China Medical device Industry Standards English PDF List

China " Medical device" Industry Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
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 医用电气设备数字x射线成像装置特性第1-3部分：量子探测效率的测定动态成像用探测器	China Medicine & Medical Device Standards Medical device	English PDF
YY 0847-2011	Medical endoscopes - Endotherapy device - Stone retrieval forceps 医用内窥镜内窥镜器械取石网篮	China Medicine & Medical Device Standards Medical device	English PDF
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	China Import Export Inspection Standards Medical device	English PDF
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	China Import Export Inspection Standards Medical device	English PDF
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	China Import Export Inspection Standards Medical device	English PDF
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	China Import Export Inspection Standards Medical device	English PDF
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	China Import Export Inspection Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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）	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 0590.2-2010	Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-2:Determination of the detective quantum efficiency. Detectors used in mammography 医用电气设备数字x射线成像装置特性第1-2部分：量子探测效率的测定乳腺x射线摄影用探测器	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 0202-2009	Specifications for medical diagnostic X-ray device for tomography 医用诊断x射线体层摄影装置技术条件	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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）	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 0606.10-2008	Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage 组织工程医疗产品第10部分：修复或再生关节软骨植入物的体内评价指南	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY 0600.1-2007	Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices 医用呼吸机基本安全和主要性能专用要求第1部分：家用呼吸支持设备	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 0590.1-2005	Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency 医用电气设备数字x射线成像装置特性第1部分:量子探测效率的测定	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 0128-2004	Protective devices against diagnostic medical X-radiation. Device and tool 医用诊断x射线辐射防护器具装置及用具	China Medicine & Medical Device Standards Medical device	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	China Medicine & Medical Device Standards Medical device	English PDF
YY 0033-2000	Good manufacture practice for sterile Medical devices 无菌医疗器具生产管理规范	China Medicine & Medical Device Standards Medical device	English PDF
YY 0318-2000	Protective device against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads 医用诊断x射线辐射防护器具第3部分：防护服和性腺防护器具	China Medicine & Medical Device Standards Medical device	English PDF
YY 91055-1999	Paint coating for Medical devices. Classification and specification	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 91051-1999	System table for standard of Medical devices 医疗器械行业标准体系表	China Medicine & Medical Device Standards Medical device	English PDF
YY/T 0297-1997	Clinical investigation of Medical devices 医疗器械临床调查	China Medicine & Medical Device Standards Medical device	English PDF
YY 0292.2-1997	Protective devices against diagnostic medical X-radiation. Part 2: Protective glass plates 医用诊断x射线辐射防护器具第二部分:防护玻璃板	China Medicine & Medical Device Standards Medical device	English PDF
YY 0292.1-1997	Protective devices against diagnostic medical X-radiation. Part 1: Determination of attenuation properties of materials 医用诊断x射线辐射防护器具第一部分:材料衰减性能的测定	China Medicine & Medical Device Standards Medical device	English PDF

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