无源(不带电)医疗器械测试服务 Non-active medical devices Test Services |
有源(带电)医疗器械测试服务 Active medical devices est services | |||||||
服旁项目丨 Testing Services | 服务项目 Testing Services: | |||||||
微生物限度测试(药典) | 无菌测试 | 细种鉴别 | 医疗器械EMC电磁兼容性测试 | 实验室用(体外诊断仪器)电气设备 | ||||
防腐剂的测试 | 生物兼容性测试（ISO 10993） | 电磁兼容性测试 | ||||||
细菌内毒素测试 | 工艺用水的检测分析 | 欧盟IEC/EN 60601医疗器械产品安规和性能测试 | ||||||
化学消毒测试 | 环境监控 | 沉降菌检测 | 专标标准 | 医疗器械性能测试 | ||||
浮游菌检测 | 生物负载测试(ISO 11737) | IEC 62133 CB电池测试 | 无线电及通讯终端测试 | |||||
尘埃粒子检测 | 微粒测试 | 限用物质测试 | ||||||
EMC electromagnetic compatibility testing of medical devices | ||||||||
Microbial Limit Test Pharmacopoeia | Sterilization test | Laboratory (in vitro diagnostic instruments)electrical equipment | ||||||
Species Identify | Preservatives test | Electromagnetic Compatibility Test | ||||||
Biological evaluation of medical devices | Bacterial nendotoxin test | European IEC/EN 60601 medical device product safety and performance testing | ||||||
Process water test and analysis | Chemical disinfection test | Specifically Standards | ||||||
Environment monitoring Services | Setting microbe test | Medical Device Performance Testing | ||||||
Airborne microbe test | Dust particle test | IEC 62133 CB battery test | ||||||
Sterilization of medical devices | Particle test | Radio and Telecommunications Terminal Testing | ||||||
Restricted substance testing services |
残疾人辅助设备、轮和电动代步车 Technical Aids for disabled persons,Wheelchairs and scooters | |||||||
涉及产品 I Related products: | ||||||||
一次性输血、输注器具: 一次性静脉输液针、注射器、输液器、导尿管、次性使用胃导管、一次性使用鼻饲管等。 |
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医用数料天然纱有、合成纤维类数料、多贸类赦料、发泡多爱体类料、水胶体类教料等。 | ||||||||
乳胶产品; 医用乳胶手套、乳胶管、止血带等。 | ||||||||
灭菌及灭菌设备: 医用灭菌袋、医用灭菌器、医用灭菌锅等。 | ||||||||
体外诊断试剂及器械血糖试纸、早孕试纸条、抗生素药敏纸片、尿检试纸丙氨酸氨基转移酶试剂盒、胆固醇试剂盒、体外凝血诊断试剂、甘油三脂检测试剂盒等。 | 在欧盟各成员国中, 残疾人辅助设备、轮椅和电动代步车都受到医疗设备指令(MDD)9342/FC的法规规范。产品必须要满足指令要求才可以在市场上销售。 | |||||||
Disposable transfusion, infusion: disposable infusion needles, syringes, infusion sets, catheters, disposable stomach tube, disposable feeding tubes, etc. Madical dressings: natural gauze, synthetic dressings, poly film dressing polymer foam dressings, hydro colloid dressings, etc. Emulsion products latex gloves, latex tubes, tourniquets, etc. Radio sterilized and sterilization equipment medical sterilization bags, medical sterilizers, medical sterilization pot, etc Outside diagnose reagent and devices: glucose testing strips, pregnancy test strips, antibiotic susceptibility strips, urine strip, alanine aminotransferase kit, cholesterol kit, coagulation in vitro diagnostic reagents, test kits, triglyceride, | In member states of the European Union, technical aids for disabled persons, wheelchairs and scooters are subject to the statutory requirements of the Medical Device Directive 93/42/EEC. These products can only be launched on to the market of their manufactures fulfill these requirements | |||||||
残疾人辅助设备、轮椅和电动代步车类产品涉及标准包括 | ||||||||
Applicable standards for verification: | ||||||||
EN 12182 | EN 12184 | EN 60601 | ||||||
ISO 12183 | EN 7176 | EN/ISO 13485 | ||||||
此类产品涉及的主要测试内容包括 Test items | ||||||||
净态和动态安全稳定性 | 撞击安全 | 速度和测车距离 | ||||||
电气安全 | 加速和减速特性 | 电磁兼容性 | ||||||
强度和耐久性 | 材料分析 | 驾驶性性能 | ||||||
