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Title Standard No. Implemented On
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management processYY/T 1512-20172018-7-1
Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testingYY/T 0618-20172018-1-1
Test for reproductive and developmental toxicity of medical devices- Part 4:Two-generation reproductive toxicity testYY/T 1292.4-20172018-1-1
Biological evaluation of medical devices―Part 6:Tests for local effects after implantationGB/T 16886.6-20152017-4-1
Medical devices—Guidance on the applicantion of ISO 14971YY/T 1437-20162017-1-1
Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay)YY/T 1465.2-20162017-1-1
Medical devices-Application of risk management to medical devicesYY/T 0316-20162017-1-1
Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power sourceYY 0945.2-20152017-1-1
Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity testYY/T 1292.3-20162017-1-1
Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devicesYY/T 0467-20162017-1-1
Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitroYY/T 1465.1-20162017-1-1
Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device softwareYY/T 1406.1-20162017-1-1
Test for reproductive and developmental toxicity of medical devices―Part 1:Screening testYY/T 1292.1-20152016-1-1
Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity testYY/T 1292.2-20152016-1-1
Test for complement activation of medical devices―Part 2:Serum alternative pathway complement activationYY/T 0878.2-20152016-1-1
Test for genotoxicity of medical devices―Part 5:Mammalian bone marrow chromosome aberration testYY/T 0870.5-20142015-7-1
Test for genotoxicity of medical devices―Part 4:Mammalian bone marrow erythocyte micronucleus testYY/T 0870.4-20142015-7-1
Complement activation test for medical devices - Part 1: Serum complement activationYY/T 0878.1-20132014-10-1
Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell YY/T 0870.3-20132014-10-1
Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration testYY/T 0870.2-20132014-10-1
Medical devices—Coding structure for adverse event type and causeYY/T 0869-20132014-10-1
Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation testYY/T 0870.1-20132014-10-1
Test for sensitization of medical devices - Part 1: Murine local lymph node assay (LLNA), radioisotope incorporation method YY/T 0879.1-20132014-10-1
Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materialsGB/T 16886.19-20112012-5-1
Biological evaluation of medical devices—Part 2:Animal welfare requirementsGB/T 16886.2-20112012-5-1
Biological evaluation of medical devices—Part 11:Tests for systemic toxicityGB/T 16886.11-20112012-5-1
Biological evaluation of medical devices—Part 18:Chemical characterization of materialsGB/T 16886.18-20112012-5-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processGB/T 16886.1-20112011-12-1
dical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systemsYY/T 0708-20092010-12-1
cal electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsYY 0709-20092010-12-1
Ultrasonics—Dental descaler systems—Measurement and declaration of the output characteristicsYY/T 0751-20092010-12-1
Electric apparatus for gastric lavageYY 1105-20082009-12-1
Medical electrical equipment—Part 2-41:Particular requirements for the safety of surgical luminaries and luminaries for diagnosisYY 0627-20082009-12-1
Technical requirements of equipment for extracorporeally induced lithotripsyYY 0001-20082009-12-1
Medical devices - Application of risk management to medical devicesYY/T 0316-20082009-12-1
Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testingYY/T 0618-20072008-3-1
Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003YY/T 0595-20062007-5-1
Medical devices - Quality management systems - Requirements for regulatory purposesYY/T 0287-20032004-4-1
Medical devices -- Symbols to be used with medical device labels labelling and information to be suppliedYY 0466-20032004-1-1
Medical devices -- Application of risk management to medical devicesYY/T 0316-20032004-1-1
Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devicesYY/T 0467-20032004-1-1
Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy GB 9706.22-20032003-12-1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with bloodGB/T 16886.4-20032003-8-1
Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramicsGB/T 16886.14-20032003-8-1
Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloysGB/T 16886.15-20032003-8-1
Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devicesGB/T 16886.13-20012002-2-1
Biological evaluation of medical devices--Part 1:Evaluation and testingGB/T 16886.1-20012002-2-1
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation productsGB/T 16886.9-20012002-2-1
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsGB/T 16886.7-20012002-2-1
Biological evaluation of medical devices--Part 5:Tests for cytotoxicity:in vitro methodsGB/T 16886.5-19971997-12-1
Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicityGB/T 16886.3-19971997-12-1
Biological evaluation of medical devices--Part 6:Tests for local effects after implantationGB/T 16886.6-19971997-12-1
Biological evaluation of medical devices --Part 1:Guidance on selection of testsGB/T 16886.1-19971997-12-1
Biological evaluation of medical devices--Part 11: Tests for systemic toxicityGB/T 16886.11-19971997-1-2
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