EN 55011:1998 +A1:1999 +A2:2002 vs. EN55011:2009 Test Levels - Medical Devices

qu1nn said:

Hello,

Is there any change in the test levels from EN 55011:1998 +A1:1999 +A2:2002 to EN55011:2009 which would require re-testing for a Group 1 Class B Medical Device?

Thanks for your time
qu1nn

Click to expand...

Can anyone help?

Thank you very much.

Stijloor.

I´m just giving another bump here. Althougu there´s seem to be only a few medical device EMC experts here on the Cove, they do exist, but might take a while to answer.

Just to make things clear, EN 55011 is the european version of CISPR 11 which is used as a normative reference in IEC 60601-1-2, right?

qu1nn said:

Hello,

Is there any change in the test levels from EN 55011:1998 +A1:1999 +A2:2002 to EN55011:2009 which would require re-testing for a Group 1 Class B Medical Device?

Thanks for your time
qu1nn

Click to expand...

EN 55011 is the European edition of CISPR 11.
The EN 55011:2009 is not listed in the Ofiicial Journal of the European Union yet. This version is identical with the ed. 5 of CISPR 11(2009-05).


There is no difference between the old CISPR 11 / EN 55011 and the new for your type of equipment, no re-test necessary.

Maybe I am just slow, but I am continuously struggling with the language of the Europa site with expiration dates of specifications. So can someone confirm if I am looking at the dates incorrectly for the EN 55011

from this site:


I am seeing the following:

Specification, Expires on
EN 55011:1998 + A1:1999 +A2:2002, expires Nov 1, 2009
EN 55011:2007, expires Sept 1, 2012
EN 55011:2007 + A2:2007, expires Sept 1, 2012
EN 55011:2009 expires, July 1, 2013
EN 55011:2009 + A1:2010, unknown expiration



Thanks for your time
qu1nn

The 'Normative' reference in EN60601-1-2:2007 is an undated reference to CISPR 11 - that means the latest version of CISPR 11 is the one to use.

What is the relationship between IEC60601-1-2 and EN55011?

EN 55011 (CISPR 11) is a reference standard for EN 60601-1-2 (IEC 60601-1-2) for emission test, there are also other reference standards for EN 60601-1-2 (IEC 60601-1-2) for emission test , such as EN 55015 (CIRPR 15), EN 55014-1 (CISPR 14-1) and EN 55022 (CISPR 22). User of EN 60601-1-2 (IEC 60601-1-2) should indendify which standard to follow depending on the technique used by EUT.