Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| 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 |
 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 |
English PDF |
| YY/T 0061—2021 |
Specific electromagnetic wave therapy device{译} 特定电磁波治疗器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1757-2021 |
medical freezer{译} 医用冷冻保存箱 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 1741-2021 |
Antithrombin Ⅲ Assay Kit{译} 抗凝血酶Ⅲ测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0290.2—2021 |
Ophthalmic optics - Intraocular lenses - Part 2: Optical properties and test methods{译} 眼科光学 人工晶状体 第2部分：光学性能及测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1783-2021 |
Endoscopic surgical instruments Reusable abdominal trocar{译} 内镜手术器械 重复性使用腹部穿刺器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1779-2021 |
Dentistry Orthodontic anchorage nails{译} 牙科学 正畸支抗钉 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1776-2021 |
Determination of Lactide Monomer Content in Polylactic Acid Materials for Surgical Implants{译} 外科植入物聚乳酸材料中丙交酯单体含量的测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1775.1-2021 |
Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants{译} 可吸收医疗器械生物学评价 第1部分：可吸收植入物指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1772-2021 |
Surgical implants - Test method for galvanic corrosion in electrolytes{译} 外科植入物 电解液中电偶腐蚀试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1771-2021 |
Determination of phase transition temperature of NiTi shape memory alloy by bending-free recovery method{译} 弯曲-自由恢复法测试镍钛形状记忆合金相变温度 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1770.1-2021 |
Medical Device Thrombosis Test Part 1: In Vivo Thrombosis Test in Dogs{译} 医疗器械血栓形成试验 第1部分：犬体内血栓形成试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1768.2-2021 |
Medical needle injection systems - Requirements and test methods - Part 2: Needles{译} 医用针式注射系统 要求和试验方法 第2部分: 针头 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1768.1-2021 |
Needle injection systems for medical use - Requirements and test methods - Part 1: Needle injection systems{译} 医用针式注射系统 要求和试验方法 第1部分：针式注射系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1767-2021 |
Ultrasound Power Measurement High Intensity Therapeutic Ultrasound (HITU) Transducers and Systems{译} 超声 功率测量 高强度治疗超声（HITU）换能器和系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1766.2-2021 |
Evaluation methods for image quality of X-ray computed tomography equipment - Part 2: Evaluation of low-contrast resolution{译} X射线计算机体层摄影设备图像质量评价方法 第2部分：低对比度分辨率评价 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1766.1-2021 |
Evaluation methods for image quality of X-ray computed tomography equipment - Part 1: Modulation transfer function evaluation{译} X射线计算机体层摄影设备图像质量评价方法 第1部分: 调制传递函数评价 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1756-2021 |
Dentistry reusable periodontal ligament injection rack{译} 牙科学 可重复使用牙周膜注射架 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1755-2021 |
Dentistry Sandblasting Handpieces and Sandblasting Powders{译} 牙科学 喷砂手机和喷砂粉 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1735-2021 |
Hepatitis C virus antibody detection reagent (box) (chemiluminescence immunoassay){译} 丙型肝炎病毒抗体检测试剂（盒）（化学发光免疫分析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1728-2021 |
Clinical laboratory tests and in vitro diagnostic systems Reference methods for in vitro activity detection of yeast-like fungi antibacterial agents associated with infectious diseases{译} 临床实验室检测和体外诊断系统 感染性疾病相关酵母样真菌抗菌剂的体外活性检测参考方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1688-2021 |
Medical Devices for Human Assisted Reproductive Technology-Methods for Staining and Counting Blastocyst Cells{译} 人类辅助生殖技术用医疗器械 囊胚细胞染色和计数方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1679-2021 |
Tissue-engineered medical device products Bone-In vivo guidelines for the preclinical evaluation of bone defects of critical size{译} 组织工程医疗器械产品 骨 体内临界尺寸骨缺损的临床前评价指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1465.7—2021 |
Methods for evaluating the immunogenicity of medical devices Part 7: Flow-liquid-liquid multiplex protein quantification techniques{译} 医疗器械免疫原性评价方法 第7部分：流式液相多重蛋白定量技术 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1416.6—2021 |
Method for determination of dosage in single-use human venous blood sample collection containers - Part 6: Imidazolidinyl urea{译} 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6部分：咪唑烷基脲 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1416.5—2021 |
Determination of Dose Addition in Single-Use Human Venous Blood Sample Collection Containers - Part 5: Glycine{译} 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5部分：甘氨酸 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1035—2021 |
stethoscope{译} 听诊器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1014—2021 |
dentistry dental probe{译} 牙科学 牙探针 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 0742—2021 |
