2025-12-19 216.73.216.41
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Code of China
Chinese National Standard List: Medical apparatus and devices in general

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
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
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
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
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
T/SZZX 016-2023 Expansion and threaded low pressure fittings for medical devices 
  Issued on: 2023-12-07   Translation Price(USD):
T/SZZX 014-2023 Probes for in-vitro diagnostic 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
T/ZGKSL 012-2023 Quality requirements for collagen products 
  Issued on: 2023-11-02   Translation Price(USD):
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
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes  
  Issued on: 2022-10-14   Translation Price(USD): 630.0
GB/T 42062-2022 Medical devices—Application of risk management to medical devices 
  Issued on: 2022-10-14   Translation Price(USD): 585.0
YY/T 1842.6-2022 Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 6:Neural applications 
  Issued on: 2022-08-17   Translation Price(USD): 160.0
YY/T 1851-2022 Medical pure tantalum powder for additive manufacturing 
  Issued on: 2022-08-17   Translation Price(USD): 195.0
YY/T 1852-2022 Medical devices for human assisted reproductive technology—Determination of ammonium in human assisted reproductive media 
  Issued on: 2022-08-17   Translation Price(USD): 165.0
GB/T 42818.1-2023 Cognitive accessibility —Part 1:General guidelines 
  Issued on: 2023-08-06   Translation Price(USD): 345.0
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