Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1471-2016 |
(IUDs containing copper indomethacin silicone rubber technical requirements and test methods for indole) 含铜宫内节育器用含吲哚美辛硅橡胶技术要求与试验方法 |
China Medicine & Medical Device Standards |
 English PDF |
| YY/T 1470-2016 |
(Disposable umbilical cord cut (cut) breaker) 一次性使用脐带剪（切）断器 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1469-2016 |
(Portable electric infusion pump) 便携式电动输液泵 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1467-2016 |
(Medical aid bandage bandaging dressing) 医用包扎敷料救护绷带 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1466-2016 |
(Oral X-ray tomography apparatus digitized bone mineral density evaluation method) 口腔x射线数字化体层摄影设备骨密度测定评价方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1465.2-2016 |
(Evaluation of immunological methods of medical devices - Part 2 serum immunoglobulins and complement components by ELISA) 医疗器械免疫原性评价方法第2部分血清免疫球蛋白和补体成分测定elisa法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1465.1-2016 |
(Evaluation of immunological methods of medical devices - Part 1 in vitro T lymphocyte transformation test) 医疗器械免疫原性评价方法 第1部分:体外t淋巴细胞转化试验 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1464-2016 |
(Development of medical devices - Low temperature steam sterilization formaldehyde sterilization process, validation and routine control) 医疗器械灭菌低温蒸汽甲醛灭菌过程的开发、确认和常规控制要求 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1463-2016 |
(Medical device sterilization and microbial challenge to confirm the selection of site contamination Guide) 医疗器械灭菌确认选择微生物挑战和染菌部位的指南 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1462-2016 |
(Influenza A H1N1 influenza virus RNA detection kit (fluorescence PCR method)) 甲型h1n1流感病毒rna检测试剂盒（荧光pcr法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1461-2016 |
(IMA assay reagent (kit)) 缺血修饰白蛋白测定试剂（盒） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1460-2016 |
(Blood rheometer) 血液流变仪 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1459-2016 |
(Human gene in situ hybridization detection kit) 人类基因原位杂交检测试剂盒 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1458-2016 |
(Anti-thyroid peroxidase antibodies quantitative detection reagent (box) (chemiluminescent immunoassay)) 抗甲状腺过氧化物酶抗体定量检测试剂（盒）（化学发光免疫分析法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1457-2016 |
(The method of determination of oligomeric siloxane-based substances active surgical implants silicone gel-filled breast implants) 无源外科植入物硅凝胶填充乳房植入物中寡聚硅氧烷类物质测定方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1456-2016 |
(Ferritin quantitative detection reagent (box)) 铁蛋白定量检测试剂（盒） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1455-2016 |
(Application Reference measurement procedure for the catalytic activity of the enzyme concentration assignment and Uncertainty Evaluation Guide) 应用参考测量程序对酶催化活性浓度赋值及其不确定度评定指南 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1454-2016 |
(Self-vitro diagnostic medical devices for detecting the basic requirements) 自我检测用体外诊断医疗器械基本要求 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1452-2016 |
(Dry blood cell analyzer (centrifugation)) 干式血液细胞分析仪（离心法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1451-2016 |
(Brain natriuretic peptide and amino-terminal pro-brain natriuretic peptide detection reagent (box) (quantitative labeled immunosorbent assay)) 脑利钠肽和氨基末端脑利钠肽前体检测试剂（盒）（定量标记免疫分析法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1450-2016 |
(Apolipoprotein A-I assay reagent (kit)) 载脂蛋白a-i测定试剂（盒） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1449.3-2016 |
(Cardiovascular implants artificial heart valves - Part 3: Transcatheter implantation of artificial heart valves) 心血管植入物人工心脏瓣膜 第3部分：经导管植入式人工心脏瓣膜 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1448-2016 |
(Lipoprotein (a) Assay Kit) 脂蛋白（a）测定试剂盒 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1447-2016 |
(Surgical implants implants apatite-forming ability in vitro assessment) 外科植入物植入材料磷灰石形成能力的体外评估 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1446-2016 |
