Standard Code | Standard Title | Standard Class | Order |
---|---|---|---|
YY/T 9706.106-2021 |
Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Availability {译} 医用电气设备 第1-6部分:基本安全和基本性能的通用要求 并列标准:可用性 |
China Pharmaceutics Industry
Standards Medical |
English PDF |
YY 9706.102-2021 |
Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility Requirements and Tests {译} 医用电气设备 第1-2部分:基本安全和基本性能的通用要求 并列标准:电磁兼容 要求和试验 |
China Pharmaceutics Industry
Standards Medical |
English PDF |
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 Medical |
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 Medical |
English PDF |
YY/T 1757-2021 |
Medical freezer {译} 医用冷冻保存箱 |
China Pharmaceutics Industry
Standards Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
SF/T 0097-2021 |
Guidelines for Forensic Identification of Medical Injury{译} {译} 医疗损害司法鉴定指南 |
China Judicial industry
Standards Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
YY/T 0953—2020 |
Medical carboxymethyl chitosan {译} 医用羧甲基壳聚糖 |
China Pharmaceutics Industry
Standards Medical |
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 Medical |
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 Medical |
English PDF |
JB/T 14007-2020 |
Rolling Bearings Medical X-ray Tube Coupling Bearings and Units {译} 滚动轴承 医用X射线管联轴轴承及其单元 |
China Machinery Industry
Standards Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
HJ 1105-2020 |
Technical Specifications for Pollution Discharge Permit Application and Issuance Medical Institutions {译} 排污许可证申请与核发技术规范 医疗机构 |
China Environment Industry
Standards Medical |
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 Medical |
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 Medical |
English PDF |
YY/T 0086-2020 |
Medical refrigerator {译} 医用冷藏箱 |
China Pharmaceutics Industry
Standards Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
YS/T 650-2020 |
Seamless copper tubing for Medical gases and vacuum {译} 医用气体和真空用无缝铜管 |
China Non-ferrous Metal Industry
Standards Medical |
English PDF |
JT/T 1366—2020 |
Emergency Medical support requirements for diving operations {译} 潜水作业应急医疗保障要求 |
China Transport Industry
Standards Medical |
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 Medical |
English PDF |
WS 76-2020 |
Specification for quality control and testing of Medical X-ray diagnostic equipment {译} 医用X射线诊断设备质量控制检测规范 |
China Hygiene Industry
Standards Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
FZ/T 64063-2017 |
Medical elastic base fabric 医用贴弹性基布 |
China Textile & Garment industry
Standards Medical |
English PDF |
HG/T 4127-2017 |
(Medical dry film) 医用干式胶片 |
China Chemical Industry
Standards Medical |
English PDF |
WS/T 535—2017 |
On-site rapid detection method of commonly used disinfectants in Medical and health institutions{译} {译} 医疗卫生机构常用消毒剂现场快速检测方法 |
China Hygiene Industry
Standards Medical |
English PDF |
JJG 581-2016 |
(Medical laser source verification procedures) 医用激光源检定规程 |
China Metrological
Standards Medical |
English PDF |
JT/T 1082-2016 |
(Air Diving Medical Support Requirements) 空气潜水医学保障要求 |
China Highway & Transportation
Standards Medical |
English PDF |
JR/T 0147-2016 |
(Insurance companies participate in social Medical insurance service data exchange specification) 保险公司参与社会医疗保险服务数据交换规范 |
China Finance
Standards Medical |
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 Medical |
English PDF |
HJ 794-2016 |
Technical guidelines for environmental protection in Medical organization for check and accept of completed project 建设项目竣工环境保护验收技术规范医疗机构 |
China Environmental Protection Industry
Standards Medical |
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 Medical |
English PDF |
YY/T 1406.1-2016 |
Medical device software—Part 1:Guidance on the application of YY/T 0316 to medical device software 医疗器械软件 第1部分:YY/T0316应用于医疗器械软件的指南 |
China YY-Medicine & Medical Device Industry
Standards Medical |
English PDF |
YY/T 1402-2016 |
(Medical devices steam sterilization process challenge device applicability of test methods) 医疗器械蒸汽灭菌过程挑战装置适用性的测试方法 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1307-2016 |
