Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
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GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity 165.0 via email in 1~3 business day abolished
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requirements for the safety of surgical luminaries and luminaries for diagnosis 450.0 via email in 1~3 business day superseded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 1292.2-2015 Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity test 225.0 via email in 1~3 business day valid
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 115.0 via email in 1~3 business day to be superseded
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 to be abolished
YY 0709-2009 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 systems 680.0 via email in 1~5 business day valid
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices 300.0 via email in 1~3 business day abolished
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity 195.0 via email in 1~3 business day abolished
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation 210.0 via email in 1~5 business day valid
YY/T 0878.2-2015 Test for complement activation of medical devices―Part 2:Serum alternative pathway complement activation 225.0 via email in 1~3 business day valid
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing 225.0 via email in 1~3 business day abolished
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity 435.0 via email in 1~3 business day valid
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials 260.0 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
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied 130.0 via email in 1~3 business day abolished
YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements 360.0 via email in 1~5 business day valid
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements 200.0 via email in 1~3 business day valid
YY/T 0751-2009 Ultrasonics—Dental descaler systems—Measurement and declaration of the output characteristics 204.0 via email in 1~3 business day valid
YY/T 0870.2-2013 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test 210.0 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
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