(Medical endoscope endoscopic instruments palm-Loaded) 医用内窥镜内窥镜器械掌式器械 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1444-2016 |
(Total protein assay kit) 总蛋白测定试剂盒 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1442-2016 |
(β2- microglobulin quantitative detection reagent (box)) β2-微球蛋白定量检测试剂（盒） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1441-2016 |
(Performance evaluation of in vitro diagnostic medical devices General requirements) 体外诊断医疗器械性能评估通用要求 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1440-2016 |
(Flexible and high-pressure medical gas systems for use with connection) 与医用气体系统一起使用的高压挠性连接 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1439.2-2016 |
(Medical gas pressure regulator Part 2: Pressure regulators and bus line pressure regulator) 医用气体压力调节器第2部分：汇流排压力调节器和管道压力调节器 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1438-2016 |
(Anaesthetic and respiratory equipment evaluation of spontaneous breathing lung function in peak expiratory flow meter) 麻醉和呼吸设备评价自主呼吸者肺功能的呼气峰值流量计 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1437-2016 |
Medical devices—Guidance on the application of YY/T 0316 医疗器械YY/T0316应用指南 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1436-2016 |
(Lavage Requirements and test methods for ostomy and incontinence aids) 造口术和失禁辅助器具灌洗器要求和试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1434-2016 |
(Human Assisted Reproductive Technology in vitro mouse embryo in vitro testing of medical devices) 人类体外辅助生殖技术用医疗器械体外鼠胚试验 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1433-2016 |
(Medical Devices flexible packaging material hot seal strength (hot tack strength) Test Method) 医疗器械软性包装材料热态密封强度（热粘强度）试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1432-2016 |
(Test methods for sealing parameters flexible packaging materials for medical devices is determined by measuring the heat-sealing strength of the sample) 通过测量热封试样的密封强度确定医疗器械软性包装材料的热封参数的试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1431-2016 |
(Surgical implants medical grade UHMWPE yarn) 外科植入物医用级超高分子量聚乙烯纱线 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1430-2016 |
(Small punch test method for surgical implant with ultrahigh molecular weight polyethylene) 外科植入物用超高分子量聚乙烯小冲孔试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1429-2016 |
(Surgical implants bone cement acrylic resin, acrylic resin orthopedic bone cement bending fatigue performance test method) 外科植入物丙烯酸类树脂骨水泥矫形外科用丙烯酸类树脂骨水泥弯曲疲劳性能试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1428-2016 |
(Terminology spinal implant) 脊柱植入物相关术语 |
China Medicine & Medical Device Standards |
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 |
English PDF |
| YY/T 1426.2-2016 |
(Surgical implants for total knee prosthesis worn Part 2: The measurement method) 外科植入物全膝关节假体的磨损 第2部分：测量方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1426.1-2016 |
(Wear surgical implants for total knee prosthesis - Part 1: Load and displacement parameters for wear testing machine load control and related environmental conditions for test) 外科植入物全膝关节假体的磨损 第1部分：载荷控制的磨损试验机的载荷和位移参数及相关的试验环境条件 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1425-2016 |
(Injection needle Performance Standard Test Method for Resistance of Materials Protective Clothing) 防护服材料抗注射针穿刺性能标准试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1424-2016 |
(Chlamydia trachomatis DNA detection kit (fluorescence PCR method)) 沙眼衣原体dna检测试剂盒（荧光pcr法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1423-2016 |
(Pylori antibody detection kit (colloidal gold)) 幽门螺杆菌抗体检测试剂盒（胶体金法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1421-2016 |
(Apo B assay kit) 载脂蛋白b测定试剂盒 |
China Medicine & Medical Device Standards |
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 |
English PDF |
| YY/T 1419-2016 |
(Ultrasonic elastic properties of quasi-static strain test methods) 超声准静态应变弹性性能试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1418-2016 |
