医疗器械检测 Medical Devices Testing

日期:2024-05-06 点击:57

PTS Testing Service精锐检测机构为医疗器械制造厂商提供全球性解决方案,帮助新医疗器械产品更快进入市场。我们的专业技能为您提高效率及价值。

PTS Testing Service agency offers medical device manufacturers a globally integrated solution to get devices to market faster. can improve the effcicency and value of your operation by combining in one global package the advantages of our worldwide reach. our wide range of accreditations and resources and global expertise.

医疗器械测试服务包括:

无菌测试   细种鉴别  防腐剂的测试   生物兼容性测试  细菌内毒素测试  
工艺用水的检测分析  化学消毒测试   沉降菌检测  浮游菌检测   尘埃粒子检测  
生物负载测试  微粒测试  限用物质测试  医疗器械EMC电磁兼容性测试
欧盟IEC/EN60601医疗器械产品安规和性能测试
Medical devices test services including:
sterilization test
species ldentify
preservatives test
biological evaluation of medical devices
bacterial endotoxin test
process water test and analysis
chemical disinfection test
seting microbe test
airborne microbe test 
dust particle test
sterilization of medical devices
particle test 
restriced substance testing services
EMC electromagnetic compatibility testing of medical devices
European IEC/EN 60601 medical davice product safaty and performance testing

涉及产品 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、一次性使用胃导管等。

医用敷料:天然纱布、合成纤维类敷料、多聚膜类敷料、发泡多聚体类敷料、水胶体类敷料等。

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。

Disposable transfusion, infusionc disposable infusion needies, syringes, infusion sets, catheters, disposable stomach tube, disposable feeding tubes,etc.

Medical dressings: natural gauze, synthetic dressings,poly film dressings, polymer foam dressings, hydrocolloid dressings, etc.

Emulsion products: latex gloves, latex tubes, tourniquets, etc.

Radiosterilized and sterilization aquipment: medical sterilization bags, medical sterilizers, medical sterilization pot, etc.

Uutside diagnose reagent and davices: glucose testing strips, pregnancy test strips, antibiotic suscetibility strips, urine strip, alanine aminotransferase kit, cholesterol kit, coagulation in vitro diagnostic reagents, test kits, triglyceride, etc.


精锐检测机构为全球各地的企业及跨境电商提供合规认证服务, 包括美国CPC认证, FCC认证, FDA注册, UL/CSA/ETL安规报告, 欧盟CE认证,CE-TOY, CE-EMC, CE-LVD, CE-RED,   英国UKCA认证, 加拿大CCPSA认证, 澳大利亚AS/NZS ISO 8124认证;EPR注册, 包装法注册,电池法注册,WEEE注册;RSL Report - Phthalates, SCCP, RoHS, REACH, CPSIA, Ca Prop 65, ASTM F963, EN71, SOR/2011-17, GB 6675, LFGB, FDA, POPs, TSCA, TPCH, PFAS, PAHs;REACH附录17Annex XVII of REACH - 铅镉含量, 镍释放, 甲醛. 偶氮AZO. 致癌致敏染料, 有机锡, 邻苯二甲酸盐, 重金属, 盐雾腐蚀, 高温老化, 成分分析。我们的服务范围包括玩具, 饰品, 手表, 眼镜, 皮革制品, 鞋类, 箱包, 手袋, 服饰, 纺织品, 家具, 灯具, 电子电器, 汽车零部件, 美容化妆品, 护理按摩产品, 成人情趣用品等日常消费类产品。合规认证检测业务联络:陈经理13602386325  杨姑娘18825841124