Combining IEC 60601-1 certified ME equipment into an ME system

[k3000]

I am looking to produce an ME system which uses 2 separate pieces of ME equipment that have already been 60601-1 certified individually by different manufacturers. I need to understand whether a full suite of 60601-1 testing will be required for the new medical device.

 

[FelipeSchneider]

I would say that a full suite 60601-1 is definitely necessary. I can imagine many different situations where the device can fail only considering the IEC 60601-1-2 standard such as:
- Irradiance emissions
- Conducted emissions
...

For the 60601-1 I would mention:
- Leakage current
- Insulation levels
...

 

[emceng]

IEC 60601-1-2 will require full testing. I am not an expert on 60601-1 safety, but my understanding is that at minimum you need to do an evaluation. You or your test lab can use data from the previous testing to determine compliance, but there may be gaps that need to be filled by testing the system as a while.