China National Standards

China Medical Device GB Standards List


GB standards are the China national standards; Prefix code GB are Mandatory standards, GB/T are Recommended standards; All products or service must be compliance with GB standards; If you want to export products or services to huge Chinese market, need ensure they are meet the requirements of GB china national standards;  We provide Chinese GB standards and English version GB standards  Lookup, Translate, Download, Imported Commodity GB standards Testing and Compliance review services.
  •  China "Medical Device" GB Standards List:
  • Standard  Code Standard Title Standard Class Order
  • YY/T 0931-2014/XG1-2020
  • Medical endoscopes—Endotherapy device—Loop ligature Medical Device
    China YY-Medicine & Medical Device Industry Standards
  • 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 0202-1995
  • (Medical X-ray tomography device) 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 0292.2-1997
  • Protective devices against diagnostic medical X-radiation. Part 2: Protective glass plates Medical Device
    China Medicine & Medical Device Standards
  • YY 0292.1-1997
  • Protective devices against diagnostic medical X-radiation. Part 1: Determination of attenuation properties of materials 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 0590.1-2005
  • Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency 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 0318-2000
  • Protective device against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads 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 0202-2004
  • Medical diagnostic X-ray device for tomography Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0128-2004
  • Protective devices against diagnostic medical X-radiation. Device and tool Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0606.10-2008
  • Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage 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 0568-2005
  • Medical electrical devices Part 2: Requirements of safety use and special purpose use for head lamps for operational use and for diagnose 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 0600.1-2007
  • Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support 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 0202-2009
  • Specifications for medical diagnostic X-ray device for tomography 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 0590.2-2010
  • Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-2:Determination of the detective quantum efficiency. Detectors used in mammography 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 0590.3-2011
  • Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-3:Determination of the detective quantum efficiency. Detectors used in dynamic imaging Medical Device
    China Medicine & Medical Device Standards
  • YY 0847-2011
  • Medical endoscopes - Endotherapy device - Stone retrieval forceps 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 0944-2014
  • Medical endoscopes. Endotherapy device. Separating forceps Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0943-2014
  • Medical endoscopes. Endotherapy device. Needle forceps Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0941-2014
  • Medical endoscopes. Endotherapy device. Punch forceps Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0940-2014
  • Medical endoscopes-Endotherapy device. Grasping forceps Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0931-2014
  • Medical endoscopes. Endotherapy device. Loop ligature Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0930-2014
  • Medical endoscopes. Endotherapy device. Cytology brush 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
  • YY/T 1297-2015
  • Medical endoscope. Endotherapy device. Curette Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1295-2015
  • Biological evaluation of Medical Devices. Nanomaterial: Endotoxin test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1292.2-2015
  • Test for reproductive and developmental toxicity of Medical Devices. Part 2:Prenatal developmental toxicity test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1292.1-2015
  • Test for reproductive and developmental toxicity of Medical Devices. Part 1:Screening test Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1267-2015
  • Evaluation of materials of Medical Device subject to ethylene oxide sterilization Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1266-2015
  • Evaluation of materials of Medical Device subject to hydrogen peroxide sterilization Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1265-2015
  • Evaluation of materials of Medical Device subject to moist heat sterilization Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1264-2015
  • Evaluation of materials of Medical Device subject to ozone sterilization Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1263-2015
  • Evaluation of materials of Medical Device subject to dry heat sterilization Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0995-2015
  • Medical Devices for human assisted reproductive technology. Terminology and definitions Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1474-2016
  • (Medical Device Usability engineering applications for medical devices) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1465.2-2016
  • (Evaluation of immunological methods of Medical Devices - Part 2 serum immunoglobulins and complement components by ELISA) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1465.1-2016
  • (Evaluation of immunological methods of Medical Devices - Part 1 in vitro T lymphocyte transformation test) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1464-2016
  • (Development of Medical Devices - Low temperature steam sterilization formaldehyde sterilization process, validation and routine control) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1463-2016
  • (Medical Device sterilization and microbial challenge to confirm the selection of site contamination Guide) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1454-2016
