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Keyword:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1928—2023 |
Terminology and classification of medical electrical equipment intended for use in magnetic resonance environments {译} 预期用于磁共振环境的医用电气设备的术语和分类 |
China Pharmaceutics Industry
Standards Medical equipment |
 English PDF |
| JB/T 14576-2023 |
Rolling bearings Main bearings for medical X-ray computed tomography equipment (CT machine) {译} 滚动轴承 医用X射线计算机体层摄影设备（CT机）主轴承 |
China Machinery Industry
Standards Medical equipment |
English PDF |
| HB 8659-2022 |
Specification for onboard medical oxygen supply equipment for civil aircraft {译} 民用飞机机载医疗供氧设备规范 |
China Aviation Industry
Standards Medical equipment |
English PDF |
| YY/T 0841—2023 |
Medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment {译} 医用电气设备 医用电气设备周期性测试和修理后测试 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 0601-2009 |
Medical electrical equipment - Particular requirements for basic safety and main performance of respiratory gas monitors {译} 医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0841-2011 |
Medical electrical equipment Periodic testing and post-repair testing of medical electrical equipment {译} 医用电气设备 医用电气设备周期性测试和修理后测试 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0770.2-2009 |
Filter materials for medical infusion and injection equipment - Part 2: Air filter materials {译} 医用输液、注器具用过滤材料 第2部分：空气过滤材料 |
China Pharmaceutics Industry
Standards Medical equipment |
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 equipment |
English PDF |
| YY/T 0840-2011 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance {译} 医用电气设备 放射性核素校准仪 描述性能的专用方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1894-2023 |
Verification method for reliability index of medical magnetic resonance equipment {译} 医用磁共振设备可靠性指标验证方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 0505—2012 |
Medical electrical equipment - Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility requirements and tests {译} 医用电气设备 第1-2部分：安全通用要求 并列标准：电磁兼容 要求和试验 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 0945.2-2015 |
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with an internal power supply {译} 医用电气设备 第2部分：带内部电源的体外心脏起搏器安全专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1278—2015 |
Measurement method of sound beam area of transducer of medical ultrasonic equipment {译} 医用超声设备换能器声束面积测量方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1084—2015 |
Measurement method of acoustic output power of medical ultrasonic diagnostic equipment {译} 医用超声诊断设备声输出功率的测量方法 |
China Pharmaceutics Industry
Standards Medical equipment |
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 equipment |
English PDF |
| YY 9706.284-2023 |
Medical electrical equipment - Part 2-84: Particular requirements for basic safety and essential performance of ventilators for use in emergency medical service environments {译} 医用电气设备 第2-84部分：紧急医疗服务环境用呼吸机的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.280-2023 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of respiratory support equipment for respiratory insufficiency {译} 医用电气设备 第2-80部分：用于呼吸功能不全的呼吸支持设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.279-2023 |
Medical Electrical Equipment Part 2-79: Particular Requirements for Basic Safety and Essential Performance of Respiratory Support Equipment for Respiratory Impairments {译} 医用电气设备 第2-79部分：用于呼吸功能障碍的呼吸支持设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.278-2023 |
Medical electrical equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or mitigation {译} 医用电气设备 第2-78部分：康复、评定、代偿或缓解用医用机器人的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.256-2023 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for temperature measurement {译} 医用电气设备 第2-56部分：用于体温测量的临床体温计的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.231-2023 |
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power supply {译} 医用电气设备 第2-31部分：带内部电源的体外心脏起搏器的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| WS 816—2023 |
Quality control testing standard for medical proton heavy ion radiotherapy equipment {译} 医用质子重离子放射治疗设备质量控制检测标准 |
China Hygiene Industry
Standards Medical equipment |
English PDF |
| YY/T 1840-2023 |
General technical requirements for medical magnetic resonance imaging equipment {译} 医用磁共振成像设备通用技术条件 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.277-2023 |
Medical electrical equipment - Part 2-77: Particular requirements for basic safety and essential performance of robotically assisted surgical equipment {译} 医用电气设备 第2-77部分：采用机器人技术的辅助手术设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.261-2023 |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximetry equipment {译} 医用电气设备 第2-61部分:脉搏血氧设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.249-2023 |
