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China Medical Device GB Standards List


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  •  China "Medical Device" GB Standards List:
  • Standard  Code Standard Title Standard Class Order
  • GB/T 16886.3-2019
  • Biological evaluation of Medical Devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Medical Device
    China National Standards
  • GB/T 19974-2018
  • Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for Medical Devices Medical Device
    China National Standards
  • GB/T 19973.2-2018
  • Sterilization of Medical Devices—Microbiological methods—Part 2: Tests of sterility performed in the definition,validation and maintenance of a sterilization process Medical Device
    China National Standards
  • GB/T 16886.10-2017
  • Biological evaluation of Medical Devices—Part 10: Tests for irritation and skin sensitization Medical Device
    China National Standards
  • GB/T 16886.12-2017
  • Biological evaluation of Medical Devices—Part 12:Sample preparation and reference materials Medical Device
    China National Standards
  • GB/T 16886.5-2017
  • Biological evaluation of Medical Devices—Part 5: Tests for in vitro cytotoxicity Medical Device
    China National Standards
  • GB/T 16886.13-2017
  • Biological evaluation of Medical Devices—Part 13: Identification and quantification of degradation products from polymeric medical devices Medical Device
    China National Standards
  • GB/T 16886.9-2017
  • Biological evaluation of Medical Devices—Part 9: Framework for identification and quantification of potential degradation products Medical Device
    China National Standards
  • YY/T 0052-1991
  • (Change the way the Medical Device product design and design documents) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0051-1991
  • (The integrity of the Medical Device product design and its main design file) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0050-1991
  • (Medical Device product design and design principles File No.) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0049-1991
  • (Medical Device product design and design file formats) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0048-1991
  • (The basic requirements for Medical Devices work pattern) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0047-1991
  • (The term Medical Device product design and design documents) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0288-1996
  • Quality system. Medical Devices. Particular requirements for the application of GB/T 19002. ISO 9002 Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0287-1996
  • Quality system—Medical Devices—Particular requirements for the application of GB/T 19001—ISO 9001 Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0297-1997
  • Clinical investigation of Medical Devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 91051-1999
  • System table for standard of Medical Devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 91050-1999
  • Editorial method for design documents of Medical Device products Medical Device
    China Medicine & Medical Device Standards
  • YY 91055-1999
  • Paint coating for Medical Devices. Classification and specification Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0316-2000
  • Medical Devices. Risk management. Part 1: Application of risk analysis Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1000.2-2005
  • Development of Medical Devices industrial standards. Part 2: Guidance for work Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1000.1-2005
  • Development of Medical Devices industrial standards. Part 1: Stage division, code and procedure Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0639-2008
  • In Vitro Diagnostic Medical Devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0638-2008
  • In vitro diagnostic Medical Devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials Medical Device
    China Medicine & Medical Device Standards
  • YY 0033-2000
  • Good manufacture practice for sterile Medical Devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0268-2001
  • Dentistry--Preclinical evaluation of biocompatibility of Medical Devices used in dentistry--Part 1: Evaluation and test methods selection Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.11-2001
  • Dentistry--Preclinical evaluation of biocompatibility of Medical Devices used in dentistry--Part 2: Biological evaluation test method of dental materials--Pulp capping test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0468-2003
  • Nomenclature-Specification for a nomenclature system for Medical Devices for the purpose of regulatory data exchange Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0467-2003
  • Medical Devices. Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0316-2003
  • Medical Devices-Application of risk management to medical devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0287-2003
  • Medical Devices. Quality management systems. Requirements for regulatory purposes Medical Device
    China Medicine & Medical Device Standards
  • YY 0466-2003
  • Medical Devices-Symbols to be used with medical device labels, labelling and information to be supplied Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0316-2008
  • Medical Devices. Application of risk management to medical devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0268-2008
  • Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 1: Evaluation and test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.12-2008
  • Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Micronucleus test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0595-2006
  • Medical Devices. Quality management systems. Guidance on the application of YY/T0287-2003 Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0615.2-2007
  • Requirements for Medical Devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0615.1-2007
  • Requirements for Medical Devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0690-2008
  • Clinical laboratory testing and in vitro Medical Devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0664-2008
  • Medical Device software. Software life cycle processes Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0771.3-2009
  • Medical Devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0771.2-2009
  • Medical Devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handling Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0771.1-2009
  • Medical Devices utilizing animal tissues and their derivatives. Part 1: Application of risk management Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0806-2010
  • Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other Medical Devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0802-2010
  • Sterilization of Medical Devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.9-2009
  • Packaging materials for terminally sterilized Medical Devices. Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.8-2009
  • Packaging materials for terminally sterilized Medical Devices. Part 8: Re-usable sterilization containers for team sterilizers. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.7-2009
  • Packaging materials for terminal sterilized Medical Devices. Part 7: Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.6-2009
  • Packaging materials for terminal sterilized Medical Devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.5-2009