(Ophthalmic optics and instruments express the human eye aberrations) 眼科光学和仪器人眼像差表述 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1416.2-2016 |
(One-time use of human blood sample collection container determination of the amount of additives Part 2: sodium citrate) 一次性使用人体静脉血样采集容器中添加剂量的测定方法 第2部分: 柠檬酸钠 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1292.3-2016 |
(Reproductive and developmental toxicity of medical devices - Part 3: generation reproductive toxicity study) 医疗器械生殖和发育毒性试验 第3部分：一代生殖毒性试验 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1287.3-2016 |
(Brain external drainage systems - Part 3: Brain external drainage catheter) 颅脑外引流系统 第3部分：颅脑外引流导管 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1287.2-2016 |
(Brain external drainage systems - Part 2: lumbar puncture drainage of cerebrospinal fluid collection device) 颅脑外引流系统 第2部分：腰椎穿刺脑脊液外引流收集装置 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1286.2-2016 |
(Platelet storage bag performance - Part 2: platelet storage performance evaluation guidelines) 血小板贮存袋性能 第2部分：血小板贮存性能评价指南 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1015-2016 |
(Ophthalmic Needle Holders) 眼用持针钳 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0980.2-2016 |
(Disposable biopsy needle Part 2: Manual) 一次性使用活组织检查针 第2部分：手动式 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0869.2-2016 |
(Medical device adverse event classification coding structure Part 2: Evaluation of coding) 医疗器械不良事件分级编码结构 第2部分：评价编码 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0869.1-2016 |
(Medical device adverse event classification coding structure - Part 1: Event type codes) 医疗器械不良事件分级编码结构 第1部分：事件类型编码 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0752-2016 |
(Electric bone surgery equipment) 电动骨组织手术设备 |
China Medicine & Medical Device Standards |
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 |
English PDF |
| YY/T 0652-2016 |
(Graft material wear debris polymers and metals separation and characterization) 植入物材料的磨损聚合物和金属材料磨屑分离和表征 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0651.1-2016 |
(Wear surgical implants - Part 1 total hip prosthesis: load and displacement parameters for wear testing machine and related environmental conditions for test) 外科植入物全髋关节假体的磨损 第1部分：磨损试验机的载荷和位移参数及相关的试验环境条件 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0616.2-2016 |
(Disposable medical gloves - Part 2: Determination of the shelf life requirements and tests) 一次性使用医用手套 第2部分：测定货架寿命的要求和试验 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0616.1-2016 |
(Disposable medical gloves - Part 1: Requirements and test biological evaluation) 一次性使用医用手套 第1部分：生物学评价要求与试验 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0586-2016 |
(Medical Polymer Co. X-ray opaque Test Method) 医用高分子制品 x射线不透性试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0506.2-2016 |
(Patients, staff and equipment with the surgical drapes, gowns and clean air suits - Part 2: Performance requirements and test methods) 病人、医护人员和器械用手术单、手术衣和洁净服 第2部分：性能要求和试验方法 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0496-2016 |
(Dentistry and denture wax casting wax) 牙科学铸造蜡和基托蜡 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0486-2016 |
(ETT laser surgery requires special labeling and random information) 激光手术专用气管导管标记和随机信息的要求 |
China Medicine & Medical Device Standards |
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 |
English PDF |
| YY/T 0466.1-2016 |
(Symbols - Part 1 medical devices for medical device labels, labeling and information: General requirements) 医疗器械用于医疗器械标签、标记和提供信息的符号 第1部分：通用要求 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0316-2016 |
(Medical Device Risk Management for Medical Device Applications) 医疗器械风险管理对医疗器械的应用 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0127.18-2016 |
(Oral Biological evaluation of medical devices - Part 18: dentin barrier Cytotoxicity test) 口腔医疗器械生物学评价 第18部分：牙本质屏障细胞毒性试验 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0502-2016 |
Joint replacement implants-Knee joint prostheses 关节置换植入物膝关节假体 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0315-2016 |