Medical electrical equipment - Part 2-49: Particular requirements for basic safety and essential performance of multiparameter patient monitors {译} 医用电气设备 第2-49部分:多参数患者监护仪的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.246-2023 |
Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables {译} 医用电气设备 第2-46部分: 手术台的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.230-2023 |
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automatic non-invasive sphygmomanometers {译} 医用电气设备 第2-30部分:自动无创血压计的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1858-2022 |
Artificial intelligence Medical equipment, lung image auxiliary analysis software, algorithm performance testing method {译} 人工智能医疗器械 肺部影像辅助分析软件 算法性能测试方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0482-2022 |
Medical magnetic resonance imaging equipment - Determination of main image quality parameters {译} 医用磁共振成像设备 主要图像质量参数的测定 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.268-2022 |
Medical electrical equipment - Part 2-68: Particular requirements for basic safety and essential performance of X-ray image-guided radiotherapy equipment for electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment {译} 医用电气设备 第2-68部分：电子加速器、轻离子束治疗设备和放射性核素射束治疗设备用的X射线图像引导放射治疗设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.264-2022 |
Medical electrical equipment - Part 2-64: Particular requirements for basic safety and essential performance of light ion beam medical electrical equipment {译} 医用电气设备 第2-64部分：轻离子束医用电气设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.258-2022 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens extraction and vitrectomy equipment for ophthalmic surgery {译} 医用电气设备 第2-58部分：眼科手术用晶状体摘除及玻璃体切除设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1843-2022 |
Basic requirements for network security of medical electrical equipment {译} 医用电气设备网络安全基本要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1837-2022 |
General requirements for reliability of medical electrical equipment {译} 医用电气设备 可靠性通用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1827.1-2022 |
Medical electrical equipment - Radiation dose documentation - Part 1: Structured report on radiation dose for photographic and fluoroscopy equipment {译} 医用电气设备 辐射剂量文件 第1部分:摄影和透视设备辐射剂量结构化报告 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1813-2022 |
Method for collecting and evaluating medical electrical equipment service reliability information {译} 医用电气设备使用可靠性信息收集与评估方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| WS/T 793-2022 |
Medical equipment Equipping Standards for Maternal and Child Health Care Institutions{译} {译} 妇幼保健机构医用设备配备标准 |
China Hygiene Industry
Standards Medical equipment |
English PDF |
| YY 9706.274-2022 |
Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidification equipment{译} {译} 医用电气设备 第2-74部分：呼吸湿化设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.272-2021 |
Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of domestic ventilators used by ventilator-dependent patients {译} 医用电气设备 第2-72部分：依赖呼吸机患者使用的家用呼吸机的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.270-2021 |
Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea therapy equipment {译} 医用电气设备 第2-70部分：睡眠呼吸暂停治疗设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.252-2021 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds {译} 医用电气设备 第2-52部分:医用病床的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.247-2021 |
Medical electrical equipment Part 2-47: Particular requirements for basic safety and essential performance of Holter monitoring systems {译} 医用电气设备 第2-47部分：动态心电图系统的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.234-2021 |
Medical electrical equipment - Part 2-34: Particular requirements for basic safety and essential performance of invasive blood pressure monitoring equipment {译} 医用电气设备 第2-34部分:有创血压监护设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.221-2021 |
Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of radiant warmers for infants {译} 医用电气设备 第2-21部分：婴儿辐射保暖台的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1708.6-2021 |
Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment - Part 6: Oral X-ray machines {译} 医用诊断X射线影像设备连通性符合性基本要求 第6部分：口腔X射线机 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1708.5-2021 |
Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment Part 5: Mammography machine {译} 医用诊断X射线影像设备连通性符合性基本要求 第5部分：乳腺X射线机 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1708.4-2021 |
Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment - Part 4: Digital subtraction angiography X-ray machine {译} 医用诊断X射线影像设备连通性符合性基本要求 第4部分：数字减影血管造影X射线机 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1708.3-2021 |
Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment - Part 3: Digital photographic X-ray machines {译} 医用诊断X射线影像设备连通性符合性基本要求 第3部分：数字化摄影X射线机 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0910.1-2021 |
Medical electrical equipment - Medical image display system - Part 1: Evaluation method {译} 医用电气设备 医学影像显示系统 第1部分：评价方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.269-2021 |
Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrators {译} 医用电气设备 第2-69部分：氧气浓缩器的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.262-2021 |
Medical electrical equipment Part 2-62: Particular requirements for basic safety and essential performance of high-intensity ultrasound therapy (HITU) equipment {译} 医用电气设备 第2-62部分：高强度超声治疗（HITU）设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.257-2021 |
Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment for therapeutic, diagnostic, monitoring and plastic/medical cosmetic use {译} 医用电气设备 第2-57部分：治疗、诊断、监测和整形/医疗美容使用的非激光光源设备基本安全和基本性能的专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.250-2021 |
Medical electrical equipment - Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment {译} 医用电气设备 第2-50部分:婴儿光治疗设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.240-2021 |
Medical electrical equipment - Part 2-40: Particular requirements for basic safety and basic performance of electromyography and evoked response equipment {译} 医用电气设备 第2-40部分：肌电及诱发反应设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.235-2021 |
Medical electrical equipment - Part 2-35: Particular requirements for basic safety and essential performance of medical blanket, pad or mattress heating equipment {译} 医用电气设备 第2-35部分：医用毯、垫或床垫式加热设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.233-2021 |
Medical electrical equipment - Part 2-33: Particular requirements for basic safety and essential performance of magnetic resonance equipment for medical diagnostic use {译} 医用电气设备 第2-33部分：医疗诊断用磁共振设备的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.220-2021 |
Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of infant transport incubators {译} 医用电气设备 第2-20部分:婴儿转运培养箱的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.210-2021 |
Medical electrical equipment - Part 2-10: Particular requirements for basic safety and essential performance of nerve and muscle stimulators {译} 医用电气设备 第2-10部分：神经和肌肉刺激器的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.112-2021 |
Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services enviro {译} 医用电气设备 第1-12部分：基本安全和基本性能的通用要求 并列标准：预期在紧急医疗服务环境中使用的医用电气设备和医用电气系统的要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.111-2021 |
Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems for Use in Home Care Environments {译} 医用电气设备 第1-11部分：基本安全和基本性能的通用要求 并列标准：在家庭护理环境中使用的医用电气设备和医用电气系统的要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 9706.110-2021 |
Medical Electrical Equipment Part 1-10: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for the Development of Physiological Closed-Loop Controllers {译} 医用电气设备 第1-10部分：基本安全和基本性能的通用要求 并列标准：生理闭环控制器开发要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.108-2021 |
Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Essential Performance Collateral Standard: General Requirements, Tests and Guidelines for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems {译} 医用电气设备 第1-8部分：基本安全和基本性能的通用要求 并列标准：通用要求,医用电气设备和医用电气系统中报警系统的测试和指南 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 9706.106-2021 |
Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Availability {译} 医用电气设备 第1-6部分：基本安全和基本性能的通用要求 并列标准：可用性 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.102-2021 |
Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility Requirements and Tests {译} 医用电气设备 第1-2部分：基本安全和基本性能的通用要求 并列标准：电磁兼容 要求和试验 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0636.3—2021 |
Medical suction equipment part 3: suction equipment powered by a vacuum or positive pressure source {译} 医用吸引设备 第3部分：以真空或正压源为动力的吸引设备 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0636.1—2021 |
Medical suction equipment Part 1: Electric suction equipment {译} 医用吸引设备 第1部分：电动吸引设备 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0746—2021 |
Special technical conditions for on-board medical X-ray diagnostic equipment {译} 车载医用X射线诊断设备专用技术条件 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0636.2—2021 |
Medical suction equipment Part 2: Manually actuated suction equipment {译} 医用吸引设备 第2部分：人工驱动吸引设备 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1763-2021 |
