Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| 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 |
 English PDF |
| YY/T 1751-2020 |
Laser Therapy Equipment Semiconductor Laser Nasal Radiation Therapy Device{译} 激光治疗设备 半导体激光鼻腔内照射治疗仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1746-2020 |
Absorbable surgical sutures - Test method for breaking strength after in vitro hydrolysis{译} 可吸收性外科缝线 体外水解后断裂强力试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1744-2020 |
Tissue engineered medical device products Bioactive ceramics Measurement method of cell migration in porous materials{译} 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 |
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 |
English PDF |
| YY/T 1737-2020 |
Analytical Methods for Bioburden Control Levels of Medical Devices{译} 医疗器械生物负载控制水平的分析方法 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1631.2-2020 |
Compatibility determination of blood transfusion set and blood components - Part 2: Assessment of blood component damage{译} 输血器与血液成分相容性测定 第2部分：血液成分损伤评定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1629.5-2020 |
Electric Bone Tissue Surgery Equipment Knives Part 5: Saw Blades{译} 电动骨组织手术设备刀具 第5部分：锯片 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1629.4-2020 |
Electric Bone Tissue Surgery Equipment Cutter Part 4: Milling Cutter{译} 电动骨组织手术设备刀具 第4部分：铣刀 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1477.6-2020 |
Standard test model for evaluating the performance of contact wound dressings - Part 6: An animal model of refractory type 2 diabetic wounds for evaluating the performance of promoting wound healing{译} 接触性创面敷料性能评价用标准试验模型 第6部分：评价促创面愈合性能的动物2型糖尿病难愈创面模型 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1293.6-2020 |
Contact wound dressings Part 6: Mussel mucin dressings{译} 接触性创面敷料 第6部分：贻贝黏蛋白敷料 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0953—2020 |
Medical carboxymethyl chitosan{译} 医用羧甲基壳聚糖 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0809.2—2020 |
Surgical implants - Partial and total hip prostheses - Part 2: Metal, ceramic and plastic articular surfaces{译} 外科植入物 部分和全髋关节假体 第2部分：金属、陶瓷及塑料关节面 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0707—2020 |
Special technical conditions for mobile photographic X-ray machines{译} 移动式摄影X射线机专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0664—2020 |
Medical Device Software Software Lifecycle Process{译} 医疗器械软件 软件生存周期过程 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0651.2—2020 |
Surgical implants Wear of total hip prostheses Part 2: Measurement methods{译} 外科植入物 全髋关节假体的磨损 第2部分：测量方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0616.7-2020 |
Disposable medical gloves Part 7: Immunological determination of antigenic protein content{译} 一次性使用医用手套 第7部分：抗原性蛋白质含量免疫学测定方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0611—2020 |
Disposable intravenous nutrition infusion bag{译} 一次性使用静脉营养输液袋 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0342—2020 |
Surgical implants - Determination of flexural strength and stiffness of bone plates{译} 外科植入物 接骨板弯曲强度和刚度的测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0285.6-2020 |
Intravascular catheters - Sterile single-use catheters - Part 6: Subcutaneous implantable drug delivery devices{译} 血管内导管 一次性使用无菌导管第6部分：皮下植入式给药装置 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0105—2020 |
Intradermal needle{译} 皮内针 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 1727-2020 |
Oral mucosal exudate human immunodeficiency virus antibody detection kit (colloidal gold immunochromatography){译} 口腔黏膜渗出液人类免疫缺陷病毒抗体检测试剂盒（胶体金免疫层析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1711-2020 |
Gated interface for radiotherapy{译} 放射治疗用门控接口 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1736-2020 |
Test method for evaluating durability and deformation of knee tibial inserts under conditions of high flexion{译} 评价高屈曲条件下膝关节胫骨衬垫耐久性和变形试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1734-2020 |
Iodine solution protective cap for peritoneal dialysis{译} 腹膜透析用碘液保护帽 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1732-2020 |
Special technical conditions for oral curved tomography X-ray machine{译} 口腔曲面体层X射线机专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1731-2020 |
Human Gene Single Nucleotide Polymorphism (SNP) Detection Kit{译} 人基因单核苷酸多态性（SNP）检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1730-2020 |
Disposable hemodialysis catheter{译} 一次性使用血液透析导管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1729-2020 |
Fungal (1-3)-β-D glucan assay kit{译} 真菌(1-3)-β-D葡聚糖测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1724-2020 |
Free Triiodothyronine Assay Kit{译} 游离三碘甲状腺原氨酸测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1716-2020 |
Tissue engineered medical device products Characterization of ceramic and mineral scaffolds{译} 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 |
English PDF |
| YY/T 1715-2020 |
