China National Standards

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
    YY/T 1805.3-2022 Tissue engineering Medical Device products - Collagen - Part 3: Detection of collagen content based on the determination of characteristic peptides - Liquid chromatography-mass spectrometry
    组织工程医疗器械产品 胶原蛋白 第3部分:基于特征多肽测定的胶原蛋白含量检测——液相色谱-质谱法
    Medical Device
    China Pharmaceutics Industry Standards

    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
    Medical Device
    China GB-National Standards

    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
    Medical Device
    China GB-National Standards

    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
    Medical Device
    China GB-National Standards

    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
    Medical Device
    China GB-National Standards

    English PDF
    YY/T 0595-2020 Medical Devices—Application of risk management to medical devices
    医疗器械 质量管理体系YY/T 0287-2017 应用指南
    Medical Device
    China YY-Medicine & Medical Device Industry Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    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
    Medical Device
    China National Standards

    English PDF
    YY/T 0052-1991 (Change the way the Medical Device product design and design documents)
    医疗器械产品图样及设计文件的更改方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0051-1991 (The integrity of the Medical Device product design and its main design file)
    医疗器械产品图样及其主要设计文件的完整性
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0050-1991 (Medical Device product design and design principles File No.)
    医疗器械产品图样及设计文件编号原则
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0049-1991 (Medical Device product design and design file formats)
    医疗器械产品图样及设计文件格式
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0048-1991 (The basic requirements for Medical Devices work pattern)
    医疗器械产品工作图样的基本要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0047-1991 (The term Medical Device product design and design documents)
    医疗器械产品图样及设计文件的术语
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0288-1996 Quality system. Medical Devices. Particular requirements for the application of GB/T 19002. ISO 9002
    质量体系 医疗器械 gb/t 19002-iso 9002应用的专用要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0287-1996 Quality system—Medical Devices—Particular requirements for the application of GB/T 19001—ISO 9001
    质量体系 医疗器械 gb/t 19001-iso 9001应用的专用要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0297-1997 Clinical investigation of Medical Devices
    医疗器械临床调查
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 91051-1999 System table for standard of Medical Devices
    医疗器械行业标准体系表
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 91050-1999 Editorial method for design documents of Medical Device products
    医疗器械产品设计文件的编写方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY 91055-1999 Paint coating for Medical Devices. Classification and specification
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0316-2000 Medical Devices. Risk management. Part 1: Application of risk analysis
    医疗器械 风险管理 第1部分:风险分析的应用
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 1000.2-2005 Development of Medical Devices industrial standards. Part 2: Guidance for work
    医疗器械行业标准的制定 第2部分:工作指南
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 1000.1-2005 Development of Medical Devices industrial standards. Part 1: Stage division, code and procedure
    医疗器械行业标准的制定第1部分:阶段划分、代码和程序
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0639-2008 In Vitro Diagnostic Medical Devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
    体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    体外诊断医疗器械 生物样品中量的测量 校准品和控制物质中酶催化浓度赋值的计量学溯源性
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY 0033-2000 Good manufacture practice for sterile Medical Devices
    无菌医疗器具生产管理规范
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0268-2001 Dentistry--Preclinical evaluation of biocompatibility of Medical Devices used in dentistry--Part 1: Evaluation and test methods selection
    牙科学 用于口腔的医疗器械生物相容性临床前评价 第1单:评价与试验项目选择
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    牙科学 用于口腔的医疗器械生物相容性临床前评价 第2单:口腔材料生物 试验方法 盖髓试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0468-2003 Nomenclature-Specification for a nomenclature system for Medical Devices for the purpose of regulatory data exchange
    命名 用于管理资料交流的医疗器械命名系统规范
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    医疗器械 保障医疗器械安全和性能公认基本原则的标准选用指南
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0316-2003 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
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0287-2003 Medical Devices. Quality management systems. Requirements for regulatory purposes
    医疗器械 质量管理体系 用于法规的要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY 0466-2003 Medical Devices-Symbols to be used with medical device labels, labelling and information to be supplied
    医疗器械 用于医疗器械标签、标记和提供信息的符号
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0316-2008 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
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0268-2008 Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 1: Evaluation and test
    牙科学 口腔医疗器械生物学评价 第1单元:评价与试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0127.12-2008 Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Micronucleus test
    牙科学口腔医疗器械生物学评价 第2单元:试验方法微核试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0595-2006 Medical Devices. Quality management systems. Guidance on the application of YY/T0287-2003
    医疗器械 质量管理体系 yy/t 0287-2003 应用指南
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0615.2-2007 Requirements for Medical Devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices
    标示“无菌”医疗器械的要求第2部分:无菌加工医疗器械的要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0615.1-2007 Requirements for Medical Devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices
    标示无菌医疗器械的要求第1部分:最终灭菌医疗器械的要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    临床实验室测试和体外医疗器械 口服抗凝药治疗自测体外监测系统的要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0664-2008 Medical Device software. Software life cycle processes
    医疗器械软件 软件生存周期过程
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    动物源医疗器械 第3部分:病毒和传播性海绵状脑病(tse)因子去除与灭活的确认
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0771.2-2009 Medical Devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handling
    动物源医疗器械 第2部分:来源、收集与处置的控制
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0771.1-2009 Medical Devices utilizing animal tissues and their derivatives. Part 1: Application of risk management
    动物源医疗器械 第1部分 风险管理应用
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0806-2010 Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other Medical Devices
    医用输液、输血、注射及其他医疗器械用聚碳酸酯专用料
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0802-2010 Sterilization of Medical Devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
    医疗器械的灭菌 制造商提供的处理可重复灭菌医疗器械的信息
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第9部分:可密封组合袋、卷材和盖材生产用无涂胶聚烯烃非织造布材料 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第8部分:蒸汽灭菌器用重复性使用灭菌容器 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第7部分:环氧乙烷或辐射灭菌屏障系统生产用可密封涂胶纸 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第6部分:用于低温灭菌过程或辐射灭菌的无菌屏障系统生产用纸 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第5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 Medicine & Medical Device Standards

