Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1262—2015 |
Neuron-specific enolase quantitative labeling immunoassay kit{译} 神经元特异性烯醇化酶定量标记免疫分析试剂盒 |
China Pharmaceutics Industry Standards |
 English PDF |
| YY/T 1261—2015 |
HER2 Gene Detection Kit (fluorescent in situ hybridization){译} HER2基因检测试剂盒（荧光原位杂交法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1260—2015 |
Hepatitis E virus IgM antibody detection kit (enzyme-linked immunosorbent assay){译} 戊型肝炎病毒IgM抗体检测试剂盒（酶联免疫吸附法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1259—2015 |
Hepatitis E virus IgG antibody detection kit (enzyme-linked immunosorbent assay){译} 戊型肝炎病毒IgG抗体检测试剂盒（酶联免疫吸附法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1258—2015 |
Homocysteine detection reagent (box) (enzyme cycle method){译} 同型半胱氨酸检测试剂（盒)（酶循环法) |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1257—2015 |
Free human chorionic gonadotropin β subunit quantitative labeling immunoassay kit{译} 游离人绒毛膜促性腺激素β亚单位定量标记免疫分析试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1256—2015 |
Ureaplasma urealyticum nucleic acid amplification detection kit{译} 解脲脲原体核酸扩增检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1255—2015 |
Immunoturbidimetric detection reagent (box) (transmission method){译} 免疫比浊法检测试剂（盒)（透射法) |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1254—2015 |
High Density Lipoprotein Cholesterol Determination Reagent (Box){译} 高密度脂蛋白胆固醇测定试剂（盒） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1253—2015 |
Low Density Lipoprotein Cholesterol Determination Reagent (Box){译} 低密度脂蛋白胆固醇测定试剂（盒） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1252—2015 |
Total IgE Quantitative Labeled Immunoassay Kit{译} 总IgE定量标记免疫分析试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1095—2015 |
Myoelectric biofeedback instrument{译} 肌电生物反馈仪 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1040.1—2015 |
Anesthesia and respiratory equipment - Conical fittings - Part 1: Conical heads and sleeves{译} 麻醉和呼吸设备 圆锥接头 第1部分：锥头与锥套 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0998—2015 |
Semiconductor heating and cooling treatment equipment{译} 半导体升降温治疗设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0997—2015 |
Elbow and knee passive motion equipment{译} 肘、膝关节被动运动设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0996—2015 |
Urine Formed Components Analyzer (Digital Imaging Automatic Identification){译} 尿液有形成分分析仪（数字成像自动识别） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0995—2015 |
Medical devices for human assisted reproductive technology Terms and definitions{译} 人类辅助生殖技术用医疗器械 术语和定义 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0994—2015 |
magnetic stimulation device{译} 磁刺激设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0993—2015 |
Biological Evaluation of Medical Devices Nanomaterials: In Vitro Cytotoxicity Tests (MTT Test and LDH Test){译} 医疗器械生物学评价 纳米材料：体外细胞毒性试验（MTT试验和LDH试验） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0991—2015 |
Guidelines for Clinical Trials of Orthodontic Brackets{译} 正畸托槽临床试验指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0990—2015 |
Guidelines for clinical trials of polymer-based dental restoration materials{译} 聚合物基牙体修复材料临床试验指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0954—2015 |
Passive Surgical Implants - Type I Collagen Implants{译} 无源外科植入物-I型胶原蛋白植入剂 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0951—2015 |
interference with electrotherapy equipment{译} 干扰电治疗设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0950—2015 |
Pneumatic Ballistic Extracorporeal Pressure Wave Therapy Equipment{译} 气压弹道式体外压力波治疗设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0921—2015 |
Medical Absorbent Viscose Fiber{译} 医用吸水性粘胶纤维 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0915—2015 |
Dentistry Orthodontic brackets and buccal tubes{译} 牙科学 正畸用托槽和颊面管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0914—2015 |
Dentistry Laser Welding{译} 牙科学 激光焊接 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0913—2015 |
dental mandrel for rotary instruments{译} 牙科 旋转器械用心轴 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0912—2015 |
Dentistry Brazing materials{译} 牙科学 钎焊材料 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0879.2—2015 |
Medical device sensitization test Part 2: Mouse local lymph node assay (LLNA) BrdU-ELISA method{译} 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 |
English PDF |
| YY/T 0878.2—2015 |
Complement Activation Assay for Medical Devices Part 2: Serum Alternative Pathway Complement Activation{译} 医疗器械补体激活试验 第2部分：血清旁路途径补体激活 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0873.6—2015 |
Dentistry - Numerical coding systems for rotary instruments - Part 6: Characteristics of abrasive instruments{译} 牙科学 旋转器械的数字编码系统 第6部分：研磨器械的特征 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0803.4—2015 |