(Medical breast X-ray photography with digital detectors) 医用乳腺数字化x射线摄影用探测器 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1276-2016 |
(Development of Medical devices dry heat sterilization process, validation and routine control) 医疗器械干热灭菌过程的开发、确认和常规控制要求 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1146-2016 |
(Medical optical instruments illuminance test methods) 医用光学仪器照度测试方法 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0976-2016 |
(Medical electrical equipment - radiotherapy ionization chamber dosimeter) 医用电气设备放射治疗用电离室剂量计 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0972-2016 |
(Active implantable Medical devices implanted pacemaker device with a four-pole connector system size and test requirements) 有源植入医疗器械植入式心律调节设备用四极连接器系统尺寸和试验要求 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0481-2016 |
(Medical Diagnostic X-ray equipment with radiation characteristic measurement conditions) 医用诊断x射线设备测定特性用辐射条件 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0291-2016 |
(Medical X-ray equipment environmental requirements and test methods) 医用x射线设备环境要求及试验方法 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0079-2016 |
(Medical metal clip) 医用金属夹 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0064-2016 |
(Medical Diagnostic X-ray tube assembly and the electrical load characteristics) 医用诊断x射线管组件电气及负载特性 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0043-2016 |
(Medical suture needle) 医用缝合针 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY 1468-2016 |
Oxygen concentrator supply systems for use with Medical gas pipeline systems 用于医用气体管道系统的氧气浓缩器供气系统 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY 1057-2016 |
Genral specifications for Medical foot switch 医用脚踏开关通用技术条件 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY 0989.6-2016 |
(Requirements for the treatment of tachyarrhythmia of active implantable Medical devices (including implantable defibrillators): The surgical implant of active implantable medical devices - Part 6) 手术植入物有源植入医疗器械 第6部分:治疗快速性心律失常的有源植入医疗器械(包括植入式除颤器)的专用要求 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY 0299-2016 |
Medical ultrasonic couplants 医用超声耦合剂 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1474-2016 |
(Medical Device Usability engineering applications for medical devices) 医疗器械可用性工程对医疗器械的应用 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1473-2016 |
(Standards of Medical equipment standardization guide covers safety requirements) 医疗器械标准化工作指南涉及安全要求的标准制定 |
China Medicine & Medical Device
Standards Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
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 Medical |
English PDF |
FZ/T 64063-2016 |
(Medical sticky elastic fabric) 医用贴弹性基布 |
China Textile & Garment industry
Standards Medical |
English PDF |
SN/T 1422-2015 |
(Entry and exit control standards for aircraft Medical vectors) 入出境航空器医学媒介生物控制标准 |
China Import Export Inspection
Standards Medical |
English PDF |
HG/T 4866-2015 |
Non-silver digital Medical image ink-jet blue film 非银数字化医疗影像喷墨蓝胶片 |
China Chemical Industry
Standards Medical |
English PDF |
SN/T 4279-2015 |
(Border crossings Medical vector DNA barcoding insect laboratory practice) 国境口岸医学媒介昆虫dna条形码鉴定实验室管理规范 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4278-2015 |
(Border crossings insect vector DNA barcoding Medical Practice) 国境口岸医学媒介昆虫dna条形码鉴定操作规程 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4271.4-2015 |
(International ships carrying Medical vector collection methods - Part 4: cockroach) 国际航行船舶携带医学媒介生物采集方法 第4部分:蜚蠊 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4271.3-2015 |
(International ships carrying Medical vector collection methods - Part 3: Rodent) 国际航行船舶携带医学媒介生物采集方法 第3部分:鼠类 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4271.2-2015 |
(International ships carrying Medical vector collection methods - Part 2: Flies) 国际航行船舶携带医学媒介生物采集方法 第2部分:蝇类 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4271.1-2015 |
(International ships carrying Medical vector collection methods - Part 1: Mosquitoes) 国际航行船舶携带医学媒介生物采集方法 第1部分:蚊类 |
China Import Export Inspection
Standards Medical |
English PDF |
JJF 1518-2015 |
Calibration Specification for Medical Ultrasonic Field Measurement Systems 医用超声声场测量系统校准规范 |
