Cart:
| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| YY/T 1702-2020 |
Dentistry Additive Manufacturing Laser Selective Melting of Metal Materials for Oral Immobilization and Removable Restoration{译} 牙科学 增材制造 口腔固定和活动修复用激光选区熔化金属材料 |
China Pharmaceutics Industry Standards |
 English PDF |
| YY/T 1699-2020 |
Tissue Engineering Medical Device Products Chitosan{译} 组织工程医疗器械产品 壳聚糖 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1697-2020 |
Test method for determination of strength and curing time of synthetic water-activated polyurethane fiberglass orthopedic bandages{译} 合成水激活聚氨酯玻璃纤维矫形绷带强度及固化时间测定试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1690-2020 |
Determination method of 2-chloroethanol residue in disposable polyvinyl chloride infusion set{译} 一次性使用聚氯乙烯输注器具中2-氯乙醇残留量测定方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1685-2020 |
Pneumatic pulse oscillating expectoration equipment{译} 气动脉冲振荡排痰设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1680-2020 |
Evaluation of in vivo osteoinductive properties of allogeneic repair material demineralized bone material{译} 同种异体修复材料 脱矿骨材料的体内成骨诱导性能评价 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1653-2020 |
Infusion pump tubing{译} 输液泵用管路 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1182-2020 |
Reagents (boxes) for nucleic acid amplification detection{译} 核酸扩增检测用试剂(盒) |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0809.13-2020 |
Surgical implants - Partial and total hip joint prostheses - Part 13: Determination of torsional moments of fixation of the head of a stemmed femoral component{译} 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 Pharmaceutics Industry Standards |
English PDF |
| YY/T 0734.5-2020 |
Washer-disinfectors - Part 5: Washer-disinfectors for chemical disinfection of non-intrusive medical devices not resistant to high temperatures - Requirements and tests{译} 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 Pharmaceutics Industry Standards |
English PDF |
| YY/T 0513.3-2020 |
Allogeneic Restorative Materials Part 3: Demineralized Bone{译} 同种异体修复材料 第3部分：脱矿骨 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0595-2020 |
Medical Device Quality Management System YY/T 0287-2017 Application Guide{译} 医疗器械 质量管理体系YY/T 0287-2017 应用指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1799—2020 |
Technical requirements for reusable medical protective clothing{译} 可重复使用医用防护服技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0616.5-2019 |
Medical gloves for single use—Part 5:Test method for permeation of chemicals under conditions of continuous contact 一次性使用医用手套 第5部分：抗化学品渗透 持续接触试验方法 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0506.8-2019 |
Surgical drapes,gowns and clean air suits for patients, clinical staff and equipment—Part 8:Special requirements for products 病人、医护人员和器械用手术单、手术衣和洁净服 第8部分：产品专用要求 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 1668—2019 |
Basic Electroacoustic Characteristics and Measurement Methods of Array Pulse-Echo Ultrasonic Transducers{译} 阵列式脉冲回波超声换能器的基本电声特性和测量方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0774—2019 |
Ultrasound bone densitometer{译} 超声骨密度仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1642—2019 |
Disposable medical protective cap{译} 一次性使用医用防护帽 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1633—2019 |
Disposable medical protective shoe cover{译} 一次性使用医用防护鞋套 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1681—2019 |
Basic terms of medical device unique identification system{译} 医疗器械唯一标识系统基础术语 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1670.1—2019 |
Neurotoxicity evaluation of medical devices Part 1: Guidelines for selection of tests for evaluating potential neurotoxicity{译} 医疗器械神经毒性评价 第1部分：评价潜在神经毒性的试验选择指南 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1669—2019 |
ABO reverse typing test card (column agglutination method){译} ABO反定型检测卡(柱凝集法) |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1666—2019 |
Meridian Stimulator{译} 经络刺激仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1665—2019 |
