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Title Standard No. Implemented On
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
Ethylene oxide sterilization safety and effectiveness basic supply requirementsYY/T 1544-20172018-4-1
Sterilization of health care products―Radiation―Part 3:Guidance on dosimetric aspectsGB/T 18280.3-20152018-1-1
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
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
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 medical devices―Microbiological methods―Part 1:Determination of a population of microorganisms on productsGB/T 19973.1-20152016-9-1
Ultraviolet equipment for water disinfection―Ultraviolet dose testing methodGB/T 32091-20152016-5-1
Physical requirements and microbiological performance of ethylene oxide sterilization―Part 2:Microbiological aspectsYY/T 1302.2-20152016-1-1
Evaluation of materials of medical device subject to ozone sterilizationYY/T 1264-20152016-1-1
Evaluation of materials of medical device subject to ethylene oxide sterilizationYY/T 1267-20152016-1-1
Evaluation of materials of medical device subject to hydrogen peroxide sterilizationYY/T 1266-20152016-1-1
Evaluation of materials of medical device subject to moist heat sterilizationYY/T 1265-20152016-1-1
Evaluation of materials of medical device subject to dry heat sterilizationYY/T 1263-20152016-1-1
Physical requirements and microbiological performance of ethylene oxide sterilization—Part 1: Physical aspectsYY/T 1302.1-20152016-1-1
Product adoption and process equivalence for ethylene oxide sterilizationYY/T 1268-20152016-1-1
Needleless access ports for fluid lines and blood lines―Test method for microbial ingressYY/T 0923-20142015-7-1
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
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
Aseptic processing of health care products—Part 3:LyophilizationYY/T 0567.3-20112013-6-1
Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devicesYY/T 0802-20102012-6-1
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
GB 18282.3-2009GB 18282.3-20092010-12-1
Sterilization of health care products—Biological and chemical indicators—Test equipmentGB/T 24628-20092010-5-1
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
GB/T 1997 3.1-2005 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on productsGB/T 1997 3.1-20052006-4-1
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
Sterilization of medical devices─Microbiological methods―Part 1:Estimation of population of microorganisms on productsGB/T 19973.1-20052006-4-1
Aseptic processing of health care products - Part 2: FiltrationYY/T 0567.2-20052006-1-1
Sterilization of health care products--Biological indicators--Part 1:GeneralGB 18281.1-20002001-5-1
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--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
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