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Code of China
Chinese National Standard List: Medical apparatus and devices in general

GB/T 46942.1-2025 Single-molecule gene sequencing—Part 1:Terminology 
  Issued on: 2025-12-31   Translation Price(USD): 315.0
GB/T 46943-2025 Clinical laboratory testing and in vitro diagnostic test systems—General requirements for metagenomic next-generation sequencing validation 
  Issued on: 2025-12-31   Translation Price(USD): 315.0
GB/T 46660-2025 General technical requirements for whole genome sequencing of SARS-CoV-2 
  Issued on: 2025-10-31   Translation Price(USD): 210.0
GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents 
  Issued on: 2025-8-29   Translation Price(USD): 750.0
YY/T 1960-2025 Medical devices - Information to be supplied by the manufacturer 
  Issued on: 2025-06-18   Translation Price(USD): 630.0
GB/T 42818.2-2026 Cognitive accessibility—Part 2: Reporting 
  Issued on: 2026-01-28   Translation Price(USD): 570.0
YY 9706.278-2023 Medical electrical equipment--Part 2-78 : Particular requirements forbasic safety and essential performance of medical robots for rehabilitation,assessment, compensation or alleviation 
  Issued on: 2023-03-14   Translation Price(USD): 900.0
GB/T 44585.1-2024 Application of risk management for medical device connecting IT-network—Part 1：Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software 
  Issued on: 2024-09-29   Translation Price(USD): 645.0
T/CSBM 0059-2025 Testing method for antibacterial adhesion properties of coating 
  Issued on: 2025-09-16   Translation Price(USD):
T/CSBM 0058-2025 Test method for evaluation of the biodegradation and collagen regeneration of biodegradable particulate facial soft tissue fillers 
  Issued on: 2025-09-16   Translation Price(USD):
T/CSBM 0057-2025 Material characterization method for facial soft tissue implants containing degradable synthetic polymer microspheres or particles 
  Issued on: 2025-09-16   Translation Price(USD):
DB32/T 5325-2025 Technical guidelines for electronic records in medical device production and inspection 
  Issued on: 2025-12-30   Translation Price(USD):
DB32/T 5326-2025 Specification for identification design and application of medical device traceability system 
  Issued on: 2025-12-30   Translation Price(USD):
YY/T 1950-2024 Tissue engineering medical device products - Generic requirement for bio-derived peripheral nerve repair implant 
  Issued on: 2024-09-29   Translation Price(USD): 300.0
YY/T 1940-2024 Medical nickel titanium powders for additive manufacturing 
  Issued on: 2024-09-29   Translation Price(USD): 120.0
YY/T 1833.5-2024 Artificial intelligence medical device - Quality requirements and evaluation - Part 5 : Pre-trained models 
  Issued on: 2024-09-29   Translation Price(USD): 375.0
YY/T 0870.8-2024 Test for genotoxicity of medical devices - Part8 : Unscheduled DNA synthesis test with mammalianlivercellsinvivo 
  Issued on: 2024-07-08   Translation Price(USD): 200.0
MZ/T 238-2025 Monitoring and positioning systems-Millimeter wave radar monitoring alarm 
  Issued on: 2025-02-28   Translation Price(USD):
GB/T 44827-2024 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma 
  Issued on: 2024-10-26   Translation Price(USD): 315.0
DB12/T 3045-2025 Quality and technical requirements for medical laboratories 
  Issued on: 2025-03-24   Translation Price(USD):
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