  • (Self-vitro diagnostic Medical Devices for detecting the basic requirements) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1441-2016
  • (Performance evaluation of in vitro diagnostic Medical Devices General requirements) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1437-2016
  • (Medical Devices YY / T 0316 Application Guide) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1434-2016
  • (Human Assisted Reproductive Technology in vitro mouse embryo in vitro testing of Medical Devices) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1433-2016
  • (Medical Devices flexible packaging material hot seal strength (hot tack strength) Test Method) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1432-2016
  • (Test methods for sealing parameters flexible packaging materials for Medical Devices is determined by measuring the heat-sealing strength of the sample) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1406.1-2016
  • (Medical Device software - Part 1: YY / T0316 used in medical equipment Software Guide) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1402-2016
  • (Medical Devices steam sterilization process challenge device applicability of test methods) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1292.3-2016
  • (Reproductive and developmental toxicity of Medical Devices - Part 3: generation reproductive toxicity study) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 1276-2016
  • (Development of Medical Devices dry heat sterilization process, validation and routine control) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0972-2016
  • (Active implantable Medical Devices implanted pacemaker device with a four-pole connector system size and test requirements) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0869.2-2016
  • (Medical Device adverse event classification coding structure Part 2: Evaluation of coding) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0869.1-2016
  • (Medical Device adverse event classification coding structure - Part 1: Event type codes) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0467-2016
  • (Medical equipment to protect the safety and performance of Medical Devices accepted the basic principles of standards Selection Guide) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0466.1-2016
  • (Symbols - Part 1 Medical Devices for medical device labels, labeling and information: General requirements) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0316-2016
  • (Medical Device Risk Management for Medical Device Applications) Medical Device
    China Medicine & Medical Device Standards
  • YY/T 0127.18-2016
  • (Oral Biological evaluation of Medical Devices - Part 18: dentin barrier Cytotoxicity test) Medical Device
    China Medicine & Medical Device Standards
  • YY 0989.6-2016
  • (Requirements for the treatment of tachyarrhythmia of active implantable Medical Devices (including implantable defibrillators): The surgical implant of active implantable medical devices - Part 6) Medical Device
    China Medicine & Medical Device Standards
  • SN/T 3062.4-2011
  • Packaging materials for terminally sterilized Medical Devices for import. Part 4: Requirements for materials and sterile barrier systems of importing medical device sterilization packaging Medical Device
    China Import Export Inspection Standards
  • SN/T 3062.3-2011
  • Packaging materials for terminally sterilized Medical Devices for import. Part 3: Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods Medical Device
    China Import Export Inspection Standards
  • SN/T 3062.2-2011
  • Packaging materials for terminally sterilized Medical Devices for import. Part 2: Paper bags. Requirements and test methods Medical Device
    China Import Export Inspection Standards
  • SN/T 3062.1-2011
  • Packing materials for terminally sterilized Medical Devices for import. Part 1: Validation requirements for forming,sealing and assembly processes Medical Device
    China Import Export Inspection Standards
  • SN/T 3061-2011
  • Rules of the inspection of packaging for import terminally sterilized Medical Devices Medical Device
    China Import Export Inspection Standards
  • YY/T 0931-2014
  • Medical endoscopes. Endotherapy device. Loop ligature Medical Device
    China YY-Medicine & Medical Device Industry Standards
  • GB/T 29791.5-2013
  • In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting Medical Device
    China National Standards
  • GB/T 29791.4-2013
  • In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting Medical Device
    China National Standards
  • GB/T 29791.3-2013
  • In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use Medical Device
    China National Standards
  • GB/T 29791.2-2013
  • In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use Medical Device
    China National Standards
  • GB/T 29791.1-2013
  • In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements Medical Device
    China National Standards
  • GB/T 21415-2008
  • In vitro diagnostic Medical Devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials Medical Device
    China National Standards
  • GB/T 19974-2005
  • Sterilization of health care products -- General requirement for characterization of a sterilizing agent and the development ,validation and routine control of a sterilization process for Medical Devices Medical Device
    China National Standards
  • GB/T 19973.2-2005
  • Sterilization of Medical Devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process Medical Device
    China National Standards
  • GB/T 19973.1-2015
  • Sterilization of Medical Devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products Medical Device
    China National Standards
  • GB/T 19973.1-2005
  • Sterilization of Medical Devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products Medical Device
    China National Standards
  • GB/T 19703-2005
  • In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Description of reference materials Medical Device
    China National Standards
  • GB/T 19702-2005
  • In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures Medical Device
