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
GB/T 18280.3-2025	Sterilization of Medical Devices - Radiation - Part 3: Guidelines for Dose Measurement in Development, Validation, and Routine Control 医疗产品灭菌 - 辐射 - 第3部分：开发、确认和常规控制的剂量测量指南	China National Standards Medical Device	English PDF
GB/T 18280.2-2025	Sterilization of Medical Devices - Radiation - Part 2: Establishment of Sterilizing Dose 医疗产品灭菌 - 辐射 - 第2部分：建立灭菌剂量	China National Standards Medical Device	English PDF
GB 18280.1-2025	Sterilization of Medical Products - Radiation - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices 医疗产品灭菌 - 辐射 - 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求	China National Standards Medical Device	English PDF
GB/T 46147-2025	Biological Evaluation of Medical Devices - Measurement of Nanoparticle Shedding and Release - Particle Tracking Analysis Method 医疗器械生物学评价 - 纳米颗粒脱落和释放测量 - 颗粒跟踪分析法	China National Standards Medical Device	English PDF
GB/T 16886.17-2025	Biological Evaluation of Medical Devices - Part 17: Toxicological Risk Assessment of Medical Device Components 医疗器械生物学评价-第17部分：医疗器械成分的毒理学风险评估	China National Standards Medical Device	English PDF
GB/T 21415-2025	In vitro diagnostic Medical Devices - Requirements for establishing the metrological traceability of calibration materials, accuracy control substances and human specimens 体外诊断医疗器械 - 建立校准品、正确度控制物质和人体样品赋值的计量溯源性要求	China National Standards Medical Device	English PDF
GB/T 45351-2025	Cell-Based Medical Device Manufacturing - Microbiological Risk Control During Processing 基于细胞的医疗器械生产-加工过程中微生物风险控制	China National Standards Medical Device	English PDF
GB/Z 44877-2024	Sterilization of Medical Devices - Guidelines for release of parameters for ethylene oxide sterilization processes 医疗器械灭菌-环氧乙烷灭菌过程参数放行指南	China National Standards Medical Device	English PDF
GB/T 44585.1-2024	Application of risk management in Medical Devices connected to IT networks - Part 1: Safety, effectiveness and network security of networked medical devices or health software in their implementation and use 风险管理在接入IT网络的医疗器械中的应用-第1部分：联网医疗器械或健康软件在其实施和使用中的安全、有效性和网络安全	China National Standards Medical Device	English PDF
GB/T 44586.1-2024	In vitro diagnostic Medical Devices-Multiple nucleic acid molecular detection-Part 1: Nucleic acid quality evaluation terms and general requirements 体外诊断医疗器械-多重核酸分子检测-第1部分：核酸质量评价术语和通用要求	China National Standards Medical Device	English PDF
GB/T 44672-2024	In vitro diagnostic Medical Devices - Establishment of calibration products and human samples Requirements for internationally consistent schemes for assigning metrological traceability 体外诊断医疗器械-建立校准品和人体样品赋值计量溯源性的国际一致化方案的要求	China National Standards Medical Device	English PDF
GB 16174.1-2024	Surgical implants-Active implantable Medical Devices-Part 1: General requirements for safety, marking and information provided by manufacturers 手术植入物-有源植入式医疗器械-第1部分：安全、标记和制造商所提供信息的通用要求	China National Standards Medical Device	English PDF
GB 16174.2-2024	Surgical implants-Active implantable Medical Devices-Part 2: Pacemakers 手术植入物-有源植入式医疗器械-第2部分：心脏起搏器	China National Standards Medical Device	English PDF
GB/Z 44363-2024	Pyrogenicity - Principles and methods of pyrogenicity testing for Medical Devices 致热性-医疗器械热原试验的原理和方法	China National Standards Medical Device	English PDF
GB/T 44353.2-2024	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 National Standards Medical Device	English PDF
GB/T 44353.1-2024	Medical Devices of animal origin - Part 1: Risk management application - 动物源医疗器械-第1部分：风险管理应用-	China National Standards Medical Device	English PDF
GB/T 16886.10-2024	Biological evaluation of Medical Devices - Part 10: Skin sensitization test 医疗器械生物学评价-第10部分：皮肤致敏试验	China National Standards Medical Device	English PDF
GB/T 18457-2024	Stainless steel needles for Medical Devices - Requirements and test methods 制造医疗器械用不锈钢针管-要求和试验方法	China National Standards Medical Device	English PDF
GB/T 19633.2-2024	Terminally sterilized Medical Device packaging - Part 2: Requirements for confirmation of molding, sealing and assembly processes 最终灭菌医疗器械包装-第2部分：成型、密封和装配过程的确认的要求	China National Standards Medical Device	English PDF
GB/T 19633.1-2024	Terminally sterilized Medical Device packaging - Part 1: Requirements for materials, sterile barrier systems and packaging systems 最终灭菌医疗器械包装-第1部分：材料、无菌屏障系统和包装系统的要求	China National Standards Medical Device	English PDF
GB/T 16886.23-2023	Biological evaluation of Medical Devices Part 23: Stimulation test 医疗器械生物学评价第23部分：刺激试验	China National Standards Medical Device	English PDF
