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YY/T 0870.3-2013 Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell 180.0 via email in 1~3 business day valid
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/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 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials 260.0 via email in 1~3 business day valid
YY/T 0870.1-2013 Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation test 210.0 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/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes 400.0 via email in 1 business day abolished
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 180.0 via email in 1 business day valid
YY 0945.2-2015 Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source 315.0 via email in 1~5 business day valid
YY/T 0869-2013 Medical devices—Coding structure for adverse event type and cause 210.0 via email in 1~3 business day superseded
GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramics 140.0 via email in 1~3 business day valid
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 260.0 via email in 1~5 business day valid
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/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
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied 150.0 via email in 1~3 business day superseded
YY/T 0879.1-2013 Test for sensitization of medical devices - Part 1: Murine local lymph node assay (LLNA), radioisotope incorporation method 165.0 via email in 1~3 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 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
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