Special technical conditions for gastrointestinal X-ray machines{译} 胃肠X射线机专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0724—2021 |
Special technical conditions for dual energy X-ray absorptiometry{译} 双能X射线骨密度仪专用技术条件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0681.4—2021 |
Test methods for sterile medical device packaging - Part 4: Determination of seal leakage of breathable packaging by dye penetration method{译} 无菌医疗器械包装试验方法 第4部分：染色液穿透法测定透气包装的密封泄漏 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 0629—2021 |
Dentistry Central suction source equipment{译} 牙科学 中央抽吸源设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0567.2—2021 |
Aseptic Processing of Healthcare Products Part 2: Sterile Filtration{译} 医疗保健产品的无菌加工 第2部分：除菌过滤 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0321.2—2021 |
Disposable anesthesia needles{译} 一次性使用麻醉用针 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0286.5—2021 |
Special infusion sets - Part 5: Disposable bottle and bag infusion sets{译} 专用输液器 第5部分：一次性使用吊瓶式和袋式输液器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1773-2021 |
Disposable external peritoneal dialysis tubing{译} 一次性使用腹膜透析外接管 |
China Pharmaceutics Industry Standards |
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 |
English PDF |
| YY/T 1742-2021 |
Adenosine Deaminase Assay Kit{译} 腺苷脱氨酶测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1740.1-2021 |
Medical Mass Spectrometers Part 1: Liquid Chromatography-Mass Spectrometry{译} 医用质谱仪 第1部分：液相色谱-质谱联用仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1712-2021 |
Assistive Surgical Devices and Assisted Surgical Systems Using Robotics{译} 采用机器人技术的辅助手术设备和辅助手术系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1794—2021 |
General technical requirements for oral collagen membranes{译} 口腔胶原膜通用技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1831-2021 |
Treponema pallidum antibody detection kit (immunochromatography){译}{译} 梅毒螺旋体抗体检测试剂盒（免疫层析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1828-2021 |
Anti-Mullerian hormone assay kit (chemiluminescence immunoassay){译}{译} 抗缪勒管激素测定试剂盒（化学发光免疫分析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1820-2021 |
Specific Antinuclear Antibody IgG Detection Kit (Western Blotting){译}{译} 特异性抗核抗体IgG检测试剂盒（免疫印迹法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1801-2021 |
Fetal chromosomal aneuploidy trisomy 21, trisomy 18 and trisomy 13 detection kit (high-throughput sequencing method){译}{译} 胎儿染色体非整倍体21三体、18三体和13三体检测试剂盒（高通量测序法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1791-2021 |
Hepatitis B virus e antibody detection kit (luminescence immunoassay){译}{译} 乙型肝炎病毒e抗体检测试剂盒（发光免疫分析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1789.2-2021 |
In-vitro diagnostic test systems - Performance evaluation methods - Part 2: Accuracy{译}{译} 体外诊断检验系统 性能评价方法 第2部分：正确度 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1784-2021 |
blood gas analyzer{译}{译} 血气分析仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1747-2021 |
Neurovascular Implants Intracranial Arterial Stents{译}{译} 神经血管植入物 颅内动脉支架 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1180-2021 |
Human Leukocyte Antigen (HLA) Genotyping Kit{译}{译} 人类白细胞抗原（HLA）基因分型检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0701-2021 |
Calibrators for Hematology Analyzers{译}{译} 血液分析仪用校准物 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1836-2021 |
Respiratory Virus Multiplex Nucleic Acid Detection Kit{译}{译} 呼吸道病毒多重核酸检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1826-2021 |
Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR Method){译}{译} B群链球菌核酸检测试剂盒（荧光PCR法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1825-2021 |
Red and white blood cell count reference measurement procedures{译}{译} 红细胞和白细胞计数参考测量程序定值结果测量不确定度评定指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1824-2021 |
EB virus nucleic acid detection kit (fluorescent PCR method){译}{译} EB病毒核酸检测试剂盒（荧光PCR法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1204-2021 |
Total bile acid assay kit (enzyme cycle method){译}{译} 总胆汁酸测定试剂盒（酶循环法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1164-2021 |
Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatography){译}{译} 人绒毛膜促性腺激素（HCG）检测试剂盒（胶体金免疫层析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1160-2021 |
Carcinoembryonic Antigen (CEA) Assay Kit{译}{译} 癌胚抗原（CEA）测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0647-2021 |
Passive surgical implants - Specific requirements for breast implants{译}{译} 无源外科植入物 乳房植入物的专用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0500-2021 |
Cardiovascular Implants Vascular Prostheses Tubular Vascular Grafts & Vascular Patches{译}{译} 心血管植入物 血管假体 管状血管移植物和血管补片 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0167-2020 |
非吸收性外科缝线 非吸收性外科缝线 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 1116-2020 |
Absorbable surgical suture 可吸收性外科缝线 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0823-2020 |
