2025-12-21 216.73.216.41
Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
Position: Search valid to be valid superseded to be superseded abolished to be abolished
Standard No. Title Price(USD) Delivery Status Add to Cart
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 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
T/CSBME 005-2019 Medical teaching trauma simulators -Part 1: General technical requirements for models 300.0 via email in 1~3 business day valid,,2019-8-1
YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process 140.0 via email in 1~3 business day valid,,2018-7-1
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
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
DB44/T 2032-2017 Test Methods of Electromagnetic Compatibility In-situ for Large Medical Equipment or System via email in business day abolished2025-08-31,,2017-11-28
YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes 140.0 via email in 1 business day valid,,2017-5-1
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation 170.0 via email in 1 business day superseded,2023-5-1,2017-4-1
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
YY/T 1292.3-2016 Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity test 154.0 via email in 1~3 business day valid,,2017-1-1
YY/T 0316-2016 Medical devices-Application of risk management to medical devices 400.0 via email in 1 business day valid,,2017-1-1
YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software 690.0 via email in 1~5 business day valid,,2017-1-1
YY/T 1465.2-2016 Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) 110.0 via email in 1~3 business day valid,,2017-1-1
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 140.0 via email in 1 business day superseded,2025-9-15,2017-1-1
YY/T 1465.1-2016 Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro 110.0 via email in 1~3 business day valid,,2017-1-1
YY 0945.2-2015 Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source 310.0 via email in 1~5 business day to be superseded,2026-5-1,2017-1-1
YY/T 0869.1-2016 Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes 250.0 via email in 1~3 business day valid,,2017-1-1
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 220.0 via email in 1~3 business day superseded,2024-7-1,2017-1-1
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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 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
T/CSBME 005-2019 Medical teaching trauma simulators -Part 1: General technical requirements for models 
  Issued on: 2019-07-11   Price(USD): 300.0
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   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   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   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   Price(USD):
YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes  
  Issued on: 2017-01-19   Price(USD): 140.0
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation 
  Issued on: 2015-12-10   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   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   Price(USD): 154.0
YY/T 0316-2016 Medical devices-Application of risk management to medical devices 
  Issued on: 2016-01-26   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   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   Price(USD): 110.0
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 
  Issued on: 2016-01-26   Price(USD): 140.0
YY/T 1465.1-2016 Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro 
  Issued on: 2016-01-26   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   Price(USD): 310.0
YY/T 0869.1-2016 Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes 
  Issued on: 2016-01-26   Price(USD): 250.0
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 
  Issued on: 2016-01-26   Price(USD): 220.0
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