Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
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YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure 315.0 via email in 1~5 business day valid
YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process 205.0 via email in 1~3 business day valid
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing 495.0 via email in 1~5 business day valid
YY/T 1292.4-2017 Test for reproductive and developmental toxicity of medical devices- Part 4:Two-generation reproductive toxicity test 195.0 via email in 1~3 business day valid
GB/T 16886.5-1997 Biological evaluation of medical devices--Part 5:Tests for cytotoxicity:in vitro methods 165.0 via email in 1~3 business day superseded
YY/T 0878.1-2013 Complement activation test for medical devices - Part 1: Serum complement activation 150.0 via email in 1~3 business day valid
YY 1105-2008 Electric apparatus for gastric lavage 150.0 via email in 1~3 business day valid
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 150.0 via email in 1~3 business day abolished
YY/T 0870.5-2014 Test for genotoxicity of medical devices―Part 5:Mammalian bone marrow chromosome aberration test 165.0 via email in 1~3 business day valid
YY/T 0618-2007 Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing 345.0 via email in 1~5 business day superseded
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied 120.0 via email in 1~3 business day abolished
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials 240.0 via email in 1~3 business day valid
YY/T 1649.1-2019 Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assay 105.0 via email in 1~3 business day to be valid
YY 0627-2008 Medical electrical equipment—Part 2-41:Particular requirements for the safety of surgical luminaries and luminaries for diagnosis 450.0 via email in 1~3 business day superseded
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices 375.0 via email in 1~5 business day abolished
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 200.0 via email in 1~3 business day valid
YY/T 1465.2-2016 Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) 110.0 via email in business day valid
YY/T 0316-2016 Medical devices-Application of risk management to medical devices 670.0 via email in 1~10 business day valid
GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood 320.0 via email in 1 business day valid
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements 190.0 via email in 1~3 business day valid
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