GB/T 16886.12-2023	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	China National Standards Medical Device	English PDF
YY/T 1842.3—2023	Medical Devices - Connectors for medical liquid storage container delivery systems - Part 3: Gastrointestinal applications 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 Device	English PDF
YY/T 0127.19—2023	Biological evaluation of oral Medical Devices Part 19: Subacute and subchronic systemic toxicity testing: Route of implantation 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 Device	English PDF
YY/T 0127.4—2023	Biological evaluation of oral Medical Devices Part 4: Bone implant test 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 Device	English PDF
SN/T 4445.4-2023	Technical requirements for inspection of imported Medical Devices Part 4: Infusion pump 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 Device	English PDF
WS/T 364.16—2023	Health information data element value field code Part 16: Drugs and Medical Devices 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 Device	English PDF
WS/T 363.16—2023	Health Information Data Meta Catalog Part 16: Drugs and Medical Devices 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 Device	English PDF
YY/T 1914-2023	Medical Devices for human assisted reproductive technology - General requirements for device products 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 Device	English PDF
YY/T 1912-2023	Biological evaluation and testing of Medical Devices for soft tissue regeneration 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 Device	English PDF
YY/T 1911-2023	Medical Device coagulation test methods 医疗器械凝血试验方法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1907-2023	Artificial Intelligence Medical Devices Coronary CT Image Processing Software Algorithm Performance Testing Methods 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 Device	English PDF
YY/T 1833.4-2023	Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 4: Traceability 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 Device	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 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 Device	English PDF
YY/T 0466.1—2023	Medical Devices Symbols for information provided by manufacturers Part 1: General requirements 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 Device	English PDF
GB 18279-2023	Sterilization of healthcare products Ethylene oxide Requirements for the development, validation and routine control of Medical Device sterilization processes 医疗保健产品灭菌环氧乙烷医疗器械灭菌过程的开发、确认和常规控制要求	China National Standards Medical Device	English PDF
YY/T 0033-2000	Standards for Production Management of Sterile Medical Devices 无菌医疗器具生产管理规范	China Pharmaceutics Industry Standards Medical Device	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 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 Device	English PDF
YY/T 91051-1999	Medical Device industry standard system table 医疗器械行业标准体系表	China Pharmaceutics Industry Standards Medical Device	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 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 Device	English PDF
YY/T 0127.4-2009	Biological Evaluation of Dental Medical Devices Unit 2: Test Methods 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 Pharmaceutics Industry Standards Medical Device	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 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 Device	English PDF
YY/T 1899-2023	Preparation and evaluation methods of histopathological samples after implantation of absorbable Medical Devices 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 Device	English PDF
YY/T 1897-2023	Biological evaluation of nanoMedical Devices Genotoxicity test In vitro mammalian cell micronucleus test 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 Device	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 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 Device	English PDF
YY/T 1437-2023	Medical Device GB/T 42062 Application Guide 医疗器械 GB/T 42062应用指南	China Pharmaceutics Industry Standards Medical Device	English PDF
YY 0989.3-2023	Surgical implants Active implantable Medical Devices Part 3: Implantable neurostimulators 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 Device	English PDF
YY/T 0468-2015	Medical Device quality management medical device terminology system data structure 医疗器械质量管理医疗器械术语系统数据结构	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1295—2015	Biological Evaluation of Medical Devices Nanomaterials: Bacterial Endotoxin Test 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 Device	English PDF