China Metrological
Standards Medical |
English PDF |
YY 0953-2015 |
Medical carboxymethylchitosan 医用羧甲基壳聚糖 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY 0952-2015 |
Temperature control blanket for Medical use 医用控温毯 |
China Medicine & Medical Device
Standards Medical |
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 Medical |
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 Medical |
English PDF |
YY/T 0921-2015 |
Medical absorbent viscose wadding 医用吸水性粘胶纤维 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0879.2-2015 |
Test for hypersensitivity of Medical devices. Part 2:Marine Local Lymph Node Assay (LLNA): BrdU-ELISA method 医疗器械致敏反应试验 第2部分:小鼠局部淋巴结试验(llna)brdu-elisa法 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0878.2-2015 |
Test for complement activation of Medical devices. Part 2: Serum alternative pathway complement activation 医疗器械补体激活试验 第2部分:血清旁路途径补体激活 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0771.4-2015 |
Medical devices utilizing animal tissues and their derivatives. Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes 动物源医疗器械 第4部分:传播性海绵状脑病(tse)因子的去除和/或灭活及其过程确认分析的原则 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0468-2015 |
Medical devices. Quality management. Medical device nomenclature data structure 医疗器械 质量管理 医疗器械术语系统数据结构 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0466.2-2015 |
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2: Symbol development, selection and validation 医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分:符号的制订、选择和确认 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1297-2015 |
Medical endoscope. Endotherapy device. Curette 医用内窥镜 内窥镜器械 刮匙 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1295-2015 |
Biological evaluation of Medical devices. Nanomaterial: Endotoxin test 医疗器械生物学评价 纳米材料:细菌内毒素试验 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1292.2-2015 |
Test for reproductive and developmental toxicity of Medical devices. Part 2:Prenatal developmental toxicity test 医疗器械生殖和发育毒性试验 第2部分:胚胎发育毒性试验 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1292.1-2015 |
Test for reproductive and developmental toxicity of Medical devices. Part 1:Screening test 医疗器械生殖和发育毒性试验 第1部分:筛选试验 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1278-2015 |
Measuring methods for beam area of Medical ultrasound equipment transducer 医用超声设备换能器声束面积测量方法 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1267-2015 |
Evaluation of materials of Medical device subject to ethylene oxide sterilization 适用于环氧乙烷灭菌的医疗器械的材料评价 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1266-2015 |
Evaluation of materials of Medical device subject to hydrogen peroxide sterilization 适用于过氧化氢灭菌的医疗器械的材料评价 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1265-2015 |
Evaluation of materials of Medical device subject to moist heat sterilization 适用于湿热灭菌的医疗器械的材料评价 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1264-2015 |
Evaluation of materials of Medical device subject to ozone sterilization 适用于臭氧灭菌的医疗器械的材料评价 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1263-2015 |
Evaluation of materials of Medical device subject to dry heat sterilization 适用于干热灭菌的医疗器械的材料评价 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 1084-2015 |
Measurement methods of ultrasonic output power for Medical diagnostic ultrasonic equipments 医用超声诊断设备声输出功率的测量方法 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0995-2015 |
Medical devices for human assisted reproductive technology. Terminology and definitions 人类辅助生殖技术用医疗器械 术语和定义 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0330-2015 |
Medical absorbent cotton 医用脱脂棉 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0308-2015 |
Medical sodium hyalurouate gel 医用透明质酸钠凝胶 |
China Medicine & Medical Device
Standards Medical |
English PDF |
SN/T 4166-2015 |
(Medical vector morphological identification of proficiency testing specification) 医学媒介生物形态学鉴定能力验证规范 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4159.1-2015 |
(International Association for Medical Assistance travelers (IAMAT) designated outpatient medical service standards) 国际旅行者医疗救助协会(iamat)定点门诊医疗服务标准 |
