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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
YY/T 0595-2006 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003 500.0 via email in 1~2 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 0751-2009 Ultrasonics—Dental descaler systems—Measurement and declaration of the output characteristics 240.0 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 165.0 via email in 1~3 business day valid
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 9706.22-2003 Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy 510.0 via email in 1~3 business day valid
YY/T 0316-2008 Medical devices - Application of risk management to medical devices 500.0 via email in 1~2 business day abolished
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 450.0 via email in 1~3 business day abolished
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials 270.0 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 270.0 via email in 1~3 business day valid
YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes 440.0 via email in 1 business day to be abolished
YY/T 0708-2009 dical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systems 420.0 via email in 1~5 business day valid
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 200.0 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 150.0 via email in 1~3 business day valid
GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys 180.0 via email in 1~3 business day valid
YY/T 0870.4-2014 Test for genotoxicity of medical devices―Part 4:Mammalian bone marrow erythocyte micronucleus test 105.0 via email in 1~3 business day valid
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