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 1754.1-2020	Preclinical animal research for Medical Devices Part 1: General requirements 医疗器械临床前动物研究第1部分：通用要求	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1744-2020	Tissue engineered Medical Device products Bioactive ceramics Measurement method of cell migration in porous materials 组织工程医疗器械产品生物活性陶瓷多孔材料中细胞迁移的测量方法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1737-2020	Analytical Methods for Bioburden Control Levels of Medical Devices 医疗器械生物负载控制水平的分析方法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0664—2020	Medical Device Software Software Lifecycle Process 医疗器械软件软件生存周期过程	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1716-2020	Tissue engineered Medical Device products Characterization of ceramic and mineral scaffolds 组织工程医疗器械产品陶瓷和矿物质支架的表征	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1698-2020	Medical Devices for human in vitro assisted reproductive technology 人类体外辅助生殖技术用医疗器械辅助生殖穿刺取卵针	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0802—2020	Handling of Medical Devices Information provided by medical device manufacturers 医疗器械的处理医疗器械制造商提供的信息	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1753-2020	Guidelines for Filling in the Database of Unique Identification of Medical Devices 医疗器械唯一标识数据库填报指南	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1752-2020	Medical Device Unique Identification Database Basic Data Set 医疗器械唯一标识数据库基本数据集	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1718-2020	Medical Devices for human in vitro assisted reproductive technology Embryo transfer catheter 人类体外辅助生殖技术用医疗器械胚胎移植导管	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1695-2020	Medical Devices for human assisted reproductive technology - Method for the detection of amino acids in culture fluids 人类辅助生殖技术用医疗器械培养用液中氨基酸检测方法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0771.2—2020	Medical Devices of Animal Origin Part 2: Control of Source, Collection and Disposal 动物源医疗器械第2部分：来源、收集与处置的控制	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0771.1—2020	Medical Devices of Animal Origin Part 1: Risk Management Applications 动物源医疗器械第1部分：风险管理应用	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.18-2020	Test methods for packaging of sterile Medical Devices - Part 18: Non-destructive testing of packaging for leaks by the vacuum decay method 无菌医疗器械包装试验方法第18部分：用真空衰减法无损检验包装泄漏	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1707-2020	Surgical implants - Differential scanning calorimetry of polyetheretherketone polymers and their composites for implantable Medical Devices 外科植入物植入医疗器械用聚醚醚酮聚合物及其复合物的差示扫描量热法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1699-2020	Tissue Engineering Medical Device Products Chitosan 组织工程医疗器械产品壳聚糖	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0734.5-2020	Washer-disinfectors - Part 5: Washer-disinfectors for chemical disinfection of non-intrusive Medical Devices not resistant to high temperatures - Requirements and tests 清洗消毒器第5部分：对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器要求和试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0595-2020	Medical Device Quality Management System YY/T 0287-2017 Application Guide 医疗器械质量管理体系YY/T 0287-2017 应用指南	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1681—2019	Basic terms of Medical Device unique identification system 医疗器械唯一标识系统基础术语	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1670.1—2019	Neurotoxicity evaluation of Medical Devices Part 1: Guidelines for selection of tests for evaluating potential neurotoxicity 医疗器械神经毒性评价第1部分：评价潜在神经毒性的试验选择指南	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1465.6—2019	Methods for evaluating the immunogenicity of Medical Devices - Part 6: Determination of animal spleen lymphocyte subsets by flow cytometry 医疗器械免疫原性评价方法第6部分：用流式细胞术测定动物脾脏淋巴细胞亚群	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0878.3—2019	Complement activation test for Medical Devices Part 3: Determination of complement activation products (C3a and SC5b-9) 医疗器械补体激活试验第3部分：补体激活产物（C3a和SC5b-9）的测定	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0870.6—2019	Genotoxicity testing of Medical Devices - Part 6: In vitro mammalian cell micronucleus test 医疗器械遗传毒性试验第6部分：体外哺乳动物细胞微核试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0870.3—2019	Medical Device genotoxicity testing Part 3: TK gene mutation testing with 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TK基因突变试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0639—2019	In Vitro Diagnostic Medical Devices Manufacturer's Information for In Vitro Diagnostic Reagents for Biological Staining 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 Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1654—2019	Tissue Engineering Medical Device Products Sodium Alginate 组织工程医疗器械产品海藻酸钠	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1651.1—2019	Hemolysis test for Medical Devices - Part 1: Material-mediated hemolysis test 医疗器械溶血试验第1部分：材料介导的溶血试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1649.1—2019	Interaction test between Medical Device and platelets - Part 1: In vitro platelet count method 医疗器械与血小板相互作用试验第1部分：体外血小板计数法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0870.2—2019	Medical Device genotoxicity