Does my Product (Active Machine Support Frame) require CE Marking

[antena]

Hello
Can anyone advice me if the CE mark is required for active machine support frame.
This type of support frames are built partly of electrical and pneumatic components
Below some details:

-system pneumatic pressure: 6 bar
-supply should be 6 bar or higher
-voltage supply is 230V alternating current 1000VA
- Our system works at several different DC voltages ranging from 5V to a maximum of 84V

It is an active isolation system with a suspended machine support frame on a low suspension frequency (3 Hz) that is actively controlled by means of an embedded computer and voice coil actuators.



Rgds, antena

[Alexisss]

Is this used SPECIFICALLY for medical purpose? Is this used SPECIFICALLY with another medical device? Or is it used for other purposes as well, and it can also be used for a medical purpose.

You need to give us more details...

[Ronen E]

In Reply to Parent Post by antena

Hello
Can anyone advice me if the CE mark is required for active machine support frame.
This type of support frames are built partly of electrical and pneumatic components
Below some details:

-system pneumatic pressure: 6 bar
-supply should be 6 bar or higher
-voltage supply is 230V alternating current 1000VA
- Our system works at several different DC voltages ranging from 5V to a maximum of 84V

It is an active isolation system with a suspended machine support frame on a low suspension frequency (3 Hz) that is actively controlled by means of an embedded computer and voice coil actuators.



Rgds, antena

I'm not sure what the thing exactly is, but involving 6 bar pneumatics and 230V AC I'd risk and say - yes, it most likely would require CE marking.

A definite answer would require a closer study of the various EC legislative instruments (directives, regulations etc.) that may apply.

Cheers,
Ronen.

[Alexisss]

Well for sure it will not be a "medical device CE", you may check the machinery directive http://ec.europa.eu/enterprise/secto...ion/machinery/ which I am almost sure you must comply with (and hence be certified).

[CharlieUK]

The Machinery Directive will almost certainly apply, but it's unlikely that you'll need to be "certified" to it - most equipment (unless listed in Annex IV) requires assessment against Essential Health and Safety requirements of Annex I - this can be done by manufacturer, often with help from a test house for specific tests and/or for assistance with the Annex I assessment.