China Medical Device GB Standards Search System

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	GB Standard Title	Standard Class
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 16886.5-2017	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 16886.10-2017	Biological evaluation of Medical Devices—Part 10: Tests for irritation and skin sensitization	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
GB/T 16886.12-2017	Biological evaluation of Medical Devices—Part 12:Sample preparation and reference materials	Medical Device China National 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 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 1402-2016	(Medical Devices steam sterilization process challenge device applicability of test methods)	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 0316-2016	(Medical Device Risk Management for Medical Device Applications)	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
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 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 1441-2016	(Performance evaluation of in vitro diagnostic Medical Devices General requirements)	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 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 0127.18-2016	(Oral Biological evaluation of Medical Devices - Part 18: dentin barrier Cytotoxicity test)	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 0869.1-2016	(Medical Device adverse event classification coding structure - Part 1: Event type codes)	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 1437-2016	(Medical Devices YY / T 0316 Application Guide)	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 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 1454-2016	(Self-vitro diagnostic Medical Devices for detecting the basic requirements)	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 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
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/T 18457-2015	Stainless steel needle tubing for the manufacture of Medical Devices	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 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/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 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/T 16886.6-2015	Biological evaluation of Medical Devices—Part 6: Tests for local effects after implantation	Medical Device China National Standards
GB/T 16886.7-2015	Biological evaluation of Medical Devices—Part 7: Ethylene oxide sterilization residuals	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 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
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 16174.2-2015	Implants for surgery—Active implantable Medical Devices—Part 2: Cardiac pacemakers	Medical Device China National Standards
YY/T 1264-2015	Evaluation of materials of Medical Device subject to ozone sterilization	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 1295-2015	Biological evaluation of Medical Devices. Nanomaterial: Endotoxin 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 0995-2015	Medical Devices for human assisted reproductive technology. Terminology and definitions	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 1297-2015	Medical endoscope. Endotherapy device. Curette	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 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 1265-2015	Evaluation of materials of Medical Device subject to moist heat sterilization	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 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 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 1267-2015	Evaluation of materials of Medical Device subject to ethylene oxide sterilization	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 0940-2014	Medical endoscopes-Endotherapy device. Grasping 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 0943-2014	Medical endoscopes. Endotherapy device. Needle forceps	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 0944-2014	Medical endoscopes. Endotherapy device. Separating 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 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 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 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 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 0926-2014	Quantitative analysis of DEHP in PVC Medical Devices	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 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 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 0870.4-2014	Test for genotoxicity of Medical Devices. Part 4:Mammalian bone marrow erythocyte micronucleus test	Medical Device China Medicine & Medical Device 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
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 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 0878.1-2013	Test for complement activation of Medical Devices. Part:Serum whole complement activation	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 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 0869-2013	Medical Devices. Coding structure for adverse event type and cause	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
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 29791.5-2013	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 29791.1-2013	In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements	Medical Device China National Standards
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 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 0847-2011	Medical endoscopes - Endotherapy device - Stone retrieval forceps	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 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 0681.6-2011	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 0681.8-2011	Test methods for sterile Medical Device package. Part 8: Coating/adhesive weight determination	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
GB/T 16886.11-2011	Biological evaluation of Medical Devices - Part 11: Tests for systemic toxicity	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 16886.2-2011	Biological evaluation of Medical Devices - Part 2: Animal welfare requirements	Medical Device China National 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

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