    English PDF
    YY/T 0698.4-2009 Packaging materials for terminal sterilized Medical Devices. Part 4: Paper bags. Requirements and test methods
    最终灭菌医疗器械包装材料 第4部分:纸袋 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第3部分:纸袋(yy/t 0698.4所规定)、组合带和卷材(yy/t 0698.5所规定)生产用纸 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0698.2-2009 Packaging materials for terminal sterilized Medical Devices. Part 2: Sterilization wrap. Requirements and test methods
    最终灭菌医疗器械包装材料 第2部分:灭菌包裹材料 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第10部分:可密封组合袋、卷材和盖材生产用涂胶聚烯烃非织造布材料 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.1-2009 Test methods for sterile Medical Device package. Part 1: Test guide for accelerated aging
    无菌医疗器械包装试验方法 第1部分:加速老化试验指南
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    病人、医护人员和器械用手术单、手术衣和洁净服 第6部分:阻湿态微生物穿透试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    口腔医疗器械生物学评价 第2单元: 试验方法 细胞毒性试验:琼脂扩散法及滤膜扩散法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0127.4-2009 Biological evaluation of Medical Devices used in dentistry - Part 2: Test method - Bone implant test
    口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0127.2-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute systemic toxicity:intravenous path
    口腔医疗器械生物学评价 第2单元:试验方法 急性全身毒性试验:静脉途径
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0127.16-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. In Vitro mammalian chromosome aberration test
    口腔医疗器械生物学评价 第2单元:试验方法 哺乳动物细胞体外染色体畸变试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    口腔医疗器械生物学评价 第2单元:试验方法 亚急性和亚慢性全身毒性试验:经口途径
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0127.14-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute oral toxicity test
    口腔医疗器械生物学评价 第2单元:试验方法 急性经口全身毒性试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0127.13-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Tset method. Oral mucous membrane irritation test
    口腔医疗器械生物学评价 第2单元:试验方法 口腔粘膜刺激试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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)
    口腔医疗器械生物学评价 第2单元:试验方法 鼠伤寒沙门氏杆菌回复突变试验(ames试验)
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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)
    无菌医疗器械包装试验方法 第5部分:内压法检测粗大泄漏(气泡法)
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.4-2010 Test methods for sterile Medical Device package. Part 4: Detecting seal leaks in porous packages by dye penetration
    无菌医疗器械包装试验方法 第4部分:染色液穿透法测定透气包装的密封泄漏
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.3-2010 Test methods for sterile Medical Device package. Part 3: Internal pressurization failure resistance of unrestrained packages
    无菌医疗器械包装试验方法 第3部分:无约束包装抗内压破坏
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.2-2010 Test methods for sterile Medical Device package. Part 2: Seal strength of flexible battier materials
    无菌医疗器械包装试验方法 第2部分:软性屏障材料的密封强度
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    最终灭菌医疗器械包装材料 第1部分:吸塑包装共挤塑料膜 要求和试验方法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    无菌医疗器械包装试验方法 第9部分:约束板内部气压法软包装密封胀破试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.8-2011 Test methods for sterile Medical Device package. Part 8: Coating/adhesive weight determination
    无菌医疗器械包装试验方法 第8部分:涂胶层重量的测定
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    无菌医疗器械包装试验方法 第7部分:用胶带评价软包装材料上印墨或涂层附着性
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    无菌医疗器械包装试验方法 第6部分:软包装材料上印墨和涂层抗化学性评价
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.10-2011 Test methods for sterile Medical Device package. Part 10: Test for microbial barrier ranking of porous package material