Wrought titanium and titanium dental implant 钛及钛合金牙种植体 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1443-2016 |
(Influenza virus antigen detection kit (immunochromatography)) 甲型流感病毒抗原检测试剂盒（免疫层析法） |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0294.1-2016 |
(Surgical instruments - Metallic materials - Part 1: Steel) |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 1253-2015 |
Low density lipoprotein (LDL) cholesterol assay kit 低密度脂蛋白胆固醇测定试剂（盒） |
China Medicine & Medical Device Standards |
English PDF |
| YY 0954-2015 |
Nonactive surgical implants. Type I collagen implants. Specific requirements 无源外科植入物-I型胶原蛋白植入剂 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0953-2015 |
Medical carboxymethylchitosan 医用羧甲基壳聚糖 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0952-2015 |
Temperature control blanket for medical use 医用控温毯 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0951-2015 |
Interferential current therapy instrument 干扰电治疗设备 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0950-2015 |
Extracorporeal pressure wave therapy devices by compressed air 气压弹道式体外压力波治疗设备 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0948-2015 |
Cardiopulmonary bypass systems. Arteriovenous cannula for single use 心肺转流系统一次性使用动静脉插管 |
China Medicine & Medical Device Standards |
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 |
English PDF |
| YY 0832.2-2015 |
Stereotactic and planning system for radiotherapy with X-radiation. Part 2:Stereotactic and planning system for radiotherapy with X-radiation for body lesion 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 Medicine & Medical Device Standards |
English PDF |
| YY 0831.2-2015 |
Stereotactic radiotherapy system with gamma beam. Part 2: Multi-Source stereotactic radiotherapy system with gamma beam for body lesion 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 Medicine & Medical Device Standards |
English PDF |
| YY 0605.9-2015 |
Implants for surgery. Metallic materials. Part 9: Wrought high nitrogen stainless steel 外科植入物 金属材料 第9部分：锻造高氮不锈钢 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0603-2015 |
Cardiovascular implants and artificial organs. Hard-shell cardiotomy/ venom reservoir systems(with/without filter)and soft venous reservoir bags 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 Medicine & Medical Device Standards |
English PDF |
| YY 0599-2015 |
Therapeutic laser equipment. Excimer laser cornea ametropia cure system 激光治疗设备 准分子激光角膜屈光治疗机 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0598-2015 |
Concentrates for haemodialysis and related therapies 血液透析及相关治疗用浓缩物 |
China Medicine & Medical Device Standards |
English PDF |
| YY 0572-2015 |
Water for haemodialysis and related therapies 血液透析及相关治疗用水 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0993-2015 |
Biological evaluation of medical devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay) 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 Medicine & Medical Device Standards |
English PDF |
| YY/T 0991-2015 |
Clinical trial guideline for orthodontic brackets 正畸托槽临床试验指南 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0990-2015 |
Clinical trial guideline for polymer-based dental restorative materials 聚合物基牙体修复材料临床试验指南 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0967.2-2015 |
Dental rotary instnunents. Shanks. Part2:Shanks made of plastics 牙科旋转器械 杆 第2部分::塑料杆 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0967.1-2015 |
Dental rotary instruments. Shanks. Part 1:Shanks made of metals 牙科旋转器械 杆 第1部分:金属杆 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0921-2015 |
Medical absorbent viscose wadding 医用吸水性粘胶纤维 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0915-2015 |
(Dentistry orthodontic brackets and buccal tubes) 牙科学 正畸用托槽和颊面管 |
China Medicine & Medical Device Standards |
English PDF |
| YY/T 0914-2015 |
Dentistry. Laser welding 牙科学 激光焊接 |
China Medicine & Medical Device Standards |
English PDF |
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