Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| 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 |
 English PDF |
| YY 0777-2023 |
Radio frequency hyperthermia equipment{译} 射频热疗设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0054-2023 |
Hemodialysis equipment{译} 血液透析设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1853-2022 |
Ultrasonic Bone Tissue Surgery Equipment Knives{译} 超声骨组织手术设备刀具 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0642-2022 |
Ultrasound - Acoustic field characteristics - Test method for determining thermal and mechanical indices of medical diagnostic ultrasound fields{译} 超声 声场特性 确定医用诊断超声场热和机械指数的试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0567.6-2022 |
Aseptic processing of healthcare products - Part 6: Isolator systems{译} 医疗保健产品的无菌加工 第6部分：隔离器系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0493-2022 |
Dentistry Elastomeric impression materials{译} 牙科学 弹性体印模材料 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0321.3-2022 |
Disposable filter for anesthesia{译} 一次性使用麻醉用过滤器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1872-2022 |
Negative pressure drainage sponge{译} 负压引流海绵 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1864-2022 |
Human factor design requirements and evaluation methods for spinal internal fixation systems and surgical instruments{译} 脊柱内固定系统及手术器械的人因设计要求与测评方法 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1854-2022 |
Test method for dissolution of trioctyl trimellitate (TOTM) in polyvinyl chloride medical devices{译} 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 |
English PDF |
| YY/T 1852-2022 |
Medical devices for human assisted reproductive technology Determination of ammonium ions in culture solution{译} 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 |
English PDF |
| YY/T 1851-2022 |
Medically Pure Tantalum Powders for Additive Manufacturing{译} 用于增材制造的医用纯钽粉末 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1842.6-2022 |
Medical devices - Connections for medical reservoir delivery systems - Part 6: Neurological applications{译} 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 |
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 |
English PDF |
| YY/T 1829-2022 |
Dentistry - In vitro evaluation method of dentinal tubule occlusion effect{译} 牙科学 牙本质小管封堵效果体外评价方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0772.4-2022 |
Surgical implants - Ultra high molecular weight polyethylene - Part 4: Oxidation index test method{译} 外科植入物 超高分子量聚乙烯 第4部分：氧化指数测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0334-2022 |
General requirements for silicone rubber surgical implants{译} 硅橡胶外科植入物通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0325-2022 |
Disposable sterile urinary catheter{译} 一次性使用无菌导尿管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1879-2022 |
Creation and assignment of unique identifiers for medical devices{译} 医疗器械唯一标识的创建和赋予 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0793.1-2022 |
Preparation and quality control of fluids for hemodialysis and related treatments - Part 1: Water treatment equipment for hemodialysis and related treatments{译} 血液透析和相关治疗用液体的制备和质量管理 第1部分：血液透析和相关治疗用水处理设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0299-2022 |
Medical Ultrasonic Couplant{译} 医用超声耦合剂 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1835-2022 |
Performance and test method of mammary positron emission tomography device{译} 乳腺正电子发射断层成像装置性能和试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1789.4-2022 |
In vitro diagnostic test systems - Performance evaluation methods - Part 4: Linear and reportable intervals{译} 体外诊断检验系统 性能评价方法 第4部分：线性区间与可报告区间 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1789.3-2022 |
In vitro diagnostic test systems - Performance evaluation methods - Part 3: Limits of detection and limits of quantitation{译} 体外诊断检验系统 性能评价方法 第3部分：检出限与定量限 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0273-2022 |
Dentistry Dental amalgam sets{译} 牙科学 牙科银汞调合器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1848-2022 |
Disposable ureteral closure catheter{译} 一次性使用输尿管封堵导管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1845-2022 |
General requirements for surgical guides for orthopedic surgery{译} 矫形外科用手术导板通用要求 |
China Pharmaceutics Industry Standards |
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 |
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 |
English PDF |
| YY/T 1810-2022 |
Tissue-engineered medical products Quantitative detection of sulfated glycosaminoglycans (sGAG) for evaluation of cartilage formation{译} 组织工程医疗产品 用以评价软骨形成的硫酸糖胺聚糖(sGAG)的定量检测 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0821-2022 |
Single use syringes for dispensing{译} 一次性使用配药用注射器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0793.4-2022 |
