咨询请联系13534239375 。医械去往欧盟国家,取得CE认证即可销售,其测试标准为EN 60601-1,60601-1-2,61010-2-101,61326-1等通用标准以及其它涉及到的标准;美国市场是由FDA管控,测试标准为IEC 60601-1,60601-1
We provide IEC 60601-1 and IEC 61010-1 device testing and regulatory compliance to speed medical devices & laboratory equipment to market.
When doing safety testing according to IEC60950-1 and IEC60601-1, are there big differences in the practical process at the test laboratories? For those test engineers who do both standards, what are the similarities and what are the biggest differences. Thanks. Best regards Amund - --- Thi...
根据IEC /EN/ES 60601- 1第三版,在5000米的操作度上,TPP 30交流/直流电源的特点是一个加固的双I / O系统。漏电电流低于100μA使单位适合的男朋友(身体漂浮)应用程序。91.5%的能在包装格式1.36“x 3.34”中提供。满载工作温度范围涵盖-40°C + 63°C,而上升到85°C负载降额的5。本单位按iec60601-1-2...
Agree with Brian in his YAID [Yet Another It Depends] But if you are in the real scope of IEC 60601 series standards that also means you will have a regulatory submission to the likes of FDA, Health Canada, EU Notified Bodies, etc. There is a lot more overhead for these regulatory ...
Hello IEC 60601-1-2 allows testing of conducted and radiated emissions to CISPR 11; CISPR 14-11; CISPR 32. Concerning the use of CISPR 32: According to Clause 7.1.1 General: "Unless otherwise specified herein, ME EQUIPMENT and ME SYSTEMS shall comply with CISPR 11" ...