Medical electrical equipment Medical light ion beam equipment Performance characteristics {译} 医用电气设备 医用轻离子束设备 性能特性 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 9706.241- 2020 |
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical shadowless and diagnostic lamps {译} 医用电气设备 第2-41部分：手术无影灯和诊断用照明灯的基本安全和基本性能专用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1738-2020 |
Method for measuring energy consumption of medical electrical equipment {译} 医用电气设备能耗测量方法 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1708.2-2020 |
Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment - Part 2: X-ray computed tomography equipment {译} 医用诊断X射线影像设备连通性符合性基本要求 第2部分：X射线计算机体层摄影设备 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY 0899—2020 |
General requirements for accessories for medical microwave equipment {译} 医用微波设备附件的通用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1708.1-2020 |
Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment - Part 1: General requirements {译} 医用诊断X射线影像设备连通性符合性基本要求 第1部分：通用要求 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 1686-2020 |
Medical electrical equipment using robotics {译} 采用机器人技术的医用电气设备 分类 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| WS 76-2020 |
Specification for quality control and testing of medical X-ray diagnostic equipment {译} 医用X射线诊断设备质量控制检测规范 |
China Hygiene Industry
Standards Medical equipment |
English PDF |
| YY/T 1628—2019 |
Polyvinyl chloride pellets for medical infusion and blood transfusion equipment {译} 医用输液、输血器具用聚氯乙烯粒料 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| YY/T 0976-2016 |
(Medical electrical equipment - radiotherapy ionization chamber dosimeter) 医用电气设备放射治疗用电离室剂量计 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0481-2016 |
(Medical Diagnostic X-ray equipment with radiation characteristic measurement conditions) 医用诊断x射线设备测定特性用辐射条件 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0291-2016 |
(Medical X-ray equipment environmental requirements and test methods) 医用x射线设备环境要求及试验方法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1473-2016 |
(Standards of Medical equipment standardization guide covers safety requirements) 医疗器械标准化工作指南涉及安全要求的标准制定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1427-2016 |
(Surgical implants implantable test solution and material conditions and Medical equipment static and dynamic corrosion tests) 外科植入物可植入材料及医疗器械静态和动态腐蚀试验的测试溶液和条件 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1420-2016 |
(Medical ultrasound equipment environmental requirements and test methods) 医用超声设备环境要求及试验方法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0734.4-2016 |
(Cleaning and disinfection - Part 4: Non-intrusive and other Medical equipment for heat disinfection cleaning and disinfection - Requirements and test) 清洗消毒器 第4部分：对非介入式等医疗器械进行湿热消毒的清洗消毒器要求和试验 |
China Medicine & Medical Device
Standards Medical equipment |
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 equipment |
English PDF |
| YY 0945.2-2015 |
Medical electrical equipment. Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source 医用电气设备 第2部分：带内部电源的体外心脏起搏器安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1278-2015 |
Measuring methods for beam area of medical ultrasound equipment transducer 医用超声设备换能器声束面积测量方法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1084-2015 |
Measurement methods of ultrasonic output power for medical diagnostic ultrasonic equipments 医用超声诊断设备声输出功率的测量方法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0955-2014 |
Medical endoscopes. Endoscope surgical equipment. Shaver 医用内窥镜 内窥镜手术设备 刨削器 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0929.1-2014 |
Sterilizing-grade filters for medical infusion equipments. Part 1:Integrity test for fluid filters. 输液用除菌级过滤器 第1部分:药液过滤器完整性试验 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0955-2014 |
Medical endoscope Endoscopic surgical equipment Planer{译} {译} 医用内窥镜 内窥镜手术设备 刨削器 |
China Pharmaceutics Industry
Standards Medical equipment |
English PDF |
| SN/T 1672.8-2013 |
Rules for the inspection of import and export Medical equipment. Part 8: Ultrasonic diagnostic and physiotherapy equipment 进出口医用设备检验规程 第8部分:超声诊断和理疗设备 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| SN/T 1672.7-2013 |
Rules for the inspection of Medical equipment for import and export. Part 7: Medical endoscope 进出口医用设备检验规程 第7部分:医用内窥镜 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| YY/T 1142-2013 |
Methods of measuring the frequency of medical ultrasonic equipment and probe 医用超声设备与探头频率特性的测试方法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0910.1-2013 |
Medical electrical equipment. Medical image display systems. Part 1: Evaluation methods 医用电气设备医用影像显示系统 第1部分：评价方法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0894-2013 |
