China Medical Device GB Standards English PDF 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 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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