Hi everyone.

I'm new in this forum and in this business.

I'm helping a friend of mine that's creating a new electronic medical device(similar to the equipment that reads and registers a patient's heart beat for a single day, class Ia).

I have three questions:
1. What are the main points that a Product Manual Dossier should have to ensure its conformity and CE marking?
2. To ensure that the equipment is in accordance with the IEc 60601-1, is it enough to have it tested in a laboratory that is accredited to do those tests?
3. Could someone give me a site to get the symbols or examples of symbols to go in conformity with EN 980:2008?

Thanks in advance.

Yours truly

Xixi

Hi everyone.

I'm new in this forum and in this business.

I'm helping a friend of mine that's creating a new electronic medical device(similar to the equipment that reads and registers a patient's heart beat for a single day, class Ia).

I have three questions:
1. What are the main points that a Product Manual Dossier should have to ensure its conformity and CE marking?
2. To ensure that the equipment is in accordance with the IEc 60601-1, is it enough to have it tested in a laboratory that is accredited to do those tests?
3. Could someone give me a site to get the symbols or examples of symbols to go in conformity with EN 980:2008?

Thanks in advance.

Yours truly

Xixi

Welcome to The Cove Forums! :bigwave: :bigwave:

Here is a thread (http://elsmar.com/Forums/showthread.php?t=28211) pertaining to EN 980:2008.

And here is a possible source (http://www.bsigroup.com/en/Shop/Publication-Detail/?pid=000000000030081937) for that standard.

Other (much more knowledgeable) Covers will chime in soon.

Stijloor.

There is no Class 1a. The possible classes are 1, 1-s, 1-m, 2a, 2b, 3. See the Medical Device Directive (MDD) for definitions and the classification procedure.

As a general starting point, the Technical File or Design Dossier (depending on classification) must document the conformance of the device to the Essential Requirements in Annex I of the MDD. The appropriate content will be highly dependent on the nature of the product.

An appropriately certificated lab (i.e. perhaps ISO 17025) can provide a report that will serve as evidence of conformance to a particular standard that is within their testing scope. Have you determined that IEC 60601-1 is the only standard to which your product requires conformance?

EN 980 symbols are merely graphical communication-elements. One decides what the labels, other product information, marketing literature, etc. need to communicate to the customers, product users and other stakeholders based on the characteristics of the product and its use. That determination then drives what symbols are to be used. It would be non-functional to do that the opposite way around.