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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
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process 585.0 via email in 1 business day valid,,2023-5-1
GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization 800.0 via email in 1 business day to be superseded,2025-9-1,2018-7-1
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials 140.0 via email in 1 business day to be abolished2024-12-01,2024-12-1,2018-7-1
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials 315.0 via email in 1~5 business day to be valid,,2024-12-1
GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices 140.0 via email in 1~3 business day valid,,2018-7-1
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys 255.0 via email in 1~3 business day valid,,2024-1-1
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables 255.0 via email in 1~3 business day valid,,2022-12-1
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process 285.0 via email in 1~3 business day valid,,2024-1-1
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials 285.0 via email in 1~3 business day valid,,2024-1-1
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity 450.0 via email in 1 business day valid,,2018-7-1
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation 435.0 via email in 1 business day valid,,2023-5-1
GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products 140.0 via email in 1~3 business day superseded,2024-1-1,2018-7-1
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products 225.0 via email in 1~3 business day valid,,2024-1-1
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials 750.0 via email in 1~5 business day valid,,2024-1-1
YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy 690.0 via email in 1~5 business day valid,,2010-1-1
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management 375.0 via email in 1 business day valid,,2021-4-1
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling 255.0 via email in 1 business day valid,,2021-4-1
YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives―Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes 250.0 via email in 1~3 business day valid,,2016-1-1
YY/T 1465.7-2021 Immunogenic evaluation method of medical devices—Part 7:Liquid phase multiplex protein quantification technique by flow cytometry 120.0 via email in 1~3 business day valid,,2022-4-1
YY/T 1754.2-2020 Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats 180.0 via email in 1 business day valid,,2021-9-1
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GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process 
  Issued on: 2022-4-15   Price(USD): 585.0
GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization 
  Issued on: 2017-12-29   Price(USD): 800.0
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials 
  Issued on: 2017-12-29   Price(USD): 140.0
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials 
  Issued on: 2023-11-27   Price(USD): 315.0
GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices 
  Issued on: 2017-12-29   Price(USD): 140.0
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys 
  Issued on: 2022-12-30   Price(USD): 255.0
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables  
  Issued on: 2021-11-26   Price(USD): 255.0
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process 
  Issued on: 2022-12-30   Price(USD): 285.0
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials 
  Issued on: 2022-12-30   Price(USD): 285.0
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity 
  Issued on: 2017-12-29   Price(USD): 450.0
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation 
  Issued on: 2022-4-15   Price(USD): 435.0
GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products 
  Issued on: 2017-12-29   Price(USD): 140.0
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products 
  Issued on: 2022-12-30   Price(USD): 225.0
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials 
  Issued on: 2022-12-30   Price(USD): 750.0
YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy 
  Issued on: 2008-10-17   Price(USD): 690.0
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management 
  Issued on: 2020-03-31   Price(USD): 375.0
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling 
  Issued on: 2020-03-31   Price(USD): 255.0
YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives―Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes 
  Issued on: 2015-03-02   Price(USD): 250.0
YY/T 1465.7-2021 Immunogenic evaluation method of medical devices—Part 7:Liquid phase multiplex protein quantification technique by flow cytometry 
  Issued on: 2021-03-09   Price(USD): 120.0
YY/T 1754.2-2020 Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats 
  Issued on: 2020-09-27   Price(USD): 180.0
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