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International Standard List: Medical equipment in general

YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process 
  Issued on: 2017-07-17   Translation Price(USD): 140.0
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing 
  Issued on: 2017-02-28   Translation Price(USD): 495.0
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   Translation Price(USD): 195.0
DB44/T 2032-2017 Test Methods of Electromagnetic Compatibility In-situ for Large Medical Equipment or System 
  Issued on: 2017-08-28   Translation Price(USD):
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation 
  Issued on: 2015-12-10   Translation Price(USD): 170.0
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   Translation Price(USD): 310.0
YY/T 1292.3-2016 Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity test 
  Issued on: 2016-01-26   Translation Price(USD): 154.0
YY/T 0316-2016 Medical devices-Application of risk management to medical devices 
  Issued on: 2016-01-26   Translation Price(USD): 400.0
YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software 
  Issued on: 2016-03-23   Translation Price(USD): 690.0
YY/T 1465.2-2016 Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) 
  Issued on: 2016-01-26   Translation Price(USD): 110.0
YY/T 1465.1-2016 Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro 
  Issued on: 2016-01-26   Translation Price(USD): 110.0
YY 0945.2-2015 Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source 
  Issued on: 2015-03-02   Translation Price(USD): 310.0
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 
  Issued on: 2016-01-26   Translation Price(USD): 220.0
YY/T 1292.1-2015 Test for reproductive and developmental toxicity of medical devices―Part 1:Screening test 
  Issued on: 2015-03-02   Translation Price(USD): 225.0
YY/T 0878.2-2015 Test for complement activation of medical devices―Part 2:Serum alternative pathway complement activation 
  Issued on: 2015-03-02   Translation Price(USD): 225.0
YY/T 1292.2-2015 Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity test 
  Issued on: 2015-03-02   Translation Price(USD): 225.0
YY/T 0870.5-2014 Test for genotoxicity of medical devices―Part 5:Mammalian bone marrow chromosome aberration test 
  Issued on: 2014-06-17   Translation Price(USD): 165.0
YY/T 0870.4-2014 Test for genotoxicity of medical devices―Part 4:Mammalian bone marrow erythocyte micronucleus test 
  Issued on: 2014-06-17   Translation Price(USD): 105.0
YY/T 0869-2013 Medical devices—Coding structure for adverse event type and cause 
  Issued on: 2013-10-21   Translation Price(USD): 210.0
YY/T 0870.3-2013 Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell  
  Issued on: 2013-10-21   Translation Price(USD): 180.0
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