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

[tallu]

Any recommendation where to test device against IEC/EN 60601-2-47?

Does someone knows any test lab in Europe?

 

[Stijloor]

A Quick Bump!

Can someone help??

Thank you very much!!

 

[Peter Selvey]

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.

 

[tallu]

Performance tests. Any advice? Should manufacturer perform tests inhouse or in test laboratory?

Database tests are easier to perform internally.

 

[Peter Selvey]

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.

 

[tallu]

Is there any clear form or template available to document the testing?

 

[Pads38]

Is there any clear form or template available to document the testing?

Yes - search the IEC webstore and you will find an associated TRF (test report form).

http://webstore.iec.ch/webstore/web...form&key=60601-2-47&sorting=&start=1&onglet=1

 

[DMichael]

Very helpful! Is in-house testing still OK for new 60601-2-47 applications? Do you think any certifications/accreditations would be required?

 

[Peter Selvey]

There's always going to be standards like IEC 60601-2-47 which are difficult, rarely requested and subjective, so it's not economical for third party labs to be set up for. As such, modern regulations will never insist that accredited testing is required. However, agencies (e.g. Notified Bodies, auditors) may imply that third party testing is required, but really that's just a preference to make their life easier. If it's accredited, they can just record the report number, testing agency etc and move on. If it's not, they (should) check the detail in the reports, qualifications of persons doing, equipment is calibrated, raw data, completeness etc etc etc, which is a lot of work.

Some regulations (Brazil? China?) might insist on third party testing. However, this would be lip service only. Most labs are not set up so if a report existed it would be some form of a fudge, or detail would show the lab didn't really do the testing.

 

[DMichael]

Thank you so much for sharing your insight on this!