2026-4-2 216.73.216.113
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Position: Search valid to be valid superseded to be superseded abolished to be abolished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
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing 220.0 via email in 1~3 business day superseded2011-12-01,2011-12-1,2002-2-1
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,,2016-1-1
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evaluation of medical devices―Part 6:Tests for local effects after implantation 170.0 via email in 1 business day superseded,2023-5-1,2017-4-1
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 superseded2012-05-01,2012-5-1,1997-1-2
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices 300.0 via email in 1~3 business day superseded,2017-1-1,2004-1-1
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for the safety of external cardiac pacemakers with internal power source 310.0 via email in 1~5 business day to be superseded,2026-5-1,2017-1-1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 0709-2009 cal electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 480.0 via email in 1 business day superseded,2023-5-1,2010-12-1
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 160.0 via email in 1~3 business day superseded2018-07-01,2018-7-1,2002-2-1
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 130.0 via email in 1~3 business day superseded,2018-7-1,2002-2-1
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,,2016-1-1
YY 0627-2008 Medical electrical equipment—Part 2-41:Particular requirements for the safety of surgical luminaries and luminaries for diagnosis 450.0 via email in 1~3 business day superseded,1993-5-1,2009-12-1
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
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 superseded2008-09-01,2008-9-1,1997-12-1
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 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes 140.0 via email in 1 business day valid,,2017-5-1
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GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing 
  Issued on: 2001-09-24   Price(USD): 220.0
YY/T 0878.2-2015 Test for complement activation of medical devices―Part 2:Serum alternative pathway complement activation 
  Issued on: 2015-03-02   Price(USD): 225.0
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
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity 
  Issued on: 1997-06-26   Price(USD): 195.0
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices 
  Issued on: 2003-6-22   Price(USD): 300.0
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 0709-2009 cal electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 
  Issued on: 2009-12-25   Price(USD): 480.0
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 
  Issued on: 2001-9-24   Price(USD): 160.0
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 
  Issued on: 2001-9-24   Price(USD): 130.0
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   Price(USD): 225.0
YY 0627-2008 Medical electrical equipment—Part 2-41:Particular requirements for the safety of surgical luminaries and luminaries for diagnosis 
  Issued on: 2008-4-25   Price(USD): 450.0
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 
  Issued on: 2016-01-26   Price(USD): 220.0
GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity 
  Issued on: 1997-06-26   Price(USD): 165.0
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 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes  
  Issued on: 2017-01-19   Price(USD): 140.0
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