    无菌医疗器械包装试验方法 第10部分:透气包装材料微生物屏障分等试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0879.1-2013 Test for sensitization of Medical Devices. Part 1: Murine local lymph node assay(LINA):Radioisotope incorporation method
    医疗器械致敏反应试验 第1部分:小鼠局部淋巴结试验(llna)放射性同位素掺入法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0878.1-2013 Test for complement activation of Medical Devices. Part:Serum whole complement activation
    医疗器械补体激活试验 第1部分:血清全补体激活
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0870.3-2013 Test for genotoxicity of Medical Devices. Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
    医疗器械遗传毒性试验 第3部分:用小鼠淋巴瘤细胞进行的体外哺乳动物细胞基因突变试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0870.2-2013 Test for genotoxicity of Medical Devices. Part 2: In vitro mammalian chromosome aberration test
    医疗器械遗传毒性试验 第2部分:体外哺乳动物染色体畸变试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0870.1-2013 Test for genotoxicity of Medical Devices. Part 1: Bacterial reverse mutation test
    医疗器械遗传毒性试验 第1部分:细菌回复突变试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0869-2013 Medical Devices. Coding structure for adverse event type and cause
    医疗器械不良事件类型和原因的编码结构
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY 0970-2013 Sterilization of single- use Medical Devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
    含动物源材料的一次性使用医疗器械的灭菌液体灭菌剂灭菌的确认与常规控制
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0993-2015 Biological evaluation of Medical Devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
    医疗器械生物学评价 纳米材料:体外细胞毒性试验(mtt试验和ldh试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0879.2-2015 Test for hypersensitivity of Medical Devices. Part 2:Marine Local Lymph Node Assay (LLNA): BrdU-ELISA method
    医疗器械致敏反应试验 第2部分:小鼠局部淋巴结试验(llna)brdu-elisa法
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0878.2-2015 Test for complement activation of Medical Devices. Part 2: Serum alternative pathway complement activation
    医疗器械补体激活试验 第2部分:血清旁路途径补体激活
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    动物源医疗器械 第4部分:传播性海绵状脑病(tse)因子的去除和/或灭活及其过程确认分析的原则
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0468-2015 Medical Devices. Quality management. Medical device nomenclature data structure
    医疗器械 质量管理 医疗器械术语系统数据结构
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    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
    医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分:符号的制订、选择和确认
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0927-2014 Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC Medical Devices
    聚氯乙烯医疗器械中邻苯二甲酸二(2-乙基己基)酯(DEHP)溶出量测定指南
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0926-2014 Quantitative analysis of DEHP in PVC Medical Devices
    医用聚氯乙烯医疗器械中邻苯二甲酸二(2-乙基己基)酯(DEHP)的定量分析
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0870.5-2014 Test for genotoxicity of Medical Devices. Part 5: Mammalian bone marrow chromosome aberration test
    医疗器械遗传毒性试验 第5部分:哺乳动物骨髓染色体畸变试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0870.4-2014 Test for genotoxicity of Medical Devices. Part 4:Mammalian bone marrow erythocyte micronucleus test
    医疗器械遗传毒性试验 第4部分:哺乳动物骨髓红细胞微核试验
    Medical Device
    China Medicine & Medical Device Standards

    English PDF
    YY/T 0681.13-2014 Test methods for sterile Medical Device package. Part 13: Slow rate penetration resistance of flexible barrier films and laminates
    无菌医疗器械包装试验方法 第13部分:软性屏障膜和复合膜抗慢速戳穿性
    Medical Device
    China Medicine & Medical Device Standards

    English PDF

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