Vibration percussion expectoration machine{译} 振动叩击排痰机 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1664—2019 |
Parathyroid hormone assay kit{译} 甲状旁腺激素测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1661—2019 |
Acupoint impedance detection equipment{译} 穴位阻抗检测设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1660—2019 |
Radial load test method for balloon-expandable and self-expanding vascular stents{译} 球囊扩张和自扩张血管支架的径向载荷测试方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1659—2019 |
General technical requirements for intravascular ultrasound diagnostic equipment{译} 血管内超声诊断设备通用技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1657—2019 |
Preimplantation Chromosomal Aneuploidy Detection Kit (Sequencing Method){译} 胚胎植入前染色体非整倍体检测试剂盒（测序法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1550.2—2019 |
Guidelines for Compatibility Studies of Disposable Infusion Sets and Drugs Part 2: Leachables Studies Known Substances{译} 一次性使用输液器具与药物相容性研究指南 第2部分：可沥滤物研究 已知物 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1465.6—2019 |
Methods for evaluating the immunogenicity of medical devices - Part 6: Determination of animal spleen lymphocyte subsets by flow cytometry{译} 医疗器械免疫原性评价方法 第6部分：用流式细胞术测定动物脾脏淋巴细胞亚群 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1214—2019 |
Human chorionic gonadotropin assay kit{译} 人绒毛膜促性腺激素测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0916.20—2019 |
Small Bore Fittings for Medical Liquids and Gases - Part 20: General Test Methods{译} 医用液体和气体用小孔径连接件 第20部分：通用试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0878.3—2019 |
Complement activation test for medical devices Part 3: Determination of complement activation products (C3a and SC5b-9){译} 医疗器械补体激活试验 第3部分：补体激活产物（C3a和SC5b-9）的测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0870.6—2019 |
Genotoxicity testing of medical devices - Part 6: In vitro mammalian cell micronucleus test{译} 医疗器械遗传毒性试验 第6部分：体外哺乳动物细胞微核试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0870.3—2019 |
Medical device genotoxicity testing Part 3: TK gene mutation testing with mouse lymphoma cells{译} 医疗器械遗传毒性试验 第3部分：用小鼠淋巴瘤细胞进行的TK基因突变试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0639—2019 |
In Vitro Diagnostic Medical Devices Manufacturer's Information for In Vitro Diagnostic Reagents for Biological Staining{译} 体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0506.8—2019 |
Surgical drapes, gowns and cleansers for patients, medical staff and instruments - Part 8: Product specific requirements{译} 病人、医护人员和器械用手术单、手术衣和洁净服 第8部分：产品专用要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1026—2019 |
dentistry dental amalgam{译} 牙科学 牙科银汞合金 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1663—2019 |
Progesterone Assay Kit{译} 孕酮测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1662—2019 |
Quality Controls for Biochemical Analyzers{译} 生化分析仪用质控物 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1658—2019 |
Determination method of cyclohexanone dissolved in blood transfusion apparatus{译} 输液输血器具中环己酮溶出量的测定方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1655—2019 |
Bone engaging implants - Test method for fretting corrosion of bone plates and screws{译} 骨接合植入物 接骨板和接骨螺钉微动腐蚀试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1654—2019 |
Tissue Engineering Medical Device Products Sodium Alginate{译} 组织工程医疗器械产品 海藻酸钠 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1652—2019 |
General technical requirements for quality control substances for in vitro diagnostic reagents{译} 体外诊断试剂用质控物通用技术要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1651.1—2019 |
Hemolysis test for medical devices - Part 1: Material-mediated hemolysis test{译} 医疗器械溶血试验 第1部分：材料介导的溶血试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1649.1—2019 |
Interaction test between medical device and platelets - Part 1: In vitro platelet count method{译} 医疗器械与血小板相互作用试验 第1部分：体外血小板计数法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1648—2019 |
Correlation method between bubble point pressure and bacterial retention capacity of filters for infusion sets{译} 输液器具用过滤器的泡点压与细菌截留能力关联方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1645—2019 |
