2025-12-13 216.73.216.3
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Code of China
Chinese National Standard List: Medical apparatus and devices in general

YY/T 1591-2017 Human epidermal growth factor receptor(EGFR) mutation detection kit 
  Issued on: 2017-12-05   Translation Price(USD): 160.0
YY/T 1597-2017 Neonatal phenylalanine testing kit 
  Issued on: 2017-12-05   Translation Price(USD): 160.0
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials 
  Issued on: 2017-12-29   Translation Price(USD): 140.0
GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization 
  Issued on: 2017-12-29   Translation Price(USD): 800.0
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   Translation Price(USD): 140.0
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity 
  Issued on: 2017-12-29   Translation Price(USD): 450.0
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   Translation Price(USD): 140.0
YY/T 1555.1-2017 Particular requirement of silicone gel filled breast implant-Performance requirement of silicone gel filler-Part 1:Limitation requirement of volatile substances 
  Issued on: 2017-03-28   Translation Price(USD): 100.0
YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test 
  Issued on: 2017-03-28   Translation Price(USD): 260.0
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 1057-2016 Genral specifications for medical foot switch 
  Issued on: 2016-01-26   Translation Price(USD): 60.0
GB/T 33805-2017 Technical requirement of laser confocal biochip scanner 
  Issued on: 2017-05-31   Translation Price(USD): 160.0
GB/T 33752-2017 Aldehyde slide for microarrays 
  Issued on: 2017-05-12   Translation Price(USD): 110.0
GB/T 33806-2017 Technical requirement of area fluorescent imaging microarray scanner 
  Issued on: 2017-05-31   Translation Price(USD): 160.0
GB 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer 
  Issued on: 2015-12-10   Translation Price(USD): 140.0
YY/T 1500-2016 Pyrogen test for medical devices―Monocyte-activation test―Human whole blood ELISA method 
  Issued on: 2016-07-29   Translation Price(USD): 160.0
YY/T 1465.5-2016 Immunogenic evaluation method of medical devices- Part 5:Determination of a-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody 
  Issued on: 2016-07-29   Translation Price(USD): 190.0
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
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