牙科学 氟化物防龋材料 牙科学 氟化物防龋材料 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0573.4-2020 |
一次性使用无菌注射器 第4部分：防止重复使用注射器 一次性使用无菌注射器 第4部分：防止重复使用注射器 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0935-2014/XG1-2020 |
Particular specifications for CT injector 《CT造影注射装置专用技术条件》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 1671-2020 |
超声探头穿刺架 超声探头穿刺架 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 0450.1-2020 |
Accessory devices for sterile single-use intravascular catheters--Part 1:Introducers 一次性使用无菌血管内导管辅件 第1部分：导引器械 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 1656-2020 |
吗啡检测试剂盒（胶体金法） 吗啡检测试剂盒（胶体金法） |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0292.1-2020 |
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 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 YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0621.2-2020 |
牙科学 匹配性试验 第2部分：陶瓷-陶瓷体系 牙科学 匹配性试验 第2部分：陶瓷-陶瓷体系 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0292.2-2020 |
医用诊断X射线辐射防护器具 第2部分：透明防护板 医用诊断X射线辐射防护器具 第2部分：透明防护板 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0061-2007/XG1-2020 |
Specified electromagnetic wave therapy equipment 《特定电磁波治疗器》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 0838-2011/XG1-2020 |
Microwave ablation/coagulation equipment 《微波热凝设备》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 1653-2020 |
输液泵用管路 输液泵用管路 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 1182-2020 |
Nucleic acids amplification test reagents(kits) 核酸扩增检测用试剂(盒) |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0809.13-2020 |
外科植入物 部分和全髋关节假体 第13部分：带柄股骨部件头部固定抗扭转力矩的测定 外科植入物 部分和全髋关节假体 第13部分：带柄股骨部件头部固定抗扭转力矩的测定 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0734.5-2020 |
清洗消毒器 第5部分：对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器 要求和试验 清洗消毒器 第5部分：对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器 要求和试验 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0513.3-2020 |
同种异体修复材料 第3部分：脱矿骨 同种异体修复材料 第3部分：脱矿骨 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0086-2020 |
医用冷藏箱 医用冷藏箱 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0595-2020 |
Medical devices—Application of risk management to medical devices 医疗器械 质量管理体系YY/T 0287-2017 应用指南 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 0852-2011/XG1-2020 |
Sterile surgical films for single use 《一次性使用无菌手术膜》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0931-2014/XG1-2020 |
Medical endoscopes—Endotherapy device—Loop ligature 《医用内窥镜 内窥镜器械 圈形套扎装置》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 0104-2018/XG1-2020 |
Three-edged needle 《三棱针》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0148-2006/XG1-2020 |
Medical adhesive bandages-General requirements 《医用胶带 通用要求》行业标准第1号修改单 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 0833-2020 |
肢体加压理疗设备通用技术要求 肢体加压理疗设备通用技术要求 |
China YY-Medicine & Medical Device Industry Standards |
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 |
English PDF |
| YY/T 1750-2020 |
Ultrasonic soft tissue cutting hemostatic surgical equipment{译} 超声软组织切割止血手术设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1749-2020 |
Ultrasonic elasticity measurement device of liver tissue based on external vibration{译} 基于外部振动的肝组织超声弹性测量设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1733-2020 |
Radiation Sterilization of Medical Devices—Guidelines for Dose Distribution Testing of Irradiation Devices{译} 医疗器械辐射灭菌 辐照装置剂量分布测试指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1713-2020 |
Colloidal gold immunochromatography detection kit{译} 胶体金免疫层析法检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0341.2—2020 |
Passive surgical implants - Bone engagement and spinal implants - Part 2: Particular requirements for spinal implants{译} 无源外科植入物 骨接合与脊柱植入物 第2部分：脊柱植入物特殊要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0341.1—2020 |
Passive surgical implants - Bone engaging and spinal implants - Part 1: Particular requirements for bone engaging implants{译} 无源外科植入物 骨接合与脊柱植入物 第1部分：骨接合植入物特殊要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1765-2020 |
Test method of total knee prosthesis restraint{译} 全膝关节假体约束度测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1762-2020 |
Test method for dynamic fatigue performance of metal tibial tray components for unicondylar knee replacement prostheses{译} 单髁膝关节置换假体金属胫骨托部件动态疲劳性能试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1759-2020 |
Guidelines for Design and Evaluation of Primary Flexible Packaging for Medical Devices{译} 医疗器械软性初包装设计与评价指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1758-2020 |
Cardiovascular Implants Pulmonary Valved Tubes{译} 心血管植入物 肺动脉带瓣管道 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1754.2-2020 |
Preclinical animal studies of medical devices Part 2: Rat skin defect model of induced diabetes{译} 医疗器械临床前动物研究 第2部分:诱导糖尿病大鼠皮肤缺损模型 |
China Pharmaceutics Industry Standards |
English PDF |
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