  • Packaging materials for terminal sterilized Medical Devices. Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.4-2009
  • Packaging materials for terminal sterilized Medical Devices. Part 4: Paper bags. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.3-2009
  • Packaging materials for terminal sterilized Medical Devices. Part 3: Paper for use in the manufacture of paper bags (specified in YY/T 0698.4) and in the manufacture of pouches and reels (specified in YY/T 0698.5). Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.2-2009
  • Packaging materials for terminal sterilized Medical Devices. Part 2: Sterilization wrap. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.10-2009
  • Packaging materials for terminally sterilized Medical Devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.1-2009
  • Test methods for sterile Medical Device package. Part 1: Test guide for accelerated aging Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0506.6-2009
  • Surigical drapes, gowns and clean air suits, used as Medical Devices, for patients, clinical staff and equipment. Part 6: Test method to determine the resistance to wet bacterial penetration Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0466.1-2009
  • Medical Devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.9-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Cytotoxicity tests:Agar diffusion test and filter diffusion test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.4-2009
  • Biological evaluation of Medical Devices used in dentistry - Part 2: Test method - Bone implant test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.2-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute systemic toxicity:intravenous path Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.16-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. In Vitro mammalian chromosome aberration test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.15-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Subacute and subchronic systemic toxicity test:oral route Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.14-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute oral toxicity test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.13-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Tset method. Oral mucous membrane irritation test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.10-2009
  • Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.5-2010
  • Test methods for sterile Medical Device package. Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.4-2010
  • Test methods for sterile Medical Device package. Part 4: Detecting seal leaks in porous packages by dye penetration Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.3-2010
  • Test methods for sterile Medical Device package. Part 3: Internal pressurization failure resistance of unrestrained packages Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.2-2010
  • Test methods for sterile Medical Device package. Part 2: Seal strength of flexible battier materials Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0698.1-2011
  • Packaging materials for terminal sterilized Medical Devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.9-2011
  • Test methods for sterile Medical Device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.8-2011
  • Test methods for sterile Medical Device package. Part 8: Coating/adhesive weight determination Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.7-2011
  • Test methods for sterile Medical Device package. Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.6-2011
  • Test methods for sterile Medical Device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.10-2011
  • Test methods for sterile Medical Device package. Part 10: Test for microbial barrier ranking of porous package material Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0879.1-2013
  • Test for sensitization of Medical Devices. Part 1: Murine local lymph node assay(LINA):Radioisotope incorporation method Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0878.1-2013
  • Test for complement activation of Medical Devices. Part:Serum whole complement activation Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0870.3-2013
  • Test for genotoxicity of Medical Devices. Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0870.2-2013
  • Test for genotoxicity of Medical Devices. Part 2: In vitro mammalian chromosome aberration test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0870.1-2013
  • Test for genotoxicity of Medical Devices. Part 1: Bacterial reverse mutation test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0869-2013
  • Medical Devices. Coding structure for adverse event type and cause Medical Device
    China Medicine & Medical Device Standards
  • YY 0970-2013
  • Sterilization of single- use Medical Devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0993-2015
  • Biological evaluation of Medical Devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0879.2-2015
  • Test for hypersensitivity of Medical Devices. Part 2:Marine Local Lymph Node Assay (LLNA): BrdU-ELISA method Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0878.2-2015
  • Test for complement activation of Medical Devices. Part 2: Serum alternative pathway complement activation Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0771.4-2015
  • Medical Devices utilizing animal tissues and their derivatives. Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0468-2015
  • Medical Devices. Quality management. Medical device nomenclature data structure Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0466.2-2015
  • Medical Devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2: Symbol development, selection and validation Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0927-2014
  • Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC Medical Devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0926-2014
  • Quantitative analysis of DEHP in PVC Medical Devices Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0870.5-2014
  • Test for genotoxicity of Medical Devices. Part 5: Mammalian bone marrow chromosome aberration test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0870.4-2014
  • Test for genotoxicity of Medical Devices. Part 4:Mammalian bone marrow erythocyte micronucleus test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.13-2014
  • Test methods for sterile Medical Device package. Part 13: Slow rate penetration resistance of flexible barrier films and laminates Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.12-2014
  • Test methods for sterile Medical Device package. Part 12: Flex durability of flexible barrier films Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0681.11-2014
  • Test methods for sterile Medical Device package. Part 11: Determining integrity of seals for medical packaging by visual inspection Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.5-2014
  • Biological evaluation of Medical Devices used in dentistry. Part 5: Inhalation toxicity test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.3-2014
  • Biological evaluation of Medical Devices used in dentistry-Part 3: Endodontic usage test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.17-2014
  • Biological evaluation of Medical Devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.11-2014
  • Biological evaluation of Medical Devices used in dentistry. Part 11: Pulp capping test Medical Device
    China Medicine & Medical Device Standards

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