Testing Laboratories in Europe to IEC/EN 60601-2-47

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Peter Selvey

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#3
#3
Are you just interested in performance tests such as sensitivity/noise/frequency response/input impedance etc (201.12.4 in the 2012 edition), or the database tests (201.12.1, AHA, MIH, EST, etc)?

There is a big difference between the two, Clause 201.12.4 is relatively easy and many labs of the major agencies (TUVs, UL, CSA etc) now have the equipment to do these tests themselves, just need to ask around.

However Clause 201.12.1 is highly specialized and generally done by the manufacturer, the labs would normally exclude or use the manufacturer's data.
 
T

tallu

Involved In Discussions
#4
#4
Performance tests. Any advice? Should manufacturer perform tests inhouse or in test laboratory?

Database tests are easier to perform internally.
 
P

Peter Selvey

Staff member
Moderator
#5
#5
Depends on a lot of things ...

For most modern regulations (Europe, USA, Australia, Canada, Japan etc), in house testing is OK as long as it can stand up to auditor/reviewer checks. Use qualified people, traceable equipment, validated set ups and keep good records and there should be no problem.

Known exceptions are China and Brazil. Brazil will accept reports from accredited labs, China is a bit unclear. There may be forum members with more experience on those countries than me.

If you are looking at product certification (mark on your product), you need to check with the agency what they will accept. Some will accept manufacturer tests without much effort, some will want to witness the tests, and some might prefer to do it themselves.

Lastly there is marketing, some manufacturers prefer a third party lab report as it looks better.
 
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