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Chinese National Standard List: Medical apparatus and devices in general

YY/T 1833.4-2023 Artificial intelligence medical device-Quality requirements and evaluation-Part 4:Traceability  
  Issued on: 2023-09-05   Translation Price(USD): 195.0
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products 
  Issued on: 2023-09-05   Translation Price(USD): 105.0
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration 
  Issued on: 2023-09-05   Translation Price(USD): 225.0
YY/T 1907-2023 Artificial intelligence medical device―Coronary CT image processing software―Algorithm performance test methods 
  Issued on: 2023-09-05   Translation Price(USD): 315.0
T/CQAP 2003-2024 Prepared media plate for clean environment microbial monitoring 
  Issued on: 2024-05-30   Translation Price(USD): 345.0
DB14/T 3007-2024  
  Issued on: 2024-05-29   Translation Price(USD):
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test 
  Issued on: 2023-06-20   Translation Price(USD): 195.0
YY/T 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties 
  Issued on: 2023-06-20   Translation Price(USD): 240.0
YY/T 1899-2023 Preparation and evaluation methods of histopathological samples after implantation of absorbable medical devices 
  Issued on: 2023-06-20   Translation Price(USD): 195.0
YY/T 1437-2023 Medical devices-Guidance on the application of GB/T 42062  
  Issued on: 2023-06-20   Translation Price(USD): 1125.0
GB/Z 43280-2023 Medical laboratories—Practical guidance for the estimation of measurement uncertainty 
  Issued on: 2023-11-27   Translation Price(USD): 975.0
GB/T 43279.1-2023 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 1: Isolated cellular RNA 
  Issued on: 2023-11-27   Translation Price(USD): 315.0
GB/T 43279.2-2023 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 2:Isolated genomic DNA 
  Issued on: 2023-11-27   Translation Price(USD): 255.0
GB/Z 43281-2023 Guidance for supervisors and operators of point-of-care testing(POCT) devices 
  Issued on: 2023-11-27   Translation Price(USD): 495.0
GB/T 43279.3-2023 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 3: Isolated circulating cell free DNA from plasma 
  Issued on: 2023-11-27   Translation Price(USD): 315.0
GB/T 43278-2023 Medical laboratories—Application of risk management to medical laboratories 
  Issued on: 2023-11-27   Translation Price(USD): 990.0
DB14/T 2996-2024  
  Issued on: 2024-02-08   Translation Price(USD):
YY/T 1789.5-2023 In vitro diagnostic test systems--Performance evaluation method一Part 5:Analytical specificity 
  Issued on: 2023-03-14   Translation Price(USD): 480.0
DB3710/T 225-2024  
  Issued on: 2024-02-23   Translation Price(USD):
YY/T 1915-2023 General requirments for laboratory testing of immunochromatographic kits 
  Issued on: 2023-09-05   Translation Price(USD): 150.0
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