test - Part 2: In vitro mammalian cell chromosomal aberration test 医疗器械遗传毒性试验第2部分：体外哺乳动物细胞染色体畸变试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.16—2019	Test methods for packaging of sterile Medical Devices - Part 16: Test for climatic resilience of packaging systems 无菌医疗器械包装试验方法第16部分:包装系统气候应变能力试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1649.2-2019	Medical Device and platelet interaction test Part 2: Determination of platelet activation products (β-TG, PF4 and TxB2) in vitro 医疗器械与血小板相互作用试验第2部分：体外血小板激活产物（β-TG、PF4和TxB2）的测定	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.17-2019	Test methods for packaging of sterile Medical Devices - Part 17: Microbial barrier testing by aerosol filtration for breathable packaging materials 无菌医疗器械包装试验方法第17部分：透气包装材料气溶胶过滤法微生物屏障试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.15-2019	Sterile Medical Device packaging test methods - Part 15: Performance testing of shipping containers and systems 无菌医疗器械包装试验方法第15部分：运输容器和系统的性能试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1406.1-2016	Medical Device software—Part 1:Guidance on the application of YY/T 0316 to medical device software 医疗器械软件第1部分:YY/T0316应用于医疗器械软件的指南	China YY-Medicine & Medical Device Industry Standards Medical Device	English PDF
YY/T 1402-2016	(Medical Devices steam sterilization process challenge device applicability of test methods) 医疗器械蒸汽灭菌过程挑战装置适用性的测试方法	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1276-2016	(Development of Medical Devices dry heat sterilization process, validation and routine control) 医疗器械干热灭菌过程的开发、确认和常规控制要求	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0972-2016	(Active implantable Medical Devices implanted pacemaker device with a four-pole connector system size and test requirements) 有源植入医疗器械植入式心律调节设备用四极连接器系统尺寸和试验要求	China Medicine & Medical Device Standards Medical Device	English PDF
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) 手术植入物有源植入医疗器械第6部分：治疗快速性心律失常的有源植入医疗器械（包括植入式除颤器）的专用要求	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1474-2016	(Medical Device Usability engineering applications for medical devices) 医疗器械可用性工程对医疗器械的应用	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1465.2-2016	(Evaluation of immunological methods of Medical Devices - Part 2 serum immunoglobulins and complement components by ELISA) 医疗器械免疫原性评价方法第2部分血清免疫球蛋白和补体成分测定elisa法	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1465.1-2016	(Evaluation of immunological methods of Medical Devices - Part 1 in vitro T lymphocyte transformation test) 医疗器械免疫原性评价方法第1部分:体外t淋巴细胞转化试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1464-2016	(Development of Medical Devices - Low temperature steam sterilization formaldehyde sterilization process, validation and routine control) 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1463-2016	(Medical Device sterilization and microbial challenge to confirm the selection of site contamination Guide) 医疗器械灭菌确认选择微生物挑战和染菌部位的指南	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1454-2016	(Self-vitro diagnostic Medical Devices for detecting the basic requirements) 自我检测用体外诊断医疗器械基本要求	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1441-2016	(Performance evaluation of in vitro diagnostic Medical Devices General requirements) 体外诊断医疗器械性能评估通用要求	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1437-2016	Medical Devices—Guidance on the application of YY/T 0316 医疗器械YY/T0316应用指南	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1434-2016	(Human Assisted Reproductive Technology in vitro mouse embryo in vitro testing of Medical Devices) 人类体外辅助生殖技术用医疗器械体外鼠胚试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1433-2016	(Medical Devices flexible packaging material hot seal strength (hot tack strength) Test Method) 医疗器械软性包装材料热态密封强度（热粘强度）试验方法	China Medicine & Medical Device Standards Medical Device	English PDF
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) 通过测量热封试样的密封强度确定医疗器械软性包装材料的热封参数的试验方法	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1292.3-2016	(Reproductive and developmental toxicity of Medical Devices - Part 3: generation reproductive toxicity study) 医疗器械生殖和发育毒性试验第3部分：一代生殖毒性试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0869.2-2016	(Medical Device adverse event classification coding structure Part 2: Evaluation of coding) 医疗器械不良事件分级编码结构第2部分：评价编码	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0869.1-2016	(Medical Device adverse event classification coding structure - Part 1: Event type codes) 医疗器械不良事件分级编码结构第1部分：事件类型编码	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0467-2016	(Medical equipment to protect the safety and performance of Medical Devices accepted the basic principles of standards Selection Guide) 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	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0466.1-2016	(Symbols - Part 1 Medical Devices for medical device labels, labeling and information: 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	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0316-2016	(Medical Device Risk Management for Medical Device Applications) 医疗器械风险管理对医疗器械的应用	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0127.18-2016	(Oral Biological evaluation of Medical Devices - Part 18: dentin