2025-12-14 216.73.216.3
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Code of China
Chinese National Standard List: Medical apparatus and devices in general

YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes  
  Issued on: 2017-01-19   Translation 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   Translation Price(USD): 170.0
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing 
  Issued on: 2016-01-26   Translation Price(USD): 100.0
YY/T 1287.2-2016 Intracranial external drainage system—Part 2:Collecting sets for external drainage by lumbar puncture 
  Issued on: 2016-01-26   Translation Price(USD): 220.0
YY/T 1287.1-2016 Intracranial external drainage system—Part 1:Collecting sets for external drainage by intracranial puncture 
  Issued on: 2016-03-23   Translation Price(USD): 250.0
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 0616.1-2016 Medical gloves for single use―Part 1:Requirements and testing for biological evaluation 
  Issued on: 2016-01-26   Translation Price(USD): 140.0
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
GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices 
  Issued on: 2015-12-10   Translation Price(USD): 140.0
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 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices 
  Issued on: 2016-01-26   Translation Price(USD): 130.0
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/T 0869.1-2016 Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes 
  Issued on: 2016-01-26   Translation Price(USD): 250.0
YY/T 1474-2016 Medical devices－Application of risk management to medical devices 
  Issued on: 2016-01-26   Translation Price(USD): 1200.0
YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices 
  Issued on: 2016-01-26   Translation Price(USD): 320.0
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 1434-2016 Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assay 
  Issued on: 2016-01-26   Translation Price(USD): 160.0
YY/T 1427-2016 Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices 
  Issued on: 2016-01-26   Translation Price(USD): 170.0
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   Translation Price(USD): 250.0
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