators for medical useYY 0791-20102012-6-1
Vertical mode steam sterilizersYY 1007-20102012-6-1
Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devicesYY/T 0802-20102012-6-1
Strength calculation and relevant regulations of primary pressure containing parts for rectangular pressure steam-heated sterilizerYY/T 0084.2-20092010-12-1
Washer-disinfector - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containersYY/T 0734.3-20092010-12-1
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 penetrationGB 18282.4-20092010-12-1
Large steam sterilizers—Manual control typeYY 0731-20092010-12-1
Washer-disinfectors—Part 1:General requirements,terms and definitions and testsYY/T 0734.1-20092010-12-1
sher-disinfectors—Part 2:Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments,anaestetic equipment,etc.YY/T 0734.2-20092010-12-1
GB 18282.3-2009GB 18282.3-20092010-12-1
Strength calculation and relevant regulations of primary pressure components of cylindrical pressure steam sterilizerYY/T 0084.1-20092010-12-1
Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizersYY 0679-20082010-6-1
medicinal ozone disinfecting cabinetYY 0215-20082010-6-1
Sterilization of health care products—Biological and chemical indicators—Test equipmentGB/T 24628-20092010-5-1
Small steam sterilizers—Automatic typeYY 0646-20082009-12-1
Technical requirements for large steam sterilizers - Automatic type GB 8599-20082009-12-1
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 treaGB 4793.8-20082009-1-1
Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devicesYY/T 0615.2-20072008-3-1
Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devicesYY/T 0615.1-20072008-3-1
Pharmaceutical RefrigeratorYY/T 0086-20072008-3-1
Blood refrigeratorYY/T 0168-20072008-3-1
aids manipulated by both arms―Requirements and test methods―Part 1: Walking framesGB/T 14728.1-20062006-12-1
Vertical mode steam sterilizersYY 1007-20052006-12-1
Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilitiesGB/T 20367-20062006-10-1
Sterilization of health care products-VocabularyGB/T 19971-20052006-4-1
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 proceGB/T 1997 4-20052006-4-1
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of resultsGB/T 19972-20052006-4-1
GB/T 1997 3.2-2005 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization processGB/T 1997 3.2-20052006-4-1
Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the validation of a sterilization processGB/T 19973.2-20052006-4-1
Portable Mode Steam SterilizersYY 0504-20052006-4-1
Aseptic processing of health care products - Part 2: FiltrationYY/T 0567.2-20052006-1-1
Ethylene oxide sterilizerYY 0503-20052006-1-1
Steam trap fitted on pressure steam sterilizerYY/T 0159-20052006-1-1
General Principles of Disinfection for Infections fociGB 19193-20032003-12-1
Sterilizer of large capacity infusion and small capacity infusionJB 20001-20032003-6-1
Sterilization of health care products--Biological indicators--Part 1:GeneralGB 18281.1-20002001-5-1
Medical devices--Validation and routine control of ethylene oxide sterilizationGB 18279-20002001-5-1
Sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilizationGB 18281.3-20002001-5-1
Sterilization of health care products—Requirement for validation and routine control—Radiation sterilizationGB 18280-20002001-5-1
Sterilization of health care products--Chemical indicators--Part 1:General requirementsGB 18282.1-20002001-5-1
Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilizationGB 18278-20002001-5-1
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilizationGB 18281.2-20002001-5-1
General specification for medical oxygen generator with molecular sieveYY/T 0298-19981998-10-1
Inspecting method for sterilizing effect of automated autoclave sterilizerGB/T 8600-19881988-7-1
Specifications for portable steam sterilizersYY 91006-19991984-9-1
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