Human Parvovirus B19 IgG Antibody Detection Kit{译} 人细小病毒B19 IgG抗体检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1626—2019 |
Electric upper and lower limb circular motion training equipment{译} 电动上下肢圆周运动训练设备 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1213—2019 |
Follicle-stimulating hormone assay kit{译} 促卵泡生成素测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1155—2019 |
Automatic Luminescence Immunoassay Analyzer{译} 全自动发光免疫分析仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0870.2—2019 |
Medical device genotoxicity test - Part 2: In vitro mammalian cell chromosomal aberration test{译} 医疗器械遗传毒性试验 第2部分：体外哺乳动物细胞染色体畸变试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0681.16—2019 |
Test methods for packaging of sterile medical devices - Part 16: Test for climatic resilience of packaging systems{译} 无菌医疗器械包装试验方法 第16部分:包装系统气候应变能力试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0573.3—2019 |
Single-use sterile syringes Part 3: Self-destructing fixed-dose vaccine syringes{译} 一次性使用无菌注射器 第3部分：自毁型固定剂量疫苗注射器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0465—2019 |
Disposable hollow fiber plasma separator and plasma fraction separator{译} 一次性使用空心纤维血浆分离器和血浆成分分离器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0448—2019 |
Ultrasound Doppler Fetal Heart Rate Monitor{译} 超声多普勒胎儿心率仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0339—2019 |
Suction catheter for respiratory tract{译} 呼吸道用吸引导管 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0324—2019 |
Infrared Breast Examiner{译} 红外乳腺检查仪 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0174—2019 |
surgical blade{译} 手术刀片 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 1650—2019 |
X-ray image guided radiotherapy equipment performance and test methods{译} X射线图像引导放射治疗设备 性能和试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0585.2—2019 |
Disposable fluid circuits and accessories for pressure infusion equipment - Part 2: Accessories{译} 压力输液设备用一次性使用液路及附件 第2部分：附件 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0585.1—2019 |
Disposable fluid circuits and accessories for pressure infusion equipment - Part 1: Fluid circuits{译} 压力输液设备用一次性使用液路及附件 第1部分:液路 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0286.1—2019 |
Special Infusion Sets Part 1: Disposable Microporous Filter Infusion Sets{译} 专用输液器 第1部分：一次性使用微孔过滤输液器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY 0096—2019 |
Cobalt-60 teletherapy machine{译} 钴-60远距离治疗机 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1628—2019 |
Polyvinyl chloride pellets for medical infusion and blood transfusion equipment{译} 医用输液、输血器具用聚氯乙烯粒料 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1683-2019 |
Dentistry Osteotomy{译} 牙科学 牙骨凿 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1682-2019 |
Ureaplasma/Mycoplasma hominis culture and drug susceptibility detection kit{译} 脲原体/人型支原体培养及药物敏感检测试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1646-2019 |
Dentistry - Test methods for determining the x-ray resistance of materials{译} 牙科学 测定材料的X射线阻射性试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1689-2019 |
Dentistry Labeling systems for dental implants{译} 牙科学 牙种植体的标示系统 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1687-2019 |
Boiling Sterilizer{译} 煮沸消毒器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1678-2019 |
Method for detecting the molecular weight and molecular weight distribution of polylactic acid and its copolymers for surgical implants{译} 外科植入物用聚乳酸及其共聚物分子量及分子量分布检测方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1677-2019 |
Vitamin B12 Assay Kit (Label Immunoassay){译} 维生素B12测定试剂盒（标记免疫分析法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1675-2019 |
Serum electrolytes (potassium, sodium, calcium, magnesium) reference measurement procedure (ion chromatography){译} 血清电解质（钾、钠、钙、镁）参考测量程序（离子色谱法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1674-2019 |
Insulin-like growth factor I assay kit{译} 胰岛素样生长因子I测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1673-2019 |
Amphetamine detection kit (colloidal gold method){译} 安非他明检测试剂盒（胶体金法） |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1672-2019 |
