China Requirements medical devices Industry Standards English PDF List

China "Requirements medical devices" Industry Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements 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 Requirements medical devices	English PDF

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