YY/T 1292.2—2015	Reproductive and Developmental Toxicity Tests for Medical Devices Part 2: Embryo Developmental Toxicity Tests 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 Device	English PDF
YY/T 1292.1—2015	Reproductive and Developmental Toxicity Tests for Medical Devices Part 1: Screening Tests 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 Device	English PDF
YY/T 1267—2015	Evaluation of Materials for Medical Devices Suitable for Ethylene Oxide Sterilization 适用于环氧乙烷灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1266—2015	Evaluation of Materials for Medical Devices Suitable for Hydrogen Peroxide Sterilization 适用于过氧化氢灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1265—2015	Evaluation of Materials for Medical Devices Suitable for Moist Heat Sterilization 适用于湿热灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1264—2015	Material Evaluation of Medical Devices Suitable for Ozone Sterilization 适用于臭氧灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1263—2015	Evaluation of Materials for Medical Devices Suitable for Dry Heat Sterilization 适用于干热灭菌的医疗器械的材料评价	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0995—2015	Medical Devices for human assisted reproductive technology Terms and definitions 人类辅助生殖技术用医疗器械术语和定义	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0993—2015	Biological Evaluation of Medical Devices Nanomaterials: In Vitro Cytotoxicity Tests (MTT Test and LDH Test) 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 Device	English PDF
YY/T 0879.2—2015	Medical Device sensitization test Part 2: Mouse 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 Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0878.2—2015	Complement Activation Assay for 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 Pharmaceutics Industry Standards Medical Device	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 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 Device	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 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 Device	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 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 Device	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 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 Device	English PDF
YY/T 1863-2023	Biological evaluation of nanoMedical Devices Release and characterization of nanosilver particles and silver ions from nanosilver-containing dressings 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 Device	English PDF
YY/T 1842.7-2023	Medical Devices - Connections for medical reservoir delivery systems - Part 7: Connections for intravascular infusion 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 Device	English PDF
YY/T 1473-2023	Guidelines for Standardization of Medical Devices Standardization Involving Safety Content 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 Device	English PDF
YY/T 0870.7-2023	Genotoxicity Tests for Medical Devices - Part 7: Alkaline Comet Test in Mammals 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 Device	English PDF
YY/T 1854-2022	Test method for dissolution of trioctyl trimellitate (TOTM) in polyvinyl chloride Medical Devices 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 Device	English PDF
YY/T 1852-2022	Medical Devices for human assisted reproductive technology Determination of ammonium ions in culture solution 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 Device	English PDF
YY/T 1842.6-2022	Medical Devices - Connections for medical reservoir delivery systems - Part 6: Neurological applications 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 Device	English PDF
YY/T 1833.3-2022	Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling 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 Device	English PDF
YY/T 1879-2022	Creation and assignment of unique identifiers for Medical Devices 医疗器械唯一标识的创建和赋予	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1833.2-2022	Artificial Intelligence Medical Devices Quality Requirements and Evaluation Part 2: General Requirements for Datasets 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 Device	English PDF
YY/T 1833.1-2022	Artificial intelligence Medical Devices - Quality requirements and evaluation - Part 1: Terminology 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 Device	English PDF