China Import Export Inspection
Standards Medical |
English PDF |
SN/T 4088-2015 |
(Entry and exit of personnel Medical advice Specification) 入出境人员医学咨询规范 |
China Import Export Inspection
Standards Medical |
English PDF |
JJG 1101-2014 |
Verification Regulation of Medical Diagnostic X-ray Source for Dental Panorama 医用诊断全景牙科X射线辐射源检定规程 |
China Metrological
Standards Medical |
English PDF |
JJF 1474-2014 |
Calibration Specification for Non-invasive X-ray Tube Voltage Meters Used in Medical Diagnosis 医用诊断X射线非介入式管电压表校准规范 |
China Metrological
Standards Medical |
English PDF |
JJF 1473-2014 |
Calibration Specification for Medical Diagnostic X-ray Non-invasive Current Meters 医用诊断X射线非介入电流仪校准规范 |
China Metrological
Standards Medical |
English PDF |
JJG 1098-2014 |
Verification Regulation of Medical Syringe Pump and Infusion Pump Analyzers 医用注射泵和输液泵检测仪检定规程 |
China Metrological
Standards Medical |
English PDF |
SN/T 4016-2014 |
(Import and export of textile quality conformity assessment methods special textiles Medical textiles) 进出口纺织品质量符合性评价方法 特种纺织品 医用纺织品 |
China Import Export Inspection
Standards Medical |
English PDF |
YY/T 0931-2014 |
Medical endoscopes. Endotherapy device. Loop ligature 医用内窥镜 内窥镜器械 圈形套扎装置 |
China YY-Medicine & Medical Device Industry
Standards Medical |
English PDF |
YY/T 0968.2-2014 |
Medical optical radiation protective eyewears. Evaluation method. Part 2: Vision and color vision 医用光辐射防护镜 评价方法 第2部分:视明觉和色觉 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0968.1-2014 |
Medical light radiation protective eyewears. Evaluation method. Part 1:Decrease of light hazard 医用光辐射防护镜的评价方法 第1部分:光辐射危害降低程度 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0955-2014 |
Medical endoscopes. Endoscope surgical equipment. Shaver 医用内窥镜 内窥镜手术设备 刨削器 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0944-2014 |
Medical endoscopes. Endotherapy device. Separating forceps 医用内窥镜 内窥镜器械 分离钳 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0943-2014 |
Medical endoscopes. Endotherapy device. Needle forceps 医用内窥镜 内窥镜器械 持针钳 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0941-2014 |
Medical endoscopes. Endotherapy device. Punch forceps 医用内窥镜 内窥镜器械 咬切钳 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0940-2014 |
Medical endoscopes-Endotherapy device. Grasping forceps 医用内窥镜 内窥镜器械 抓取钳 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0934-2014 |
Dynamic digital Medical X-ray image detectors 医用动态数字化X射线影像探测器 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0933-2014 |
Digital Medical X-ray image detector used in general radiography 医用普通摄影数字化X射线影像探测器 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0932-2014 |
Medical luminaries. Medical head-mounted luminaires 医用照明光源 医用额戴式照明灯 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0931-2014 |
Medical endoscopes. Endotherapy device. Loop ligature 医用内窥镜 内窥镜器械 圈形套扎装置 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0930-2014 |
Medical endoscopes. Endotherapy device. Cytology brush 医用内窥镜 内窥镜器械 细胞刷 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0929.1-2014 |
Sterilizing-grade filters for Medical infusion equipments. Part 1:Integrity test for fluid filters. 输液用除菌级过滤器 第1部分:药液过滤器完整性试验 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0927-2014 |
Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC Medical devices 聚氯乙烯医疗器械中邻苯二甲酸二(2-乙基己基)酯(DEHP)溶出量测定指南 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0926-2014 |
Quantitative analysis of DEHP in PVC Medical devices 医用聚氯乙烯医疗器械中邻苯二甲酸二(2-乙基己基)酯(DEHP)的定量分析 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0922-2014 |
Medical endoscopes. Endoscope accessories. Bridges 医用内窥镜 内窥镜附件 镜桥 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0870.5-2014 |
Test for genotoxicity of Medical devices. Part 5: Mammalian bone marrow chromosome aberration test 医疗器械遗传毒性试验 第5部分:哺乳动物骨髓染色体畸变试验 |
China Medicine & Medical Device
Standards Medical |
English PDF |
YY/T 0870.4-2014 |
Test for genotoxicity of Medical devices. Part 4:Mammalian bone marrow erythocyte micronucleus test 医疗器械遗传毒性试验 第4部分:哺乳动物骨髓红细胞微核试验 |
China Medicine & Medical Device
Standards Medical |
English PDF |
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