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
电源TPP30-109A-JTPP30-112A-JTPP30-124A-JIEC /EN/ES 60601- 1第三版 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...
对地电压泄露电流低于200uA,触碰泄露电流低于50µA,达到5,000m工作中海拔高度。 lambda程控电源本产品获得IEC/EN/ES/CSA60601-1,IEC/EN/UL/CSA62368-1安规认证,含有合乎低电压和ROHS2命令的CE标志。合乎EN55011-B与EN55032-B(传输与辐射源),并符合EN61000-3-2谐波电流,IEC60601-1-2第四版与IEC61000-4...
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. ...
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" ...
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