Medical electrical equipment. Dosimetric instruments as used in brachtherapy. Instruments based on well-type ionization chambers 医用电气设备近距离放射治疗用剂量仪器基于井型电离室的仪器 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0899-2013 |
General requirements for accessories of microwave equipment in medical parctices 医用微波设备附件的通用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0896-2013 |
Medical electrical equipment. Part 2: Particular requiremetns for the safety of electromyograohs and evoked response equipment 医用电气设备 第2部分：肌电及诱发反应设备安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0885-2013 |
Medical electrical equipment-Part 2: Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems 医用电气设备 第2部分：动态心电图系统安全和基本性能专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0637-2013 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems 医用电气设备 放射治疗计划系统的安全要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0571-2013 |
Medical electrical equipment. Part 2: Particular requirements for the safety of electrically operated hospital beds 医用电气设备 第2部分：医院电动床安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0570-2013 |
Medical electrical equipment. Part 2: Particular requirements for the safety of operating tables 医用电气设备 第2部分：手术台安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| SN/T 1672.6-2013 |
Rules for the inspection of import and export Medical equipment. Part 6: Magnetic resonance imaging equipment for medical diagnosis 进出口医用设备检验规程 第x部分：医疗诊断用磁共振设备 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| SN/T 1672.1-2013 |
Rules for the inspection of import and export Medical equipment. Part 1: General requirements 进出口医用设备检验规程 第1部分：通用要求 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| YY 0505-2012 |
Medical electrical equipment. Part 1-2:General requirements for safety. Collateral standard:Electromagnetic compatibility. Requirements and tests 医用电气设备 第1-2部分：安全通用要求并列标准：电磁兼容 要求和试验 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0863-2011 |
Medical endoscopes. Endoscope functional supply units. Roller irrigation and suction equipment 医用内窥镜 内窥镜功能供给装置 滚压式冲洗吸引器 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0841-2011 |
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment 医用电气设备 医用电气设备周期性测试和修理后测试 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0840-2011 |
Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance 医用电气设备 放射性核素校准仪 描述性能的专用方法 |
China Medicine & Medical Device
Standards Medical equipment |
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 equipment |
English PDF |
| YY 0834-2011 |
Medical electrical equipment. Part 2-35:Particular requirements for the safety of blankets, pads and mattesses, intended for heating in medical use 医用电气设备 第二部分：医用电热毯、电热垫和电热床垫 安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0827-2011 |
Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators 医用电气设备 第2部分：转运培养箱安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0455-2011 |
Medical electrical equipment. Part 2: Particular requirements for the safety of infant radiant warmers 医用电气设备 第2部分：婴儿辐射保暖台安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
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 equipment |
English PDF |
| YY/T 0796.1-2010 |
Medical electrical equipment. Exposure index of digital X-ray imaging systems. Part 1: Definitions and requirements for general radiography 医用电气设备 数字x射线成像系统的曝光指数 第1部分：普通x射线摄影的定义和要求 |
China Medicine & Medical Device
Standards Medical equipment |
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 equipment |
English PDF |
| YY/T 0482-2010 |
Magnetic resonance equipment for medical imaging. Part 1: Determination of essential image quality parameters 医疗成像磁共振设备 主要图像质量参数的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0784-2010 |
Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use 医用电气设备——医用脉搏血氧仪设备基本安全和主要性能专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0783-2010 |
Medical electrical equipment. Part 2-34:Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipments 医用电气设备 第2-34部分：有创血压检测设备的安全和基本性能专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0782-2010 |
Medical electrical equipment. Part 2-51:Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs 医用电气设备 第2-51部分：记录和分析型单道和多道心电图机安全和基本性能专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0770.2-2009 |
Filter material for medical infusion equipments. Part 2: Air filter material 医用输、注器具用过滤材料 第2部分：空气过滤材料 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0770.1-2009 |
Fitter material for medical infusion equipments. Part 1: Fluid filter material 医用输、注器具用过滤材料 第1部分：药液过滤材料 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0601-2009 |