Dentistry - Endodontic instruments - Part 4: Auxiliary instruments{译} 牙科学 根管器械 第4部分：辅助器械 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0771.4—2015 |
Medical devices of animal origin - Part 4: Principles for the removal and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and their process validation analysis{译} 动物源医疗器械 第4部分：传播性海绵状脑病（TSE)因子的去除和/或灭活及其过程确认分析的原则 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0583.1—2015 |
Disposable chest drainage devices - Part 1: Water-sealed{译} 一次性使用胸腔引流装置 第1部分：水封式 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0466.2—2015 |
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 2: Development, selection and validation of symbols{译} 医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分：符号的制订、选择和确认 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0330—2015 |
Medical Absorbent Cotton{译} 医用脱脂棉 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0328—2015 |
Disposable arteriovenous trocar{译} 一次性使用动静脉穿刺器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0310—2015 |
General technical requirements for X-ray computed tomography equipment{译} X射线计算机体层摄影设备通用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0308—2015 |
Medical Sodium Hyaluronate Gel{译} 医用透明质酸钠凝胶 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0113—2015 |
Dentistry - Test method for wear resistance of composite resins{译} 牙科学 复合树脂耐磨耗性能测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0107—2015 |
Ophthalmology Type A Ultrasonic Measuring Instrument{译} 眼科A型超声测量仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0066—2015 |
Ophthalmic Instruments Glossary{译} 眼科仪器 名词术语 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0948—2015 |
Disposable arteriovenous cannula for cardiopulmonary bypass{译} 心肺转流系统一次性使用动静脉插管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0832.2—2015 |
Stereotactic and planning system for X-radiation radiotherapy Part 2: Stereotactic and planning system for body X-radiation radiotherapy{译} X辐射放射治疗立体定向及计划系统 第2部分：体部X辐射放射治疗立体定向及计划系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0831.2—2015 |
Gamma Beam Stereotactic Radiotherapy System Part 2: Body Multisource Gamma Beam Stereotactic Radiotherapy System{译} γ射束立体定向放射治疗系统 第2部分：体部多源γ射束立体定向放射治疗系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0605.9—2015 |
Surgical implants - Metallic materials - Part 9: Wrought high nitrogen stainless steel{译} 外科植入物 金属材料 第9部分：锻造高氮不锈钢 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0603—2015 |
Cardiovascular Implants and Prosthetics Cardiac Surgical Hard Cases Reservoir/Vinous Reservoir Systems (with or without Filters) and Venous Reservoir Bags{译} 心血管植入物及人工器官 心脏手术硬壳 贮血器/静脉贮血器系统（带或不带过滤器）和静脉贮血软袋 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0599—2015 |
Laser Therapy Equipment Excimer Laser Corneal Refractive Therapy Machine{译} 激光治疗设备 准分子激光角膜屈光治疗机 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0598—2015 |
Concentrates for hemodialysis and related treatments{译} 血液透析及相关治疗用浓缩物 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0572—2015 |
Hemodialysis and related treatment water{译} 血液透析及相关治疗用水 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1883-2023 |
Rh blood group C, c, E, e antigen test card (column agglutination method){译} Rh血型C、c、E、e抗原检测卡（柱凝集法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1882-2023 |
Treponema pallidum antibody detection kit (luminescent immunoassay){译} 梅毒螺旋体抗体检测试剂盒（发光免疫分析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1874-2023 |
Active Implantable Medical Devices - Electromagnetic Compatibility - Electromagnetic Compatibility Test Rules for Implantable Cardiac Pacemakers, Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Devices{译} 有源植入式医疗器械 电磁兼容 植入式心脏起搏器、植入式心律转复除颤器和心脏再同步器械的电磁兼容测试细则 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1866-2023 |
Disposable sterile anorectal ligation rubber ring or elastic thread type{译} 一次性使用无菌肛肠套扎器 胶圈或弹力线式 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1856-2023 |
General requirements for the safety of warmers for blood, venous medicine and lavage fluid{译} 血液、静脉药液、灌洗液加温器安全通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1789.5-2023 |
In vitro diagnostic test systems - Performance evaluation methods - Part 5: Analytical specificity{译} 体外诊断检验系统 性能评价方法 第5部分：分析特异性 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1411-2023 |
Dentistry-Test method for treatment of biofilm in waterways of dental units{译} 牙科学 牙科治疗机水路生物膜处理的试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1268-2023 |
Product Addition and Process Equivalence for Ethylene Oxide Sterilization{译} 环氧乙烷灭菌的产品追加和过程等效 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0893-2023 |
Medical Gas Mixer Standalone Gas Mixer{译} 医用气体混合器 独立气体混合器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0862-2023 |
