China Medical devices Industry Standards English PDF List

China "Medical devices" Industry Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
YY/T 1842.3—2023	Medical devices - Connectors for medical liquid storage container delivery systems - Part 3: Gastrointestinal applications {译} 医疗器械医用贮液容器输送系统用连接件第3部分：胃肠道应用	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0127.19—2023	Biological evaluation of oral Medical devices Part 19: Subacute and subchronic systemic toxicity testing: Route of implantation {译} 口腔医疗器械生物学评价第19部分：亚急性和亚慢性全身毒性试验：植入途径	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0127.4—2023	Biological evaluation of oral Medical devices Part 4: Bone implant test {译} 口腔医疗器械生物学评价第4部分：骨植入试验	China Pharmaceutics Industry Standards Medical devices	English PDF
SN/T 4445.4-2023	Technical requirements for inspection of imported Medical devices Part 4: Infusion pump {译} 进口医疗器械检验技术要求第4部分：输液泵	China Import&Export Inspection Industry Standards Medical devices	English PDF
WS/T 364.16—2023	Health information data element value field code Part 16: Drugs and Medical devices {译} 卫生健康信息数据元值域代码第16部分：药品与医疗器械	China Hygiene Industry Standards Medical devices	English PDF
WS/T 363.16—2023	Health Information Data Meta Catalog Part 16: Drugs and Medical devices {译} 卫生健康信息数据元目录第16部分:药品与医疗器械	China Hygiene Industry Standards Medical devices	English PDF
YY/T 1914-2023	Medical devices for human assisted reproductive technology - General requirements for device products {译} 人类辅助生殖技术用医疗器械器具类产品通用要求	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1912-2023	Biological evaluation and testing of Medical devices for soft tissue regeneration {译} 用于软组织再生医疗器械的生物学评价与试验	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1907-2023	Artificial Intelligence Medical devices Coronary CT Image Processing Software Algorithm Performance Testing Methods {译} 人工智能医疗器械冠状动脉CT影像处理软件算法性能测试方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1833.4-2023	Artificial Intelligence Medical devices Quality Requirements and Evaluation Part 4: Traceability {译} 人工智能医疗器械质量要求和评价第4部分：可追溯性	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0698.5—2023	Packaging materials for terminally sterilized Medical devices Part 5: Sealable combination bags and rolls composed of breathable materials and plastic films Requirements and test methods {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0466.1—2023	Medical devices Symbols for information provided by manufacturers Part 1: General requirements {译} 医疗器械用于制造商提供信息的符号第1部分：通用要求	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0033-2000	Standards for Production Management of Sterile Medical devices {译} 无菌医疗器具生产管理规范	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0771.3-2009	Medical devices of animal origin Part 3: Confirmation of removal and inactivation of viral and transmissible spongiform encephalopathy (TSE) agents {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0127.16-2009	Biological Evaluation of Dental Medical devices Unit 2: Test Methods Chromosomal Aberration Test of Mammalian Cells in Vitro {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0127.4-2009	Biological Evaluation of Dental Medical devices Unit 2: Test Methods Bone Implant Test {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0127.9-2009	Biological Evaluation of Dental Medical devices Unit 2: Test Methods Cytotoxicity Test: Agar Diffusion Method and Membrane Diffusion Method {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0770.1-2009	Filter materials for medical infusion and injection devices - Part 1: Filter materials for medicinal liquid {译} 医用输、注器具用过滤材料第1部分：药液过滤材料	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0590.3-2011	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of quantum detection efficiency - Detectors for dynamic imaging {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1899-2023	Preparation and evaluation methods of histopathological samples after implantation of absorbable Medical devices {译} 可吸收医疗器械植入后组织病理学样本制备与评价方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1897-2023	Biological evaluation of nanoMedical devices Genotoxicity test In vitro mammalian cell micronucleus test {译} 纳米医疗器械生物学评价遗传毒性试验体外哺乳动物细胞微核试验	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1754.3-2023	Preclinical Animal Studies of Medical devices Part 3: Animal Model of Incisional Abdominal Hernia for Evaluation of Mesh Histological Response and Biomechanical Properties {译} 医疗器械临床前动物研究第3部分：用于评价补片组织学反应与生物力学性能的动物腹壁切口疝模型	China Pharmaceutics Industry Standards Medical devices	English PDF