Preparation and quality control of fluids for hemodialysis and related treatments - Part 4: Quality of dialysate for hemodialysis and related treatments{译} 血液透析和相关治疗用液体的制备和质量管理 第4部分：血液透析和相关治疗用透析液质量 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0634-2022 |
Ophthalmic Instruments Fundus Cameras{译} 眼科仪器 眼底照相机 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0612-2022 |
Disposable human arterial blood sample collector (arterial blood gas needle){译} 一次性使用人体动脉血样采集器(动脉血气针) |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0519-2022 |
Dentistry Tests for bonding to tooth structures{译} 牙科学 与牙齿结构粘接的测试 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0290.4-2022 |
Ophthalmic optics - Intraocular lenses - Part 4: Labeling and information{译} 眼科光学 人工晶状体 第4部分：标签和资料 |
China Pharmaceutics Industry Standards |
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 |
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 |
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 |
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 |
English PDF |
| YY 0307-2022 |
Laser treatment equipment Nd-doped yttrium aluminum garnet laser treatment machine{译} 激光治疗设备 掺钕钇铝石榴石激光治疗机 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1818-2022 |
Dentistry Dental Digital Impression Instrument{译} 牙科学 口腔数字印模仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1847-2022 |
Anti-human globulin test card (column agglutination method){译} 抗人球蛋白检测卡（柱凝集法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1846-2022 |
Endoscopic Surgical Instruments Reusable Abdominal Irrigators{译} 内窥镜手术器械 重复性使用腹部冲吸器 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1842.8-2022 |
Medical devices—Connectors for medical reservoir delivery systems—Part 8: Application of apheresis citrate anticoagulants{译} 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 |
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 |
English PDF |
| YY/T 1841-2022 |
Cardiac Electrophysiological Mapping System{译} 心脏电生理标测系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1839-2022 |
Cardiopulmonary bypass system Venous bubble trap{译} 心肺转流系统 静脉气泡捕获器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1838-2022 |
Disposable peripheral blood collection device{译} 一次性使用末梢采血器 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1834-2022 |
X-ray blood irradiation equipment{译} X射线血液辐照设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1832-2022 |
Implantable devices for sports medicine - Suture tensile test method{译} 运动医学植入器械 缝线拉伸试验方法 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1823-2022 |
Cardiovascular implants - Nitinol alloy nickel ion release test method{译} 心血管植入物 镍钛合金镍离子释放试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1822-2022 |
Dentistry{译} 牙科学 口镜 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1819-2022 |
Dentistry Diaphragms for orthodontic appliances{译} 牙科学 正畸矫治器用膜片 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1816-2022 |
Surgical Implants Synthetic Non-absorbable Mesh Dural (spinal) Membrane Mesh{译} 外科植入物 合成不可吸收补片 硬脑（脊）膜补片 |
China Pharmaceutics Industry Standards |
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{译} 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 |
English PDF |
| YY/T 1814-2022 |
Surgical Implants Synthetic Non-absorbable Meshes Hernia Repair Meshes{译} 外科植入物 合成不可吸收补片 疝修补补片 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1812-2022 |
Characterization of physical and chemical properties of biodegradable biomedical metal materials{译} 可降解生物医用金属材料理化特性表征 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1811-2022 |
Complement 4 Assay Kit (Immunoturbidimetric Assay){译} 补体4测定试剂盒（免疫比浊法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1807-2022 |
Dentistry Rapid non-destructive testing of main components in restorative metal materials Hand-held X-ray fluorescence spectrometer method (semi-quantitative method){译} 牙科学 修复用金属材料中主要成分的快速无损检测 手持式X射线荧光光谱仪法（半定量法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1769-2022 |
Medical Devices for Human Assisted Reproductive Technology Artificial Insemination Catheters{译} 人类辅助生殖技术用医疗器械 人工授精导管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1629.3-2022 |
Knives for electric bone tissue surgery equipment - Part 3: Drill bits{译} 电动骨组织手术设备刀具 第3部分：钻头 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1282-2022 |
Disposable intravenous indwelling needle{译} 一次性使用静脉留置针 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1226-2022 |
Human papillomavirus nucleic acid (typing) detection kit{译} 人乳头瘤病毒核酸(分型)检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1021.1-2022 |
Dentistry - Extracting forceps - Part 1: General requirements{译} 牙科学 拔牙钳 第1部分：通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1011-2022 |