Ophthalmic Optics Intraocular Fillers{译} 眼科光学 眼内填充物 |
China Pharmaceutics Industry Standards |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
English PDF |
| YY 0499-2023 |
Anesthesia and Respiratory Equipment Laryngoscopes for Endotracheal Intubation{译} 麻醉和呼吸设备 气管插管用喉镜 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1719-2023 |
General technical requirements for positron emission tomography and magnetic resonance imaging equipment{译} 正电子发射断层成像及磁共振成像设备通用技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1106-2023 |
electric operating table{译} 电动手术台 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1886-2023 |
Dentistry Amalgam in Capsules{译} 牙科学 胶囊装银汞合金 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1878-2023 |
Digital technical requirements for positron emission tomography devices{译} 正电子发射断层成像装置数字化技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1876-2023 |
Tissue-engineered medical products-Determination of DNA residues in biological materials of animal origin: fluorescent staining{译} 组织工程医疗产品 动物源性生物材料DNA残留量测定法：荧光染色法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1871-2023 |
medical isolation gown{译} 医用隔离衣 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1870-2023 |
General requirements for liquid chromatography-mass spectrometry kits{译} 液相色谱-质谱法测定试剂盒通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1869-2023 |
Detector array dosimetry system performance and test methods{译} 探测器阵列剂量测量系统 性能和试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1868-2023 |
Hepatitis B virus core antibody detection kit (luminescence immunoassay){译} 乙型肝炎病毒核心抗体检测试剂盒（发光免疫分析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1867-2023 |
Sports Medicine Implants Wired Anchor{译} 运动医学植入器械 带线锚钉 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1863-2023 |
Biological evaluation of nanomedical devices Release and characterization of nanosilver particles and silver ions from nanosilver-containing dressings{译} 纳米医疗器械生物学评价 含纳米银敷料中纳米银颗粒和银离子的释放与表征方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1862-2023 |
Special technical requirements for coronary artery CT image processing software{译} 冠状动脉CT影像处理软件专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1861-2023 |
Special technical requirements for medical image storage and transmission system software{译} 医学影像存储与传输系统软件专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1850-2023 |
Male condoms - Technical requirements and test methods for polyurethane condoms{译} 男用避孕套 聚氨酯避孕套的技术要求与试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1842.7-2023 |
Medical devices - Connections for medical reservoir delivery systems - Part 7: Connections for intravascular infusion{译} 医疗器械 医用贮液容器输送系统用连接件 第7部分：血管内输液用连接件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1789.6-2023 |
In vitro diagnostic test systems - Performance evaluation methods - Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents{译} 体外诊断检验系统 性能评价方法 第6部分：定性试剂的精密度、诊断灵敏度和特异性 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1473-2023 |
Guidelines for Standardization of Medical Devices Standardization Involving Safety Content{译} 医疗器械标准化工作指南 涉及安全内容的标准制定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1240-2023 |
D-dimer assay kit (immunoturbidimetric method){译} D-二聚体测定试剂盒(免疫比浊法) |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1199-2023 |
Triglyceride Determination Kit (Enzymatic Method){译} 甘油三酯测定试剂盒（酶法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0870.7-2023 |
Genotoxicity Tests for Medical Devices - Part 7: Alkaline Comet Test in Mammals{译} 医疗器械遗传毒性试验 第7部分：哺乳动物体内碱性彗星试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0730-2023 |
Cardiovascular surgical implants and artificial organs - Requirements for single-use tubing sets for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO){译} 心血管外科植入物和人工器官 心肺旁路和体外膜肺氧合（ECMO）使用的一次性使用管道套包的要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0720-2023 |
Single-use product packaging General requirements{译} 一次性使用产包 通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0606.15-2023 |
Tissue-engineered medical products-Test method for evaluating the immune response of matrices and scaffolds: Lymphocyte proliferation assay{译} 组织工程医疗产品 评价基质及支架免疫反应的试验方法：淋巴细胞增殖试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0506.1-2023 |
Medical surgical drapes, surgical gowns and clean clothes - Part 1: General requirements{译} 医用手术单、手术衣和洁净服 第1部分：通用要求 |
China Pharmaceutics Industry Standards |
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 |
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 |
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 |
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 |
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