YY 0989.3-2023	Surgical implants Active implantable Medical devices Part 3: Implantable neurostimulators {译} 手术植入物有源植入式医疗器械第3部分：植入式神经刺激器	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1295—2015	Biological Evaluation of Medical devices Nanomaterials: Bacterial Endotoxin Test {译} 医疗器械生物学评价纳米材料：细菌内毒素试验	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1292.2—2015	Reproductive and Developmental Toxicity Tests for Medical devices Part 2: Embryo Developmental Toxicity Tests {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1292.1—2015	Reproductive and Developmental Toxicity Tests for Medical devices Part 1: Screening Tests {译} 医疗器械生殖和发育毒性试验第1部分：筛选试验	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1267—2015	Evaluation of Materials for Medical devices Suitable for Ethylene Oxide Sterilization {译} 适用于环氧乙烷灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1266—2015	Evaluation of Materials for Medical devices Suitable for Hydrogen Peroxide Sterilization {译} 适用于过氧化氢灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1265—2015	Evaluation of Materials for Medical devices Suitable for Moist Heat Sterilization {译} 适用于湿热灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1264—2015	Material Evaluation of Medical devices Suitable for Ozone Sterilization {译} 适用于臭氧灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1263—2015	Evaluation of Materials for Medical devices Suitable for Dry Heat Sterilization {译} 适用于干热灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0995—2015	Medical devices for human assisted reproductive technology Terms and definitions {译} 人类辅助生殖技术用医疗器械术语和定义	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0993—2015	Biological Evaluation of Medical devices Nanomaterials: In Vitro Cytotoxicity Tests (MTT Test and LDH Test) {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0878.2—2015	Complement Activation Assay for Medical devices Part 2: Serum Alternative Pathway Complement Activation {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0771.4—2015	Medical devices of animal origin - Part 4: Principles for the removal and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and their process validation analysis {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0466.2—2015	Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 2: Development, selection and validation of symbols {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1874-2023	Active Implantable Medical devices - Electromagnetic Compatibility - Electromagnetic Compatibility Test Rules for Implantable Cardiac Pacemakers, Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Devices {译} 有源植入式医疗器械电磁兼容植入式心脏起搏器、植入式心律转复除颤器和心脏再同步器械的电磁兼容测试细则	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0128-2023	Medical diagnostic X-ray radiation protection equipment, devices and appliances {译} 医用诊断X射线辐射防护器具装置及用具	China Pharmaceutics Industry Standards Medical devices	English PDF
YY 0970-2023	Sterilization of healthcare products - Liquid chemical sterilants for single-use Medical devices of animal origin - Requirements for the characterization, development, validation and routine control of medical device sterilization processes {译} 医疗保健产品灭菌一次性使用动物源性医疗器械的液体化学灭菌剂医疗器械灭菌过程的特征、开发、确认和常规控制的要求	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1863-2023	Biological evaluation of nanoMedical devices Release and characterization of nanosilver particles and silver ions from nanosilver-containing dressings {译} 纳米医疗器械生物学评价含纳米银敷料中纳米银颗粒和银离子的释放与表征方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1842.7-2023	Medical devices - Connections for medical reservoir delivery systems - Part 7: Connections for intravascular infusion {译} 医疗器械医用贮液容器输送系统用连接件第7部分：血管内输液用连接件	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1473-2023	Guidelines for Standardization of Medical devices Standardization Involving Safety Content {译} 医疗器械标准化工作指南涉及安全内容的标准制定	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0870.7-2023	Genotoxicity Tests for Medical devices - Part 7: Alkaline Comet Test in Mammals {译} 医疗器械遗传毒性试验第7部分：哺乳动物体内碱性彗星试验	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1854-2022	Test method for dissolution of trioctyl trimellitate (TOTM) in polyvinyl chloride Medical devices {译} 聚氯乙烯医疗器械中偏苯三酸三辛酯（TOTM）溶出量测试方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1852-2022	Medical devices for human assisted reproductive technology Determination of ammonium ions in culture solution {译} 人类辅助生殖技术用医疗器械培养用液中铵离子的测定	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1842.6-2022	Medical devices - Connections for medical reservoir delivery systems - Part 6: Neurological applications {译} 医疗器械医用贮液容器输送系统用连接件第6部分：神经应用	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1833.3-2022	Artificial Intelligence Medical devices Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling {译} 人工智能医疗器械质量要求和评价第3部分：数据标注通用要求	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1879-2022	Creation and assignment of unique identifiers for Medical devices {译} 医疗器械唯一标识的创建和赋予	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1833.2-2022	Artificial Intelligence Medical devices Quality Requirements and Evaluation Part 2: General Requirements for Datasets {译} 人工智能医疗器械质量要求和评价第2部分：数据集通用要求	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1833.1-2022	Artificial intelligence Medical devices - Quality requirements and evaluation - Part 1: Terminology {译} 人工智能医疗器械质量要求和评价第1部分：术语	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1842.8-2022	Medical devices—Connectors for medical reservoir delivery systems—Part 8: Application of apheresis citrate anticoagulants {译} 医疗器械医用贮液容器输送系统用连接件第8部分：单采枸橼酸盐抗凝剂应用	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1842.1-2022	Medical devices - Connections for medical liquid reservoir delivery systems - Part 1: General requirements and general test methods {译} 医疗器械医用贮液容器输送系统用连接件第1部分：通用要求和通用试验方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1815-2022	Biological Evaluation of Medical devices Application of Toxicological Thresholds of Concern (TTC) to Assess the Biocompatibility of Medical Device Components {译} 医疗器械生物学评价应用毒理学关注阈值（TTC）评定医疗器械组分的生物相容性	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1769-2022	Medical devices for Human Assisted Reproductive Technology Artificial Insemination Catheters {译} 人类辅助生殖技术用医疗器械人工授精导管	China Pharmaceutics Industry Standards Medical devices	English PDF
SN/T 5473.3-2022	Technical requirements for the inspection of export Medical devices - Part 3: Infrared thermometer{译} {译} 出口医疗器械检验技术要求第3部分：红外测温仪	China Import&Export Inspection Industry Standards Medical devices	English PDF
SN/T 5473.2-2022	Technical Requirements for the Inspection of Exported Medical devices Part 2: Patient Monitors{译} {译} 出口医疗器械检验技术要求第2部分：病员监护仪	China Import&Export Inspection Industry Standards Medical devices	English PDF
SN/T 5473.1-2022	Technical Requirements for the Inspection of Exported Medical devices Part 1: Ventilators{译} {译} 出口医疗器械检验技术要求第1部分：呼吸机	China Import&Export Inspection Industry Standards Medical devices	English PDF
YY/T 0989.5-2022	Surgical implants - Active implantable Medical devices - Part 5: Circulatory support devices {译} 手术植入物有源植入式医疗器械第5部分：循环支持器械	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0698.2-2022	Packaging materials for terminally sterilized Medical devices - Part 2: Requirements and test methods for packaging materials for sterilization {译} 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 Pharmaceutics Industry Standards Medical devices	English PDF
YY 0671-2021	Medical devices Sleep Apnea Treatment Masks & App Accessories {译} 医疗器械睡眠呼吸暂停治疗面罩和应用附件	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1808-2021	In vitro skin irritation test for Medical devices {译} 医疗器械体外皮肤刺激试验	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1775.1-2021	Biological Evaluation of Absorbable Medical devices Part 1: Guidelines for Absorbable Implants {译} 可吸收医疗器械生物学评价第1部分：可吸收植入物指南	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1688-2021	Medical devices for Human Assisted Reproductive Technology-Methods for Staining and Counting Blastocyst Cells {译} 人类辅助生殖技术用医疗器械囊胚细胞染色和计数方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1465.7—2021	Methods for evaluating the immunogenicity of Medical devices Part 7: Flow-liquid-liquid multiplex protein quantification techniques {译} 医疗器械免疫原性评价方法第7部分：流式液相多重蛋白定量技术	China Pharmaceutics Industry Standards Medical devices	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	China YY-Medicine & Medical Device Industry Standards Medical devices	English PDF
YY/T 1733-2020	Radiation Sterilization of Medical devices—Guidelines for Dose Distribution Testing of Irradiation Devices {译} 医疗器械辐射灭菌辐照装置剂量分布测试指南	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1759-2020	Guidelines for Design and Evaluation of Primary Flexible Packaging for Medical devices {译} 医疗器械软性初包装设计与评价指南	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1754.2-2020	Preclinical animal studies of Medical devices Part 2: Rat skin defect model of induced diabetes {译} 医疗器械临床前动物研究第2部分:诱导糖尿病大鼠皮肤缺损模型	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1754.1-2020	Preclinical animal research for Medical devices Part 1: General requirements {译} 医疗器械临床前动物研究第1部分：通用要求	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1737-2020	Analytical Methods for Bioburden Control Levels of Medical devices {译} 医疗器械生物负载控制水平的分析方法	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1698-2020	Medical devices for human in vitro assisted reproductive technology {译} 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 devices	English PDF
YY/T 0802—2020	Handling of Medical devices Information provided by medical device manufacturers {译} 医疗器械的处理医疗器械制造商提供的信息	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1753-2020	Guidelines for Filling in the Database of Unique Identification of Medical devices {译} 医疗器械唯一标识数据库填报指南	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1718-2020	Medical devices for human in vitro assisted reproductive technology Embryo transfer catheter {译} 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 devices	English PDF
YY/T 1695-2020	Medical devices for human assisted reproductive technology - Method for the detection of amino acids in culture fluids {译} 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 devices	English PDF
