电子血压计做FDA认证需要测试那些项目以及准备什么资料
各位大侠，小虾，同学们。有谁知道电子血压计做FDA需要做哪些测试项目，还要准备什么资料？
回答有奖！ Generally, it includes two test requirements, say, Non-clinical tests and Clinical test;
For non-clinical test, the sphygmoomanometer shall be verified acc. to below standards
1 .Electrical safety:IEC 60601-1 or UL 60601-1
2. EMC: IEC 60601-1-2
3. FCC : FCC part 15
4. safety and performance characteristics: ANSI/AAMI SP10
For Clinical test,
In compliance with the essential requirements of ANSI/AAMI SP10.
Hope it helps a bit! 楼上的只说了检测方面的要求，当然检测还有ISO10993要做，另外更重要的是要提交510K文档。类似于技术文件的东西，工程比较浩大。
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