Surgical Implants Yttria Stabilized Tetragonal Zirconia (Y-TZP) Ceramic Materials{译} 外科植入物 氧化钇稳定四方氧化锆（Y-TZP）陶瓷材料 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1714-2020 |
Standard method for finite element analysis of non-assembled metal hip femoral stems{译} 非组合式金属髋关节股骨柄有限元分析标准方法 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1701-2020 |
Medical Ti-6Al-4V/Ti-6Al-4V ELI Powder for Additive Manufacturing{译} 用于增材制造的医用Ti-6Al-4V/Ti-6Al-4V ELI粉末 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1698-2020 |
Medical devices for human in vitro assisted reproductive technology{译} 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 |
English PDF |
| YY/T 1216—2020 |
Alpha Fetoprotein Assay Kit{译} 甲胎蛋白测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1133—2020 |
Passive Surgical Implant Combination Instrument Metal Bone Drill{译} 无源外科植入物联用器械 金属骨钻 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0809.12—2020 |
Surgical implants - Partial and total hip prostheses - Part 12: Test method for acetabular cup deformation{译} 外科植入物 部分和全髋关节假体 第12部分：髋臼杯形变测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0726—2020 |
Devices for passive surgical implants - General requirements{译} 无源外科植入物联用器械 通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0719.6—2020 |
Ophthalmic optics - Contact lens care products - Part 6: Guidelines for the determination of expiration date{译} 眼科光学 接触镜护理产品 第6部分：有效期测定指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0694—2020 |
Standard test method for elastic recoil of balloon-expandable stents{译} 球囊扩张支架弹性回缩的标准测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0651.3—2020 |
Surgical implants Wear of total hip prostheses - Part 3: Load and displacement parameters of orbital bearing type wear testing machines and associated test environmental conditions{译} 外科植入物 全髋关节假体的磨损 第3部分：轨道轴承型磨损试验机的载荷和位移参数及相关的试验环境条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0628—2020 |
Dentistry Dental Equipment Graphic Symbols{译} 牙科学 牙科设备图形符号 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0513.2—2020 |
Allogeneic Restorative Materials Part 2: Cryogenically Frozen and Freeze-Dried Bone{译} 同种异体修复材料 第2部分：深低温冷冻骨和冷冻干燥骨 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0345.1—2020 |
Surgical implants - Metal pins - Part 1: General requirements{译} 外科植入物 金属骨针 第1部分：通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0286.4—2020 |
Special infusion sets - Part 4: Infusion sets for single-use pressure infusion devices{译} 专用输液器 第4部分:一次性使用压力输液设备用输液器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0010—2020 |
Special technical conditions for intraoral imaging dental X-ray machines{译} 口内成像牙科X射线机专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1739-2020 |
Cardiopulmonary Bypass Systems Centrifugal Pump Heads{译} 心肺转流系统 离心泵泵头 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1726-2020 |
Concentration gradient agar diffusion strips{译} 浓度梯度琼脂扩散药敏条 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1725-2020 |
Bacterial and Fungal Infection Multiplex Nucleic Acid Detection Kit{译} 细菌和真菌感染多重核酸检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1723-2020 |
High-throughput gene sequencer{译} 高通量基因测序仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1722-2020 |
Prealbumin Assay Kit (Immunoturbidimetric){译} 前白蛋白测定试剂盒（免疫比浊法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1721-2020 |
Free Thyroxine Assay Kit{译} 游离甲状腺素测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1709-2020 |
Evaluation of Measurement Uncertainty of Calibrators for In Vitro Diagnostic Reagents{译} 体外诊断试剂用校准物测量不确定度评定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1696-2020 |
Dentistry Intraoral Plastic Knife{译} 牙科学 口内塑形刀 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0803.2—2020 |
Dentistry Root canal instruments Part 2: Enlarging drills{译} 牙科学 根管器械 第2部分：扩大钻 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0802—2020 |
Handling of medical devices Information provided by medical device manufacturers{译} 医疗器械的处理 医疗器械制造商提供的信息 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0485—2020 |
Disposable cardioplegia infusion device{译} 一次性使用心脏停跳液灌注器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1753-2020 |
Guidelines for Filling in the Database of Unique Identification of Medical Devices{译} 医疗器械唯一标识数据库填报指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1752-2020 |
Medical Device Unique Identification Database Basic Data Set{译} 医疗器械唯一标识数据库基本数据集 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1676-2020 |
Ultrasound endoscope{译} 超声内窥镜 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1718-2020 |
Medical devices for human in vitro assisted reproductive technology Embryo transfer catheter{译} 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 |
English PDF |
| YY/T 1717-2020 |
Nucleic acid extraction kit (magnetic bead method){译} 核酸提取试剂盒（磁珠法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1695-2020 |
Medical devices for human assisted reproductive technology - Method for the detection of amino acids in culture fluids{译} 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 |