YY/T 1842.8-2022	Medical Devices—Connectors for medical reservoir delivery systems—Part 8: Application of apheresis citrate anticoagulants 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 Device	English PDF
YY/T 1842.1-2022	Medical Devices - Connections for medical liquid reservoir delivery systems - Part 1: General requirements and general test methods 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 Device	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 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 Device	English PDF
YY/T 1769-2022	Medical Devices for Human Assisted Reproductive Technology Artificial Insemination Catheters 人类辅助生殖技术用医疗器械人工授精导管	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0681.12-2022	Test methods for sterile Medical Device packaging - Part 12: Soft barrier materials rub resistance 无菌医疗器械包装试验方法第12部分：软性屏障材料抗揉搓性	China Pharmaceutics Industry Standards Medical Device	English PDF
SN/T 5473.3-2022	Technical requirements for the inspection of export Medical Devices - Part 3: Infrared thermometer{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 Device	English PDF
SN/T 5473.2-2022	Technical Requirements for the Inspection of Exported Medical Devices Part 2: Patient Monitors{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 Device	English PDF
SN/T 5473.1-2022	Technical Requirements for the Inspection of Exported Medical Devices Part 1: Ventilators{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 Device	English PDF
YY/T 1464-2022	Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of Medical Device sterilization processes 医疗保健产品灭菌低温蒸汽甲醛医疗器械灭菌过程的开发、确认和常规控制要求	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 0989.5-2022	Surgical implants - Active implantable Medical Devices - Part 5: Circulatory support devices 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 Device	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 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 Device	English PDF
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{译} 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	China Pharmaceutics Industry Standards Medical Device	English PDF
YY 0671-2021	Medical Devices Sleep Apnea Treatment Masks & App Accessories 医疗器械睡眠呼吸暂停治疗面罩和应用附件	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1808-2021	In vitro skin irritation test for Medical Devices 医疗器械体外皮肤刺激试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1805.2-2021	Tissue Engineering Medical Device Products-Collagen Part 2: Molecular Weight Detection of Type I Collagen-Sodium Lauryl Sulfate Polyacrylamide Gel Electrophoresis 组织工程医疗器械产品胶原蛋白第2部分：I型胶原蛋白分子量检测-十二烷基硫酸钠聚丙烯酰胺凝胶电泳法	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1775.1-2021	Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants 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 Device	English PDF
YY/T 1770.1-2021	Medical Device Thrombosis Test Part 1: In Vivo Thrombosis Test in Dogs 医疗器械血栓形成试验第1部分：犬体内血栓形成试验	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1688-2021	Medical Devices for Human Assisted Reproductive Technology-Methods for Staining and Counting Blastocyst Cells 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 Device	English PDF
YY/T 1679-2021	Tissue-engineered Medical Device products Bone-In vivo guidelines for the preclinical evaluation of bone defects of critical size 组织工程医疗器械产品骨体内临界尺寸骨缺损的临床前评价指南	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1465.7—2021	Methods for evaluating the immunogenicity of Medical Devices Part 7: Flow-liquid-liquid multiplex protein quantification techniques 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 Device	English PDF
YY/T 0681.4—2021	Test methods for sterile Medical Device packaging - Part 4: Determination of seal leakage of breathable packaging by dye penetration method 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 Pharmaceutics Industry Standards Medical Device	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 Device	English PDF
YY/T 1733-2020	Radiation Sterilization of Medical Devices—Guidelines for Dose Distribution Testing of Irradiation Devices 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 Device	English PDF
YY/T 1759-2020	Guidelines for Design and Evaluation of Primary Flexible Packaging for Medical Devices 医疗器械软性初包装设计与评价指南	China Pharmaceutics Industry Standards Medical Device	English PDF
YY/T 1754.2-2020	Preclinical animal studies of Medical Devices Part 2: Rat skin defect model of induced diabetes 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 Device	English PDF

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