2025-12-14 216.73.216.3
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Code of China
Chinese National Standard List: Medical apparatus and devices in general

GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems 
  Issued on: 2008-12-15   Translation Price(USD): 140.0
YY 91057-1999 General specifications for medical foot switch 
  Issued on: 1987-12-28   Translation Price(USD): 40.0
GB/T 29888-2013 General requirements of DNA array-based mycobacteria identification 
  Issued on: 2013-11-12   Translation Price(USD): 120.0
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 
  Issued on: 2001-9-24   Translation Price(USD): 160.0
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 
  Issued on: 2001-9-24   Translation Price(USD): 130.0
GB 7955-1987 Test method of leakage between barrel and plunger of medical glass syringes 
  Issued on:   Translation Price(USD): 180.0
YY/T 0149-1993 Medical instruments of stainless steel -- Test methods of corrosion resistance 
  Issued on:   Translation Price(USD): 60.0
YY/T 1292.2-2015 Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity test 
  Issued on: 2015-03-02   Translation Price(USD): 225.0
GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity 
  Issued on: 2008-1-22   Translation Price(USD): 130.0
YY 0505-2012 Medical electrical equipment－Part 1-2:General requirements for safety－Collateral stanards：Electromagnetic compatibility－Requirements and tests 
  Issued on: 2012-12-17   Translation Price(USD): 180.0
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 
  Issued on: 2016-01-26   Translation Price(USD): 220.0
GB/T 19633-2005 Packaging for terminally sterilized medical devices 
  Issued on: 2005-1-24   Translation Price(USD): 250.0
YY/T 0993-2015 Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay) 
  Issued on: 2015-03-02   Translation Price(USD): 180.0
GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity 
  Issued on: 1997-06-26   Translation Price(USD): 165.0
GB/T 29790-2013 Point-of-care testing(POCT)— Requirements for quality and competence 
  Issued on: 2013-10-10   Translation Price(USD): 180.0
YY/T 1434-2016 Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assay 
  Issued on: 2016-01-26   Translation Price(USD): 160.0
YY/T 1427-2016 Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices 
  Issued on: 2016-01-26   Translation Price(USD): 170.0
GB/T 17827-1999 Guidelines for radiotherapy treatment rooms design 
  Issued on: 1999-8-11   Translation Price(USD): 150.0
YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process 
  Issued on: 2017-07-17   Translation Price(USD): 140.0
YY/T 0287-2017 Medical devices-Quality management systems- Requirements for regulatory purposes  
  Issued on: 2017-01-19   Translation Price(USD): 140.0
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