English PDF |
| YY/T 1667—2020 |
Chlamydia pneumoniae IgG antibody detection kit (enzyme-linked immunosorbent assay){译} 肺炎衣原体IgG抗体检测试剂盒（酶联免疫吸附法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1477.5—2020 |
Standard test models for evaluating the performance of contact wound dressings - Part 5: In vitro models for evaluating hemostatic performance{译} 接触性创面敷料性能评价用标准试验模型 第5部分：评价止血性能的体外模型 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0771.2—2020 |
Medical Devices of Animal Origin Part 2: Control of Source, Collection and Disposal{译} 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 |
English PDF |
| YY/T 0771.1—2020 |
Medical Devices of Animal Origin Part 1: Risk Management Applications{译} 动物源医疗器械 第1部分：风险管理应用 |
China Pharmaceutics Industry Standards |
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{译} 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 |
English PDF |
| YY 0336—2020 |
Disposable sterile vaginal dilators{译} 一次性使用无菌阴道扩张器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0286.6—2020 |
Special infusion sets - Part 6: Disposable graduated flow-adjustable infusion sets{译} 专用输液器 第6部分：一次性使用刻度流量调节式输液器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1684-2020 |
Dentistry Apex Locator{译} 牙科学 牙根尖定位仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1693-2020 |
Dentistry Maxillary Sinus Membrane Lifter{译} 牙科学 上颌窦膜提升器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1720-2020 |
Test method for separation force of combined acetabular components{译} 组合式髋臼部件分离力试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1710-2020 |
Disposable abdominal trocar{译} 一次性使用腹部穿刺器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 1116—2020 |
Absorbable Surgical Sutures{译} 可吸收性外科缝线 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0823—2020 |
Dentistry Fluoride Anti-Caries Materials{译} 牙科学 氟化物防龋材料 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0573.4—2020 |
Single-use sterile syringes Part 4: Preventing re-use of syringes{译} 一次性使用无菌注射器 第4部分：防止重复使用注射器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0167—2020 |
non-absorbable surgical sutures{译} 非吸收性外科缝线 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1671—2020 |
Ultrasound probe puncture stand{译} 超声探头穿刺架 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0450.1—2020 |
Disposable sterile endovascular catheter accessories Part 1: Guiding instruments{译} 一次性使用无菌血管内导管辅件 第1部分：导引器械 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1656—2020 |
Morphine detection kit (colloidal gold method){译} 吗啡检测试剂盒（胶体金法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0621.2—2020 |
Dentistry - Compatibility testing - Part 2: Ceramic-ceramic systems{译} 牙科学 匹配性试验 第2部分：陶瓷-陶瓷体系 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0292.2—2020 |
Medical diagnostic X-ray radiation protection devices - Part 2: Transparent protective panels{译} 医用诊断X射线辐射防护器具 第2部分：透明防护板 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0292.1—2020 |
Medical diagnostic X-ray radiation protection devices - Part 1: Determination of the attenuation properties of materials{译} 医用诊断X射线辐射防护器具 第1部分：材料衰减性能的测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0833-2020 |
General technical requirements for limb compression physiotherapy equipment{译} 肢体加压理疗设备通用技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0086-2020 |
Medical refrigerator{译} 医用冷藏箱 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1694-2020 |
Body surface optical positioning equipment for radiotherapy - Performance and test methods{译} 放射治疗用体表光学摆位设备 性能和试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1692-2020 |
Dentistry Hot-melt gutta-percha filling machine{译} 牙科学 热熔牙胶充填机 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1691-2020 |
Dentistry Handpiece Torque Transmitter{译} 牙科学 手机扭矩传送器 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1707-2020 |
Surgical implants - Differential scanning calorimetry of polyetheretherketone polymers and their composites for implantable medical devices{译} 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 |
English PDF |
| YY/T 1706.1-2020 |
Surgical implants - Plasma sprayed pure titanium coating for metallic surgical implants - Part 1: General requirements{译} 外科植入物 金属外科植入物等离子喷涂纯钛涂层 第1部分：通用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1705-2020 |
Surgical implants - Method for determination of impact resistance of ceramic femoral head of hip joint prosthesis{译} 外科植入物 髋关节假体陶瓷股骨头抗冲击性能测定方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1704.2-2020 |
Disposable cervical dilators Part 2: Inflatable{译} 一次性使用宫颈扩张器 第2部分：膨胀式 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1704.1-2020 |
Disposable cervical dilators Part 1: Progressive{译} 一次性使用宫颈扩张器 第1部分：渐进式 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1703-2020 |
Dentistry Orthodontic coil springs{译} 牙科学 正畸用螺旋弹簧 |
China Pharmaceutics Industry Standards |
English PDF |
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