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China Medical Device GB Standards English PDF List


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  •  China "Medical Device" GB Standards English PDF List:
  • Standard  Code Standard Title Standard Class Order
    GB/T 16886.23-2023 Biological evaluation of Medical Devices Part 23: Stimulation test
    医疗器械生物学评价 第23部分:刺激试验
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.12-2023 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
    医疗器械生物学评价 第12部分:样品制备与参照材料
    China National Standards
    Medical Device

    English PDF
    GB 18279-2023 Sterilization of healthcare products Ethylene oxide Requirements for the development, validation and routine control of Medical Device sterilization processes
    医疗保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、确认和常规控制要求
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.6-2022 Biological evaluation of Medical Devices Part 6: local response test after implantation
    医疗器械生物学评价 第6部分:植入后局部反应试验
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.4-2022 Biological evaluation of Medical Devices - Part 4: selection of interaction test with blood
    医疗器械生物学评价 第4部分:与血液相互作用试验选择
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.1-2022 Biological evaluation of Medical Devices Part 1: evaluation and testing in the process of risk management
    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
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.19-2022 Biological evaluation of Medical Devices - Part 19: Physicochemical, morphological and surface 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
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.18-2022 Biological evaluation of Medical Devices - Part 18: Chemical characterization of medical device materials in the risk management process
    医疗器械生物学评价 第18部分:风险管理过程中医疗器械材料的化学表征
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.15-2022 Biological Evaluation of Medical Devices-Part 15: Qualitative and Quantitative Degradation Products of Metals and Alloys
    医疗器械生物学评价 第15部分:金属与合金降解产物的定性与定量
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.9-2022 Biological evaluation of Medical Devices - Part 9: Qualitative and quantitative framework for potential degradation products
    医疗器械生物学评价 第9部分:潜在降解产物的定性和定量框架
    China National Standards
    Medical Device

    English PDF
    GB/Z 16886.22-2022 Biological Evaluation of Medical Devices Part 22: Guidelines for Nanomaterials
    医疗器械生物学评价 第22部分:纳米材料指南
    China National Standards
    Medical Device

    English PDF
    GB/Z 42217-2022 Medical Devices for the validation of medical device quality system software
    医疗器械 用于医疗器械质量体系软件的确认
    China National Standards
    Medical Device

    English PDF
    GB/T 42218-2022 Laboratory medicine - In vitro diagnostic Medical Devices - Manufacturer's confirmation of quality control procedures provided to users
    检验医学 体外诊断医疗器械 制造商对提供给用户的质量控制程序的确认
    China National Standards
    Medical Device

    English PDF
    GB/T 42062-2022 Medical Devices Application of Risk Management to Medical Devices
    医疗器械 风险管理对医疗器械的应用
    China National Standards
    Medical Device

    English PDF
    GB/T 42061-2022 Medical Device quality management system for regulatory requirements
    医疗器械 质量管理体系 用于法规的要求
    China National Standards
    Medical Device

    English PDF
    GB/T 19702-2021 In vitro diagnostic Medical Devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
    体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.16-2021 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
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.11-2021 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
    China National Standards
    Medical Device

    English PDF
    GB/T 19703-2020 In vitro diagnostic Medical Devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
    体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.3-2019 Biological evaluation of Medical Devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    医疗器械生物学评价 第3部分:遗传毒性、致癌性和生殖毒性试验
    China National Standards
    Medical Device

    English PDF
    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
    医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
    China National Standards
    Medical Device

    English PDF
    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
    医疗器械的灭菌 微生物学方法 第2部分:用于灭菌过程的定义、确认和维护的无菌试验
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.10-2017 Biological evaluation of Medical Devices—Part 10: Tests for irritation and skin sensitization
    医疗器械生物学评价 第10部分:刺激与皮肤致敏试验
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.12-2017 Biological evaluation of Medical Devices—Part 12:Sample preparation and reference materials
    医疗器械生物学评价 第12部分:样品制备与参照材料
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.5-2017 Biological evaluation of Medical Devices—Part 5: Tests for in vitro cytotoxicity
    医疗器械生物学评价 第5部分:体外细胞毒性试验
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.13-2017 Biological evaluation of Medical Devices—Part 13: Identification and quantification of degradation products from polymeric medical devices
    医疗器械生物学评价 第13部分:聚合物医疗器械降解产物的定性与定量
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.9-2017 Biological evaluation of Medical Devices—Part 9: Framework for identification and quantification of potential degradation products
    医疗器械生物学评价 第9部分:潜在降解产物的定性和定量框架
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    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
    China National Standards
    Medical Device