Pepsinogen I/II Assay Kit{译} 胃蛋白酶原I/II测定试剂盒 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1649.2-2019 |
Medical device and platelet interaction test Part 2: Determination of platelet activation products (β-TG, PF4 and TxB2) in vitro{译} 医疗器械与血小板相互作用试验 第2部分：体外血小板激活产物（β-TG、PF4和TxB2）的测定 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1647-2019 |
joint replacement implants shoulder prostheses test method for static shear evaluation of glenoid locking mechanisms{译} 关节置换植入物 肩关节假体 关节盂锁定机制的静态剪切评价试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1638.1-2019 |
Patient handling equipment - Part 1: Ambulance stretchers{译} 病人搬运设备 第1部分：救护车担架 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 1624-2019 |
Manual negative pressure cupping device{译} 手动负压拔罐器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0719.8-2019 |
Ophthalmic optics - Contact lens care products - Part 8: Determination of cleaning agents{译} 眼科光学 接触镜护理产品 第8部分：清洁剂测定方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0681.17-2019 |
Test methods for packaging of sterile medical devices - Part 17: Microbial barrier testing by aerosol filtration for breathable packaging materials{译} 无菌医疗器械包装试验方法 第17部分：透气包装材料气溶胶过滤法微生物屏障试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0681.15-2019 |
Sterile medical device packaging test methods - Part 15: Performance testing of shipping containers and systems{译} 无菌医疗器械包装试验方法 第15部分：运输容器和系统的性能试验 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0616.5-2019 |
Disposable medical gloves - Part 5: Resistance to chemical penetration - Continuous exposure test method{译} 一次性使用医用手套 第5部分：抗化学品渗透 持续接触试验方法 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0513.1-2019 |
Allogeneic prosthetic materials Part 1: Basic requirements for tissue banks{译} 同种异体修复材料 第1部分：组织库基本要求 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0464-2019 |
single-use hemoperfusion device{译} 一次性使用血液灌流器 |
China Pharmaceutics Industry Standards |
English PDF |
| YY/T 0616.4-2018 |
Medical glove for single use—Part 4:Test method for the puncturation resistance 一次性使用医用手套 第4部分：抗穿刺试验方法 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0616.3-2018 |
Medical gloves for single use—Part 3:Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions 一次性使用医用手套 第3部分：用仓贮中的成品手套确定实际时间失效日期的方法 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 0506.4-2016 |
Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 4:Test method for linting in the dry state 病人、医护人员和器械用手术单、手术衣和洁净服第4部分：干态落絮试验方法 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY/T 1497-2016 |
Evaluation test method for the viral filtration efficiency(VFE)of medical protective face mask materials—Test method using Phi-X174 bacteriophage 医用防护口罩材料病毒过滤效率评价测试方法 Phi-X174噬菌体测试方法 |
China YY-Medicine & Medical Device Industry Standards |
English PDF |
| YY 1413-2016 |
Centrifugal blood components separation device 离心式血液成分分离设备 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1412-2016 |
Cardiopulmonary bypass systems-Centrifugal pump 心肺转流系统离心泵 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1301-2016 |
(Laser therapy equipment erbium laser treatment) 激光治疗设备铒激光治疗机 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1300-2016 |
(Laser therapy equipment Pulse Nd YAG laser treatment) 激光治疗设备脉冲掺钕钇铝石榴石激光治疗机 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1298-2016 |
(Medical endoscope capsule endoscope) 医用内窥镜胶囊式内窥镜 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1296-2016 |
(Optics and photonics surgical microscope ophthalmic surgical microscope light hazard) 光学和光子学手术显微镜眼科用手术显微镜的光危害 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1290-2016 |
Single use bilirubin plasma hemoperfutor 一次性使用胆红素血浆吸附器 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1289-2016 |
(Laser therapy equipment ophthalmic semiconductor laser photocoagulation instrument) 激光治疗设备眼科半导体激光光凝仪 |
China Medicine & Medical Device Standards |
English PDF |
| YY 1282-2016 |
Intravenous catheter for single use 一次性使用静脉留置针 |
China Medicine & Medical Device Standards |
English PDF |
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