Dentistry - Nominal diameters and designations of rotary instruments{译} 牙科学 旋转器械的公称直径和标号 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0967-2022 |
Dentistry Rods for rotary and reciprocating instruments{译} 牙科学 旋转和往复运动器械的杆 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0937-2022 |
Technical requirements for ultrasonic tissue-mimicking phantoms{译} 超声仿组织体模的技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0934-2022 |
Medical dynamic digital X-ray image detector{译} 医用动态数字化X射线影像探测器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0933-2022 |
Medical General Photography Digital X-ray Image Detector{译} 医用普通摄影数字化X射线影像探测器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0916.6-2022 |
Small bore connections for medical liquids and gases - Part 6: Connections for axonal applications{译} 医用液体和气体用小孔径连接件 第6部分：轴索应用连接件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0916.3-2022 |
Small bore connectors for medical liquids and gases - Part 3: Connectors for gastrointestinal applications{译} 医用液体和气体用小孔径连接件 第3部分：胃肠道应用连接件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0871-2022 |
Ophthalmic optics. Contact lenses. Hygienic handling of contact lenses for multiple patient try-ins.{译} 眼科光学 接触镜 多患者试戴接触镜的卫生处理 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0809.10-2022 |
Surgical implants - Partial and total hip prostheses - Part 10: Determination of the static load resistance of the combined femoral head{译} 外科植入物 部分和全髋关节假体 第10部分：组合式股骨头抗静载力测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0803.1-2022 |
Dentistry - Endodontic instruments - Part 1: General requirements{译} 牙科学 根管器械 第1部分:通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0794-2022 |
Specific technical requirements for image plate imaging device for X-ray photography{译} X射线摄影用影像板成像装置专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0719.5-2022 |
Ophthalmic optics - Contact lens care products - Part 5: Determination of the physical compatibility of contact lenses and contact lens care products{译} 眼科光学 接触镜护理产品 第5部分：接触镜与接触镜护理产品物理相容性的测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0681.12-2022 |
Test methods for sterile medical device packaging - Part 12: Soft barrier materials rub resistance{译} 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 |
English PDF |
| YY/T 0646-2022 |
Small Pressure Steam Sterilizer{译} 小型压力蒸汽灭菌器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0593-2022 |
Ultrasonic Transcranial Doppler Blood Flow Analyzer{译} 超声经颅多普勒血流分析仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0346-2022 |
Osseosynthetic implant Metal femoral neck fixation screw{译} 骨接合植入物 金属股骨颈固定钉 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0321.1-2022 |
Disposable anesthesia puncture kit{译} 一次性使用麻醉穿刺包 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0296-2022 |
Disposable injection needle identification color code{译} 一次性使用注射针 识别色标 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1830-2022 |
Electric Pneumatic Hemostat{译} 电动气压止血仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0795-2022 |
Specific technical requirements for oral and maxillofacial cone beam computed tomography equipment{译} 口腔颌面锥形束计算机体层摄影设备专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0740-2022 |
Special technical requirements for medical angiographic X-ray machines{译} 医用血管造影X射线机专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1821-2022 |
Calculation method of size-specific dose estimation for X-ray computed tomography equipment{译} X射线计算机体层摄影设备体型特异性剂量估算值计算方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1817-2022 |
Thyroglobulin Assay Kit (Chemiluminescent Immunoassay){译} 甲状腺球蛋白测定试剂盒(化学发光免疫分析法) |
China Pharmaceutics Industry Standards |
English PDF |
| YY 1289-2022 |
Laser Therapy Equipment Ophthalmic Laser Photocoagulation{译} 激光治疗设备 眼科激光光凝仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0650-2022 |
General technical requirements for radiofrequency ablation therapy equipment{译} 射频消融治疗设备通用技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0290.8-2022 |
Ophthalmic optics - Intraocular lenses - Part 8: Basic requirements{译} 眼科光学 人工晶状体 第8部分：基本要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0719.2-2022 |
Ophthalmic optics - Contact lens care products - Part 2: Basic requirements{译} 眼科光学 接触镜护理产品 第2部分：基本要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1064-2022 |
Dentistry - General requirements for drill bits for dental implantology{译} 牙科学 牙科种植手术用钻头通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1043.1-2022 |
Dentistry - Non-mobile dental units and dental patient chairs - Part 1: General requirements{译} 牙科学 非移动的牙科治疗机和牙科病人椅 第1部分：通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
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