Medical electrical equipment. Particular requirements for basic safety and essential performance of respiratory gas monitors 医用电气设备 呼吸气体监护仪的基本安全和主要性能专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0709-2009 |
Medical electrical equipment. Part 1-8:General requirements for safety. Collateral standard:General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 医用电气设备 第1-8部分：安全通用要求 并列标准：通用要求 医用电气设备和医用电气系统中报警系统的测试和指南 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0740-2009 |
particular specification for medical X-ray angiography equipment 医用血管造影x射线机专用技术条件 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0739-2009 |
particular specification for wall stand of medical X-ray equipment 医用x射线立式摄影架专用技术条件 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0736-2009 |
Medical electrical equipment. Guidelines for implementation of DICOM in radiotherapy 医用电气设备 dicom在放射治疗中的应用指南 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0708-2009 |
Medical electrical equipment. Part 1-4:General requirements for safety. Collateral standard:Programmable electrical medical systems 医用电气设备 第1-4部分：安全通用要求：可编程医用电气系统 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0162.1-2009 |
Medical ultrasound equipment class series. Part 1: B mode ultrasound disgnostic equipment 医用超声设备档次系列 第1部分：b型超声诊断设备 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0723-2009 |
Medical electrical equipment. Digital imaging and communications in medicine (DICOM). Radiotherapy objects 医用电气设备 医学数字影像和通讯（dicom）-放射治疗对象 |
China Medicine & Medical Device
Standards Medical equipment |
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 equipment |
English PDF |
| YY 0721-2009 |
Medical electrical equipment-Safety of radiotherapy record and verify systems 医用电气设备 放射性治疗记录与验证系统的安全 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0669-2008 |
Medical electrical equipment. Part 2-50:Particular requirements for the safety of infant phototherapy equipment 医用电气设备 第2部分：婴儿光治疗设备安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0668-2008 |
Medical electrical equipment. Part 2-49:Particular requiremens for the safety of multifunction patient monitoring equipment 医用电气设备 第2部分：多参数患者监护设备安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0667-2008 |
Medical electrical equipment. Part 2-30:Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment 医用电气设备 第2部分:自动循环无创血压监护设备的安全和基本性能专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0114-2008 |
Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use 医用输液、输血、注射器具用聚乙烯专用料 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0106-2008 |
General specifications for medical diagnostic X-ray equipment 医用诊断x射线机通用技术条件 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0648-2008 |
Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101:Particular requirements for in vitro diagnostic (IVD) Medical equipment 测量、控制和实验室用电气设备的安全要求 第2-101部分：体外诊断（ivd）医用设备的专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0636.3-2008 |
Medical suction equipment. Part 3: Suction equipment powered from a vacuum or pressure source 医用吸引设备 第3部分：以负压或压力源为动力的吸引设备 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0636.2-2008 |
Medical suction equipment. Part 2: Manually powered suction equipment 医用吸引设备 第2部分：人工驱动吸引设备 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0636.1-2008 |
Medical suction equipment. Part 1: Electrically powered suction equipment. Safety requirements 医用吸引设备 第1部分：电动吸引设备 安全要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0627-2008 |
Medical electrical equipment. Part 2-41:Particular requirements for the safety of surgical luminaries and luminaries for diagnosis 医用电气设备 第2部分：手术无影灯和诊断用照明灯安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0319-2008 |
Medical Electrical Equipment. Part 2-33:Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis 医用电气设备 第2部分: 医疗诊断用磁共振设备安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| SN/T 0323.3-2007 |
Rules for the inspection of Medical equipment for import and export. Part 3: Plastics collapsible containers for human blood. Blood components conventional containers 进出口医疗器械检验规程 第3部分:人体血液及血液成分袋式塑料容器 传统型血袋 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| SN/T 0323.2-2007 |
Rules for the inspection of Medical equipment for import and export. Part 2: Sterile hypodermic syringes for single use 进出口医疗器械检验规程 第2部分:一次性使用无菌注射器 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| SN/T 0323.1-2007 |
Rules for the inspection of Medical equipment for import and export. Part 1: Infusion and transfusion sets for single use 进出口医疗器械检验规程 第1部分:一次性使用输液(血)器 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| YY/T 0242-2007 |
