2025-12-19 216.73.216.41
Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
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Standard No. Title Price(USD) Delivery Status Add to Cart
YY/T 0878.3-2019 Test for complement activation of medical devices―Part 3：Assay for the product of complement activation (C3a and SC5b-9) 165.0 via email in 1~3 business day valid,,2020-8-1
YY/T 0870.6-2019 Test for genotoxicity of medical devices―Part 6:In vitro mammalian cell micronucleus test 255.0 via email in 1~3 business day valid,,2020-8-1
YY/T 0870.3-2019 Test for genotoxicity of medical devices―Part 3:TK gene mutation test using mouse lymphoma cells 315.0 via email in 1~5 business day valid,,2020-8-1
YY/T 1681-2019 Basic terms of unique device identification system 120.0 via email in 1~3 business day valid,,2020-8-1
YY/T 0595-2020 Medical devices—Quality management systems—Guidance on the application of YY/T 0287-2017 1170.0 via email in 1 business day valid,,2020-4-1
YY/T 1630-2018 Fundamental requirements for unique device identifier 120.0 via email in 1 business day valid,,2020-1-1
YY/T 1649.2-2019 Test method for interactions of medical devices with platelet — Part2 : In vitro platelet activation products ( β -TG, PF4 and TxB2 ) assay 140.0 via email in 1~5 business day valid,,2020-10-1
YY/T 0870.2-2019 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test 255.0 via email in 1~3 business day valid,,2020-6-1
YY/T 1651.1-2019 Tests for hemolysis of medical devices—Part 1:Material induced hemolysis assay 165.0 via email in 1~3 business day valid,,2020-6-1
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 valid,,2020-6-1
YY/T 0869-2013 Medical devices—Coding structure for adverse event type and cause 210.0 via email in 1~3 business day superseded,2017-1-1,2014-10-1
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,,2018-1-1
GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys 140.0 via email in 1~3 business day superseded,2024-1-1,2003-8-1
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,,2018-1-1
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 120.0 via email in 1 business day superseded,2023-5-1,2011-12-1
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 superseded2017-01-01,2017-1-1,2002-2-1
YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 310.0 via email in 1~5 business day valid,,2017-1-1
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,2003-8-1,1997-12-1
YY 0001-2008 Technical requirements of equipment for extracorporeally induced lithotripsy 100.0 via email in 1 business day valid,,2009-12-1
YY/T 0708-2009 dical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systems 240.0 via email in 1 business day abolished2023-05-01,,2010-12-1
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YY/T 0878.3-2019 Test for complement activation of medical devices―Part 3：Assay for the product of complement activation (C3a and SC5b-9) 
  Issued on: 2019-07-24   Price(USD): 165.0
YY/T 0870.6-2019 Test for genotoxicity of medical devices―Part 6:In vitro mammalian cell micronucleus test 
  Issued on: 2019-07-24   Price(USD): 255.0
YY/T 0870.3-2019 Test for genotoxicity of medical devices―Part 3:TK gene mutation test using mouse lymphoma cells 
  Issued on: 2019-07-24   Price(USD): 315.0
YY/T 1681-2019 Basic terms of unique device identification system 
  Issued on: 2019-07-24   Price(USD): 120.0
YY/T 0595-2020 Medical devices—Quality management systems—Guidance on the application of YY/T 0287-2017 
  Issued on: 2020-02-21   Price(USD): 1170.0
YY/T 1630-2018 Fundamental requirements for unique device identifier 
  Issued on: 2018-12-20   Price(USD): 120.0
YY/T 1649.2-2019 Test method for interactions of medical devices with platelet — Part2 : In vitro platelet activation products ( β -TG, PF4 and TxB2 ) assay 
  Issued on: 2019-10-23   Price(USD): 140.0
YY/T 0870.2-2019 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test 
  Issued on: 2019-05-31   Price(USD): 255.0
YY/T 1651.1-2019 Tests for hemolysis of medical devices—Part 1:Material induced hemolysis assay 
  Issued on: 2019-05-31   Price(USD): 165.0
YY/T 1649.1-2019 Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assay 
  Issued on: 2019-05-31   Price(USD): 105.0
YY/T 0869-2013 Medical devices—Coding structure for adverse event type and cause 
  Issued on: 2013-10-21   Price(USD): 210.0
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing 
  Issued on: 2017-02-28   Price(USD): 495.0
GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys 
  Issued on: 2003-03-05   Price(USD): 140.0
YY/T 1292.4-2017 Test for reproductive and developmental toxicity of medical devices- Part 4:Two-generation reproductive toxicity test 
  Issued on: 2017-02-28   Price(USD): 195.0
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 
  Issued on: 2011-6-16   Price(USD): 120.0
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 
  Issued on: 2001-9-24   Price(USD): 450.0
YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 
  Issued on: 2016-01-26   Price(USD): 310.0
GB/T 16886.5-1997 Biological evaluation of medical devices--Part 5:Tests for cytotoxicity:in vitro methods 
  Issued on: 1997-06-26   Price(USD): 165.0
YY 0001-2008 Technical requirements of equipment for extracorporeally induced lithotripsy 
  Issued on: 2008-04-25   Price(USD): 100.0
YY/T 0708-2009 dical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systems 
  Issued on: 2009-11-25   Price(USD): 240.0
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