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Chinese National Standard List: Medical apparatus and devices in general

YY/T 1863-2023 Biological evaluation for nanomaterial medical devices--Testing andcharacterization methods for silver nanoparticles and ions released fromsilver nanoparticle containing dressing 
  Issued on: 2023-01-13   Translation Price(USD): 285.0
YY/T 1789.6-2023 In vitro diagnostic test systems―Performance evaluation method―Part 6:Precision, diagnostic sensitivity and specificity of qualitative reagents 
  Issued on: 2023-01-13   Translation Price(USD): 225.0
YY/T 0870.7-2023 Test for genotoxicity of medical devices-Part 7;In vivo mammalian alkaline comet assay 
  Issued on: 2023-01-13   Translation Price(USD): 160.0
YY/T 1842.7-2023 Medical devices―Connectors for reservoir delivery systems for healthcare applications―Part 7:Connectors for intravascular infusion 
  Issued on: 2023-01-13   Translation Price(USD): 435.0
YY/T 1473-2023 Guide for standardization for medical devices―Inclusion of safety aspects in the development of standards 
  Issued on: 2023-01-13   Translation Price(USD): 375.0
T/SZZX 017-2024 Medical electrical equipment―General technical specification for switching power supply 
  Issued on: 2024-01-09   Translation Price(USD):
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system 
  Issued on: 2022-12-30   Translation Price(USD): 900.0
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   Translation Price(USD): 285.0
YY/T 1789.4-2022 In vitro diagnostic test systems—Performance evaluation mcthod—Part 4 ; Linear interval and reportable interval 
  Issued on: 2022-07-01   Translation Price(USD): 555.0
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials 
  Issued on: 2022-12-30   Translation Price(USD): 750.0
YY/T 1789.3-2022 In vitro diagnestic test systems—Performance evaluation method一Part 3: Limit of detection and limit of quantitation 
  Issued on: 2022-07-01   Translation Price(USD): 555.0
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   Translation Price(USD): 285.0
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   Translation Price(USD): 225.0
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   Translation Price(USD): 255.0
T/SZZX 014-2023 Probes for in-vitro diagnostic medical devices 
  Issued on: 2023-12-07   Translation Price(USD):
T/SZZX 016-2023 Expansion and threaded low pressure fittings for medical devices 
  Issued on: 2023-12-07   Translation Price(USD):
GB/T 14191.3-2023 Prosthetics and orthotics—Vocabulary—Part 3: Terms relating to orthoses  
  Issued on: 2023-05-23   Translation Price(USD): 220.0
GB/T 42062-2022 Medical devices—Application of risk management to medical devices 
  Issued on: 2022-10-14   Translation Price(USD): 585.0
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes  
  Issued on: 2022-10-14   Translation Price(USD): 630.0
YY/T 0688.1-2023 Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 1:Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic  
  Issued on: 2023-03-14   Translation Price(USD): 345.0
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