    English PDF
    GB 24627-2009 Standard specification for wrought nickel-titanium shape memory alloys for Medical Devices and surgical implants
    医疗器械和外科植入物用镍-钛形状记忆合金加工材
    China National Standards
    Medical Device

    English PDF
    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
    体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.3-2008 Biological evaluation of Medical Devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity
    医疗器械生物学评价 第3部分:遗传毒性、致癌性和生殖毒性试验
    China National Standards
    Medical Device

    English PDF
    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
    医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求
    China National Standards
    Medical Device

    English PDF
    GB/T 19973.2-2005 Sterilization of Medical Devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process
    医用器材的灭菌 微生物学方法 第二部分:确认灭菌过程的无菌试验
    China National Standards
    Medical Device

    English PDF
    GB/T 19973.1-2005 Sterilization of Medical Devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products
    医用器材的灭菌 微生物学方法 第一部分:产品上微生物总数的估计
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.17-2005 Biological evaluation of Medical Devices -- Part 17: Establishment of allowable limits for leachable substances
    医疗器械生物学评价 第17部分:可沥滤物允许限量的建立
    China National Standards
    Medical Device

    English PDF
    GB/T 19703-2005 In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Description of reference materials
    体外诊断医疗器械 生物源性样品中量的测量 参考物质的说明
    China National Standards
    Medical Device

    English PDF
    GB/T 19702-2005 In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures
    体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的说明
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.12-2005 Biological evaluation of Medical Devices-Part 12:Sample preparation and reference materials
    医疗器械生物学评价 第12部分:样品制备与参照样品
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.10-2005 Biological evaluation of Medical Devices-Part 10:Tests for irritation and delayed-type hypersensitivity
    医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验
    China National Standards
    Medical Device

    English PDF
    GB/T 19633-2005 Packaging for terminally sterilized Medical Devices
    最终灭菌医疗器械的包装
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.5-2003 Biological evaluation ofMedical Devices--Part 5: Test for in vitro cytotoxicity
    医疗器械生物学评价 第5部分: 体外细胞毒性试验
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.4-2003 Biological evaluation of Medical Devices--Part 4:Selection of tests for interactions with blood
    医疗器械生物学评价 第4部分: 与血液相互作用试验选择
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.15-2003 Biological evaluation of Medical Devices--Part 15:Identification and quantification of degradation products from metals and alloys
    医疗器械生物学评价 第15部分:金属与合金降解产物的定性与定量
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.14-2003 Biological evaluation of Medical Devices--Part 14:Identification and quantification of degradation products from ceramics
    医疗器械生物学评价 第14部分:陶瓷降解产物的定性与定量
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.9-2001 Biological evaluation of Medical Devices--Part 9:Framework for identification and quantification of potential degradation product
    医疗器械生物学评价 第9部分:潜在降解产物的定性和定量框架
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.7-2001 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
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.13-2001 Biological evaluation of Medical Devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
    医疗器械生物学评价 第13部分:聚合物医疗器械的降解产物的定性与定量
    China National Standards
    Medical Device

    English PDF
    GB 18457-2001 Stainless steel needle tubing for manufactureof Medical Devices
    制造医疗器械用不锈钢针管
    China National Standards
    Medical Device

    English PDF
    GB 18279-2000 Medical Devices--Validation androutine control of ethylene oxide sterilization
    医疗器械 环氧乙烷灭菌 确认和常规控制
    China National Standards
    Medical Device

    English PDF
    GB/T 16886.6-1997 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
    China National Standards
    Medical Device

    English PDF

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