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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, Purchase services.
  •  China "Medical Device" GB Standards List:
    • Standard  Code GB Standard Title Standard Class Order
    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 0869.2-2016 (Medical Device adverse event classification coding structure Part 2: Evaluation of coding)

    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 1276-2016 (Development of Medical Devices dry heat sterilization process, validation and routine control)

    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 1402-2016 (Medical Devices steam sterilization process challenge device applicability of test methods)

    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 0869.1-2016 (Medical Device adverse event classification coding structure - Part 1: Event type codes)

    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
    YY/T 1437-2016 (Medical Devices YY / T 0316 Application Guide)

    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 1454-2016 (Self-vitro diagnostic Medical Devices for detecting the basic requirements)

    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 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 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 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 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
    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 1474-2016 (Medical Device Usability engineering applications for medical devices)

    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 1265-2015 Evaluation of materials of Medical Device subject to moist heat 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 1267-2015 Evaluation of materials of Medical Device subject to ethylene oxide sterilization

    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 1297-2015 Medical endoscope. Endotherapy device. Curette

    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 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 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 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 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 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
    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
    手术植入物 有源植入式医疗器械 第1部分：安全、标记和制造商所提供信息的通用要求

    Medical Device-China National GB Standards
    GB/T 19633.2-2015 Packaging for terminally sterilized Medical Devices—Part 2: Validation requirements for forming, sealing and assembly processes
    最终灭菌医疗器械包装 第2部分：成形、密封和装配过程的确认的要求

    Medical Device-China National GB Standards
    YY/T 1295-2015 Biological evaluation of Medical Devices. Nanomaterial: Endotoxin test

    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
    GB/T 16886.7-2015 Biological evaluation of Medical Devices—Part 7: Ethylene oxide sterilization residuals
    医疗器械生物学评价 第7部分：环氧乙烷灭菌残留量

    Medical Device-China National GB Standards
    GB/T 16886.6-2015 Biological evaluation of Medical Devices—Part 6: Tests for local effects after implantation
    医疗器械生物学评价 第6部分：植入后局部反应试验

    Medical Device-China National GB Standards
    GB/T 19633.1-2015 Packaging for terminally sterilized Medical Devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
    最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求

    Medical Device-China National GB Standards
    GB/T 16886.20-2015 Biological evaluation of Medical Devices—Part 20: Principles and methods for immunotoxicology testing of medical devices
    医疗器械生物学评价 第20部分：医疗器械免疫毒理学试验原则和方法

    Medical Device-China National GB 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
    医疗保健产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

    Medical Device-China National GB 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
    医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求

    Medical Device-China National GB 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
    医疗保健产品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

    Medical Device-China National GB Standards
    GB/T 19973.1-2015 Sterilization of Medical Devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products
    医疗器械的灭菌 微生物学方法 第1部分：产品上微生物总数的测定

    Medical Device-China National GB Standards
    GB 16174.2-2015 Implants for surgery—Active implantable Medical Devices—Part 2: Cardiac pacemakers
    手术植入物 有源植入式医疗器械 第2部分：心脏起搏器

    Medical Device-China National GB 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 0995-2015 Medical Devices for human assisted reproductive technology. Terminology and definitions

    Medical Device-China Medicine & Medical Device Standards
    GB/T 18457-2015 Stainless steel needle tubing for the manufacture of Medical Devices
    制造医疗器械用不锈钢针管

    Medical Device-China National GB 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 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 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 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 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 0681.11-2014 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 0940-2014 Medical endoscopes-Endotherapy device. Grasping forceps

    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 0930-2014 Medical endoscopes. Endotherapy device. Cytology brush

    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 0870.1-2013 Test for genotoxicity of Medical Devices. Part 1: Bacterial reverse mutation test

    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 0870.3-2013 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 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
    GB/T 29791.5-2013 In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting
    体外诊断医疗器械 制造商提供的信息（标示） 第5部分：自测用体外诊断仪器

    Medical Device-China National 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
    GB/T 29791.4-2013 In vitro diagnostic Medical Devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting
    体外诊断医疗器械 制造商提供的信息（标示） 第4部分：自测用体外诊断试剂

    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
    体外诊断医疗器械 制造商提供的信息（标示） 第3部分：专业用体外诊断仪器

    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
    体外诊断医疗器械 制造商提供的信息（标示） 第2部分：专业用体外诊断试剂

    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
    体外诊断医疗器械 制造商提供的信息（标示） 第1部分：术语、定义和通用要求

    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
    医疗器械生物学评价 第16部分：降解产物与可沥滤物毒代动力学研究设计

    Medical Device-China National GB 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
    进口医疗器械灭菌包装 第4部分：材料和预成型无菌屏障系统要求

    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
    进口医疗器械灭菌包装 第1部分：成形、密封和装配过程的确认要求

    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
    进口医疗器械灭菌包装 第2部分：纸袋-要求和试验方法

    Medical Device-China Import Export Inspection Standards
    GB/T 16886.18-2011 Biological evaluation of Medical Devices - Part 18: Chemical characterization of materials
    医疗器械生物学评价 第18部分：材料化学表征

    Medical Device-China National GB Standards
    GB/T 16886.19-2011 Biological evaluation of Medical Devices - Part 19: Physico-chemical,morphological and topographical characterization of materials
    医疗器械生物学评价 第19部分：材料物理化学、形态学和表面特性表征

    Medical Device-China National GB Standards
    GB/T 16886.2-2011 Biological evaluation of Medical Devices - Part 2: Animal welfare requirements
    医疗器械生物学评价 第2部分：动物福利要求

    Medical Device-China National GB Standards
    GB/T 16886.1-2011 Biological evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process
    医疗器械生物学评价 第1部分：风险管理过程中的评价与试验

    Medical Device-China National GB Standards
    SN/T 3061-2011 Rules of the inspection of packaging for import terminally sterilized Medical Devices
    进口医疗器械灭菌包装检验操作规程

    Medical Device-China Import Export Inspection 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
    GB/T 16886.11-2011 Biological evaluation of Medical Devices - Part 11: Tests for systemic toxicity
    医疗器械生物学评价 第11部分：全身毒性试验

    Medical Device-China National GB 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
    进口医疗器械灭菌包装 第3部分：透气材料与塑料膜组成的可密封组合袋和卷材要求和试验方法

    Medical Device-China Import Export Inspection 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 0681.8-2011 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 0681.10-2011 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 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

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