barrier Cytotoxicity test) 口腔医疗器械生物学评价第18部分：牙本质屏障细胞毒性试验	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1295-2015	Biological evaluation of Medical Devices. Nanomaterial: Endotoxin test 医疗器械生物学评价纳米材料：细菌内毒素试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1292.2-2015	Test for reproductive and developmental toxicity of Medical Devices. Part 2:Prenatal developmental toxicity test 医疗器械生殖和发育毒性试验第2部分:胚胎发育毒性试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1292.1-2015	Test for reproductive and developmental toxicity of Medical Devices. Part 1:Screening test 医疗器械生殖和发育毒性试验第1部分：筛选试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1267-2015	Evaluation of materials of Medical Device subject to ethylene oxide sterilization 适用于环氧乙烷灭菌的医疗器械的材料评价	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1266-2015	Evaluation of materials of Medical Device subject to hydrogen peroxide sterilization 适用于过氧化氢灭菌的医疗器械的材料评价	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1265-2015	Evaluation of materials of Medical Device subject to moist heat sterilization 适用于湿热灭菌的医疗器械的材料评价	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1264-2015	Evaluation of materials of Medical Device subject to ozone sterilization 适用于臭氧灭菌的医疗器械的材料评价	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 1263-2015	Evaluation of materials of Medical Device subject to dry heat sterilization 适用于干热灭菌的医疗器械的材料评价	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0995-2015	Medical Devices for human assisted reproductive technology. Terminology and definitions 人类辅助生殖技术用医疗器械术语和定义	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0681.12-2014	Test methods for sterile Medical Device package. Part 12: Flex durability of flexible barrier films 无菌医疗器械包装试验方法第12部分:软性屏障膜抗揉搓性	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0681.11-2014	Test methods for sterile Medical Device package. Part 11: Determining integrity of seals for medical packaging by visual inspection 无菌医疗器械包装试验方法第11部分:目力检测医用包装密封完整性	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0127.5-2014	Biological evaluation of Medical Devices used in dentistry. Part 5: Inhalation toxicity test 口腔医疗器械生物学评价第5部分:吸入毒性试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0127.3-2014	Biological evaluation of Medical Devices used in dentistry-Part 3: Endodontic usage test 口腔医疗器械生物学评价第3部分:根管内应用试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0127.17-2014	Biological evaluation of Medical Devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test 口腔医疗器械生物学评价第17部分:小鼠淋巴瘤细胞(TK)基因突变试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0127.11-2014	Biological evaluation of Medical Devices used in dentistry. Part 11: Pulp capping test 口腔医疗器械生物学评价第11部分:盖髓试验	China Medicine & Medical Device Standards Medical Device	English PDF
YY/T 0927-2014	Guidelines for Determination of Di(2-ethylhexyl) Phthalate (DEHP) Dissolution in Polyvinyl Chloride Medical Devices{译} 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	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0926-2014	Quantitative analysis of di(2-ethylhexyl) phthalate (DEHP) in medical polyvinyl chloride Medical Devices{译} 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	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0870.5-2014	Medical Device genotoxicity test - Part 5: Mammalian bone marrow chromosomal aberration test{译} 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	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0870.4-2014	Medical Device genotoxicity testing Part 4: Mammalian bone marrow erythrocyte micronucleus test{译} 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	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.13-2014	Test methods for packaging of sterile Medical Devices - Part 13: Slow puncture resistance of soft barrier films and composite films{译} 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	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.12-2014	Test methods for packaging of sterile Medical Devices - Part 12: Scrub resistance of soft barrier films{译} 无菌医疗器械包装试验方法第12部分：软性屏障膜抗揉搓性	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.11-2014	Sterile Medical Device packaging test methods - Part 11: Visual inspection of medical packaging seal integrity{译} 无菌医疗器械包装试验方法第11部分：目力检测医用包装密封完整性	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0127.17-2014	Biological Evaluation of Oral Medical Devices Part 17: Murine Lymphoma Cell (TK) Gene Mutation Test{译} 口腔医疗器械生物学评价第17部分：小鼠淋巴瘤细胞（TK）基因突变试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0127.11-2014	Biological Evaluation of Oral Medical Devices Part 11: Pulp Capping Test{译} 口腔医疗器械生物学评价第11部分：盖髓试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0127.5-2014	Biological Evaluation of Oral Medical Devices Part 5: Inhalation Toxicity Test{译} 口腔医疗器械生物学评价第5部分：吸入毒性试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0127.3-2014	Biological Evaluation of Oral Medical Devices Part 3: Endodontic Application Test{译} 口腔医疗器械生物学评价第3部分：根管内应用试验	China Pharmaceutics Industry Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	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	China Medicine & Medical Device Standards Medical Device	English PDF

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