China Medical Device GB Standards English PDF List

GB standards are the China national standards; Prefix code GB are Mandatory standards, GB/T are Recommended standards; All products or service must be compliance with GB standards; If you want to export products or services to huge Chinese market, need ensure they are meet the requirements of GB china national standards; We provide Chinese GB standards and English version GB standards Lookup, Translate, Download, Imported Commodity GB standards Testing and Compliance review services.

China "Medical Device" GB Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
YY 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
GB/T 16886.19-2022	Biological evaluation of Medical Devices - Part 19: Physicochemical, morphological and surface characterization of materials 医疗器械生物学评价第19部分：材料物理化学、形态学和表面特性表征	China National Standards Medical Device	English PDF
GB/Z 42217-2022	Medical Devices for the validation of medical device quality system software 医疗器械用于医疗器械质量体系软件的确认	China National Standards Medical Device	English PDF
GB/T 16886.9-2022	Biological evaluation of Medical Devices - Part 9: Qualitative and quantitative framework for potential degradation products 医疗器械生物学评价第9部分：潜在降解产物的定性和定量框架	China National Standards Medical Device	English PDF
GB/T 16886.15-2022	Biological Evaluation of Medical Devices-Part 15: Qualitative and Quantitative Degradation Products of Metals and Alloys 医疗器械生物学评价第15部分：金属与合金降解产物的定性与定量	China National Standards Medical Device	English PDF
GB/T 16886.18-2022	Biological evaluation of Medical Devices - Part 18: Chemical characterization of medical device materials in the risk management process 医疗器械生物学评价第18部分：风险管理过程中医疗器械材料的化学表征	China National Standards Medical Device	English PDF
GB/Z 16886.22-2022	Biological Evaluation of Medical Devices Part 22: Guidelines for Nanomaterials 医疗器械生物学评价第22部分：纳米材料指南	China National 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 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
GB/T 42218-2022	Laboratory medicine - In vitro diagnostic Medical Devices - Manufacturer's confirmation of quality control procedures provided to users 检验医学体外诊断医疗器械制造商对提供给用户的质量控制程序的确认	China National 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
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 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 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 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
GB/T 16886.1-2022	Biological evaluation of Medical Devices Part 1: evaluation and testing in the process of risk management 医疗器械生物学评价第1部分：风险管理过程中的评价与试验	China National Standards Medical Device	English PDF
GB/T 16886.6-2022	Biological evaluation of Medical Devices Part 6: local response test after implantation 医疗器械生物学评价第6部分：植入后局部反应试验	China National Standards Medical Device	English PDF
GB/T 16886.4-2022	Biological evaluation of Medical Devices - Part 4: selection of interaction test with blood 医疗器械生物学评价第4部分：与血液相互作用试验选择	China National Standards Medical Device	English PDF
GB/T 42062-2022	Medical Devices Application of Risk Management to Medical Devices 医疗器械风险管理对医疗器械的应用	China National Standards Medical Device	English PDF
GB/T 42061-2022	Medical Device quality management system for regulatory requirements 医疗器械质量管理体系用于法规的要求	China National 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 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 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/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
GB/T 19702-2021	In vitro diagnostic Medical Devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures 体外诊断医疗器械生物源性样品中量的测量参考测量程序的表述和内容的要求	China National 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 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 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 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 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
GB/T 16886.16-2021	Biological evaluation of Medical Devices—Part 16: Toxicokinetic study design for degradation products and leachables 医疗器械生物学评价第16部分：降解产物与可沥滤物毒代动力学研究设计	China National Standards Medical Device	English PDF
GB/T 16886.11-2021	Biological evaluation of Medical Devices—Part 11:Tests for systemic toxicity 医疗器械生物学评价第11部分：全身毒性试验	China National 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
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
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 5473.3-2022	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
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 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 1754.1-2020	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 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
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 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 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 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 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 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
GB/T 19703-2020	In vitro diagnostic Medical Devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation 体外诊断医疗器械生物源性样品中量的测量有证参考物质及支持文件内容的要求	China National 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 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 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
GB/T 16886.3-2019	Biological evaluation of Medical Devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 医疗器械生物学评价第3部分：遗传毒性、致癌性和生殖毒性试验	China National 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 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 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 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 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 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 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 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 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 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 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 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 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
GB/T 19974-2018	Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for Medical Devices 医疗保健产品灭菌灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求	China National Standards Medical Device	English PDF
GB/T 19973.2-2018	Sterilization of Medical Devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process 医疗器械的灭菌微生物学方法第2部分：用于灭菌过程的定义、确认和维护的无菌试验	China National Standards Medical Device	English PDF
GB 18280.1-2015	Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for Medical Devices 医疗保健产品灭菌辐射第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 16174.2-2015	Implants for surgery—Active implantable Medical Devices—Part 2: Cardiac 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 16174.1-2015	Implants for surgery—Active implantable Medical Devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer 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/T 16886.6-2015	Biological evaluation of Medical Devices—Part 6: Tests for local effects after implantation 医疗器械生物学评价第6部分：植入后局部反应试验	China National 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
GB/T 18457-2015	Stainless steel needle tubing for the manufacture of Medical Devices 制造医疗器械用不锈钢针管	China National Standards Medical Device	English PDF
GB/T 16886.7-2015	Biological evaluation of Medical Devices—Part 7: Ethylene oxide sterilization residuals 医疗器械生物学评价第7部分：环氧乙烷灭菌残留量	China National Standards Medical Device	English PDF
GB/T 16886.20-2015	Biological evaluation of Medical Devices—Part 20: Principles and methods for immunotoxicology testing of medical devices 医疗器械生物学评价第20部分：医疗器械免疫毒理学试验原则和方法	China National Standards Medical Device	English PDF
GB 18279.1-2015	Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for Medical Devices 医疗保健产品灭菌环氧乙烷第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求	China National Standards Medical Device	English PDF
GB 18278.1-2015	Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for Medical Devices 医疗保健产品灭菌湿热第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
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 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 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 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 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

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