Polypropylene material for manufacture of infusion, transfusion and injection equipment for medical use 医用输液、输血、注射器具用聚丙烯专用料 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0607-2007 |
Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators 医用电气设备 第2部分：神经和肌肉刺激器安全专用要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY 0602-2007 |
Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 2-043:Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory process 测量、控制和试验室用电气设备的安全使用热空气或惰性气体处理医用材料及供试验室用的干热灭菌器的特殊要求 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1099-2007 |
Packaging, transportation and storage for medical X-ray equipment 医用x射线设备包装、运输和贮存 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 1088-2007 |
Guidance for the measurement and characterization of ultrasonic fields benerated by medical ultrasonic equipment using hydrophones in the frequency rang 0.5 MHz to 15 MHz 在0.5mhz至15mhz频率范围内采用水听器测量与表征医用超声设备声场特性的导则 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0317-2007 |
General specifications for medical therapeutic X-ray equipment 医用治疗x射线机通用技术条件 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0063-2007 |
Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Characteristics of focal spots 医用电气设备医用诊断x射线管组件 焦点特性 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| SN/T 1672.5-2006 |
Rules for the inspection of medical electrical equiment for import and export. Part 5: Medical diagnostic X-ray equipment 进出口医用设备检验规程 第5部分:医用诊断x射线机 |
China Import Export Inspection
Standards Medical equipment |
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 equipment |
English PDF |
| SN/T 1672.4-2005 |
Rules for the inspection of Medical equipment for import and export. Part 4: B mode ultrasonic diagnostic equipment 进出口医用设备检验规程 第4部分:b型超声诊断设备 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| SN/T 1672.3-2005 |
Rules for the inspection of Medical equipment for import and export. Part 3: Transcranial Doppler blood flow analyzer 进出口医用设备检验规程 第3部分:经颅多谱勒血分析仪 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| SN/T 1672.2-2005 |
Rules for the inspection of Medical equipment for import and export. Part 2: General spiral computed tomography scanner 进出口医用设备检验规程 第2部分:全身螺旋ct扫描仪 |
China Import Export Inspection
Standards Medical equipment |
English PDF |
| YY/T 0457.7-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 7: Determination of the modulation transfer function 医用电气设备 光电x射线影像增强器特性 第7部分：调制传递函数的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0457.6-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 6: Determination of the contrast ratio and veiling glare index 医用电气设备 光电x射线影像增强器特性 第6部分：对比度及炫光系数的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0457.5-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 5: Determination of the detective quantum efficiency 医用电气设备 光电x射线影像增强器特性 第5部分：探测量子效率的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0457.4-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 4: Determination of the image distortion 医用电气设备 光电x射线影像增强器特性 第4部分：影像失真的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0457.3-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 3: Determination of the luminance distribution and luminance non-uniformity 医用电气设备 光电x射线影像增强器特性 第3部分：亮度分布和非均匀性测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0457.2-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 2: Determination of the conversion factor 医用电气设备 光电x射线影像增强器特性 第2部分：转换系数的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 0457.1-2003 |
Medical electrical equipment. Characteristics of electro-optical X-ray image intensifiers. Part 1: Determination of the entrance field size 医用电气设备 光电x射线影像增强器特性 第1部分：入射野尺寸的测定 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| YY/T 91049-1999 |
Class Ⅲ expansion classification of standards documentation for medical instruments and equipment 医疗器械标准文献三级类目扩充分类法 |
China Medicine & Medical Device
Standards Medical equipment |
English PDF |
| JJG 639-1998 |
Verification regulation of ultrasonic source for medical ultrasonic diagnostic equipment 医用超声诊断仪超声源检定规程 |
China Metrological
Standards Medical equipment |
English PDF |
| SJ/T 11096-1996 |
Measuring methods for medical X-ray television equipments 医用ｘ射线电视设备测量方法 |
China Electronics
Standards Medical equipment |
English PDF |
| SJ/T 11095-1996 |
General specification for medical X-ray television equipment 医用ｘ射线电视设备通用技术条件 |
China Electronics
Standards Medical equipment |
English PDF |
| JJG 806-1993 |
V.R.of the Ultrasonic Souce of Ultrasonic Therapeutic Equipment for Medical Use 医用超声治疗机超声源 |
China Metrological
Standards Medical equipment |
English PDF |
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