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。