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
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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