2026-3-26 216.73.216.28
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Code of China
Chinese National Standard List: Medical apparatus and devices in general

GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2: Animal welfare requirements 
  Issued on: 2026-01-28   Translation Price(USD): 375.0
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):
YY/T 1956-2025 Clinical investigation of in vitro diagnostic reagents—Terms and definitions  
  Issued on: 2025-02-26   Translation Price(USD): 210.0
YY/T 1955-2025 Tissue engineering medical device—Collagen—Terminology  
  Issued on: 2025-02-26   Translation Price(USD): 165.0
YY/T 1954-2025 Peptide mass fingerprinting analysis of recombinant collagen 
  Issued on: 2025-02-26   Translation Price(USD): 165.0
GB/T 45214-2025 Data quality evaluation method of human whole genome sequencing 
  Issued on: 2025-01-24   Translation Price(USD): 270.0
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):
GB/Z 157-2026 In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods 
  Issued on: 2026-1-28   Translation Price(USD): 600.0
DB14/T 3543-2025  
  Issued on: 2025-07-30   Translation Price(USD):
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