    China National Standards
  • GB/T 19633-2005
  • Packaging for terminally sterilized Medical Devices Medical Device
    China National Standards
  • GB/T 19633.2-2015
  • Packaging for terminally sterilized Medical Devices—Part 2: Validation requirements for forming, sealing and assembly processes Medical Device
    China National Standards
  • GB/T 19633.1-2015
  • Packaging for terminally sterilized Medical Devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Medical Device
    China National Standards
  • GB/T 18457-2015
  • Stainless steel needle tubing for the manufacture of Medical Devices Medical Device
    China National Standards
  • GB/T 17006.5-2000
  • Evaluation and routine testing in medical imaging departments--Part 2-5:Constancytests--Image display devices Medical Device
    China National Standards
  • GB/T 16886.9-2001
  • Biological evaluation of Medical Devices--Part 9:Framework for identification and quantification of potential degradation product Medical Device
    China National Standards
  • GB/T 16886.7-2015
  • Biological evaluation of Medical Devices—Part 7: Ethylene oxide sterilization residuals Medical Device
    China National Standards
  • GB/T 16886.7-2001
  • Biological evaluation of Medical Devices--Part 7:Ethylene oxide sterilization residuals Medical Device
    China National Standards
  • GB/T 16886.6-2015
  • Biological evaluation of Medical Devices—Part 6: Tests for local effects after implantation Medical Device
    China National Standards
  • GB/T 16886.6-1997
  • Biological evaluation of Medical Devices--Part 6:Tests for local effects after implantation Medical Device
    China National Standards
  • GB/T 16886.5-2003
  • Biological evaluation ofMedical Devices--Part 5: Test for in vitro cytotoxicity Medical Device
    China National Standards
  • GB/T 16886.4-2003
  • Biological evaluation of Medical Devices--Part 4:Selection of tests for interactions with blood Medical Device
    China National Standards
  • GB/T 16886.3-2008
  • Biological evaluation of Medical Devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity Medical Device
    China National Standards
  • GB/T 16886.2-2011
  • Biological evaluation of Medical Devices - Part 2: Animal welfare requirements Medical Device
    China National Standards
  • GB/T 16886.20-2015
  • Biological evaluation of Medical Devices—Part 20: Principles and methods for immunotoxicology testing of medical devices Medical Device
    China National Standards
  • GB/T 16886.19-2011
  • Biological evaluation of Medical Devices - Part 19: Physico-chemical,morphological and topographical characterization of materials Medical Device
    China National Standards
  • GB/T 16886.18-2011
  • Biological evaluation of Medical Devices - Part 18: Chemical characterization of materials Medical Device
    China National Standards
  • GB/T 16886.17-2005
  • Biological evaluation of Medical Devices -- Part 17: Establishment of allowable limits for leachable substances Medical Device
    China National Standards
  • GB/T 16886.16-2013
  • Biological evaluation of Medical Devices―Part 16: Toxicokinetic study design for degradation products and leachables Medical Device
    China National Standards
  • GB/T 16886.15-2003
  • Biological evaluation of Medical Devices--Part 15:Identification and quantification of degradation products from metals and alloys Medical Device
    China National Standards
  • GB/T 16886.14-2003
  • Biological evaluation of Medical Devices--Part 14:Identification and quantification of degradation products from ceramics Medical Device
    China National Standards
  • GB/T 16886.13-2001
  • Biological evaluation of Medical Devices--Part 13:Identification and quantification of degradation products from polymeric medical devices Medical Device
    China National Standards
  • GB/T 16886.12-2005
  • Biological evaluation of Medical Devices-Part 12:Sample preparation and reference materials Medical Device
    China National Standards
  • GB/T 16886.1-2011
  • Biological evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process Medical Device
    China National Standards
  • GB/T 16886.11-2011
  • Biological evaluation of Medical Devices - Part 11: Tests for systemic toxicity Medical Device
    China National Standards
  • GB/T 16886.10-2005
  • Biological evaluation of Medical Devices-Part 10:Tests for irritation and delayed-type hypersensitivity Medical Device
    China National Standards
  • GB 9706.24-2005
  • Medical electrical equipment-Part2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices Medical Device
    China National Standards
  • GB 24627-2009
  • Standard specification for wrought nickel-titanium shape memory alloys for Medical Devices and surgical implants Medical Device
    China National Standards
  • GB 19212.16-2005
  • Safety of power transformers ,power supply units and similar devices -- Part 16: Particular requirements for isolating transformers for the supply of medical locations Medical Device
    China National Standards
  • GB 18457-2001
  • Stainless steel needle tubing for manufactureof Medical Devices Medical Device
    China National Standards
  • GB 18280.1-2015
  • Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for Medical Devices Medical Device
    China National Standards
  • GB 18279-2000
  • Medical Devices--Validation androutine control of ethylene oxide sterilization Medical Device
    China National Standards
  • GB 18279.1-2015
  • Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for Medical Devices Medical Device
    China National Standards
  • GB 18278.1-2015
  • Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for Medical Devices Medical Device
    China National Standards
  • GB 16174.2-2015
  • Implants for surgery—Active implantable Medical Devices—Part 2: Cardiac pacemakers Medical Device
    China National Standards
  • GB 16174.1-2015
  • Implants for surgery—Active implantable Medical Devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Medical Device
    China National Standards

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