YY/T 0771.2—2020	Medical devices of Animal Origin Part 2: Control of Source, Collection and Disposal {译} 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 devices	English PDF
YY/T 0771.1—2020	Medical devices of Animal Origin Part 1: Risk Management Applications {译} 动物源医疗器械第1部分：风险管理应用	China Pharmaceutics Industry Standards Medical devices	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 {译} 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 devices	English PDF
YY/T 0292.2—2020	Medical diagnostic X-ray radiation protection devices - Part 2: Transparent protective panels {译} 医用诊断X射线辐射防护器具第2部分：透明防护板	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 0292.1—2020	Medical diagnostic X-ray radiation protection devices - Part 1: Determination of the attenuation properties of materials {译} 医用诊断X射线辐射防护器具　第1部分：材料衰减性能的测定	China Pharmaceutics Industry Standards Medical devices	English PDF
YY/T 1707-2020	Surgical implants - Differential scanning calorimetry of polyetheretherketone polymers and their composites for implantable Medical devices {译} 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 devices	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 {译} 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 devices	English PDF
YY/T 1670.1—2019	Neurotoxicity evaluation of Medical devices Part 1: Guidelines for selection of tests for evaluating potential neurotoxicity {译} 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 devices	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 {译} 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 devices	English PDF
YY/T 0878.3—2019	Complement activation test for Medical devices Part 3: Determination of complement activation products (C3a and SC5b-9) {译} 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 devices	English PDF
YY/T 0870.6—2019	Genotoxicity testing of Medical devices - Part 6: In vitro mammalian cell micronucleus test {译} 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 devices	English PDF
YY/T 0639—2019	In Vitro Diagnostic Medical devices Manufacturer's Information for In Vitro Diagnostic Reagents for Biological Staining {译} 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 devices	English PDF
YY/T 1651.1—2019	Hemolysis test for Medical devices - Part 1: Material-mediated hemolysis test {译} 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 devices	English PDF
YY/T 0681.16—2019	Test methods for packaging of sterile Medical devices - Part 16: Test for climatic resilience of packaging systems {译} 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 devices	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 {译} 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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	English PDF
YY/T 0927-2014	Guidelines for Determination of Di(2-ethylhexyl) Phthalate (DEHP) Dissolution in Polyvinyl Chloride Medical devices{译} {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 devices	English PDF
YY/T 0926-2014	Quantitative analysis of di(2-ethylhexyl) phthalate (DEHP) in medical polyvinyl chloride Medical devices{译} {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 devices	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} {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 devices	English PDF
YY/T 0681.12-2014	Test methods for packaging of sterile Medical devices - Part 12: Scrub resistance of soft barrier films{译} {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 devices	English PDF
YY/T 0127.17-2014	Biological Evaluation of Oral Medical devices Part 17: Murine Lymphoma Cell (TK) Gene Mutation Test{译} {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 devices	English PDF
YY/T 0127.11-2014	Biological Evaluation of Oral Medical devices Part 11: Pulp Capping Test{译} {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 devices	English PDF
YY/T 0127.5-2014	Biological Evaluation of Oral Medical devices Part 5: Inhalation Toxicity Test{译} {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 devices	English PDF
YY/T 0127.3-2014	Biological Evaluation of Oral Medical devices Part 3: Endodontic Application Test{译} {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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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	China Medicine & Medical Device Standards Medical devices	English PDF
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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	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 devices	English PDF
YY 91055-1999	Paint coating for Medical devices. Classification and specification	China Medicine & Medical Device Standards Medical devices	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 devices	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 devices	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 devices	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 devices	English PDF

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