EN (IEC) 60601-1 ? Is in-house testing definitely OK?

EN (IEC) 60601-1 – Is in-house testing definitely OK?

I’ve looked at:

IEC/AAMI/ANSI 60601-1:2005 Checklist

But I am still unsure whether or not in-house testing to EN (IEC) 60601-1 would be acceptable i.e. to a NB? I am not covering any EMC testing (i.e. 60601-1-2) this would be done by a test house. Considering the device I have in mind (low voltage DC powered), most of the testing is N/A. As an example of lot of N/A clauses I found this test report on the net:

https://www.medi-flowery.com/publikacje/Rapport IEC60601_1.pdf

Any test equipment etc used would be externally calibrated etc to traceable standards.

Other (in-house) testing that is specific to a particular device e.g. to a harmonised (EU) standard (as part of Essential Requirements), has been acceptable to a NB, so why not 60601-1? The only problem seems to be the published TRF, but I do not see why I cannot create my own form based on the standard.

Any further thoughts?

Steve

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

The company I work for has always done in-house testing for 60601-1, which our Notified Body has never questioned.

Test report forms have been created from the text of the standard for both Edition 2 and now Ed 3. If you were to go on and use a test house to get an 'official mark' your completed in-house test report would significantly reduce the number of questions they would have to ask - all those clauses that have 'check the risk management file' could be answered there.

We have developed simple ways of completing nearly all the tests. For instance, we have not felt it necesary to apply the humidity pre-conditioning as our devices do not have any parts that would absorb moisture so we can be confident that the results would not be affected. Mechanical strength tests are accomplished with weight sets bought from Argos. Drop tests onto hardwood are done onto my kitchen chopping board. Our 'Impact Ball' comes from a boule set.

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

Firstly, as an MDD auditor I have seen many cases of in-house testing.

Secondly, requiring 3rd party testing for EN 60601-1 would set a precedent that cannot be followed for all applicable standards. In other words, you cannot say that some standards must be 3rd party tested without requiring it for all standards.

What an (good) NB auditor should be able to do is confirm if the in-house tests are reasonably competent. Since EN/IEC 60601-1 is relatively specialized, and only a small part of the overall design considerations, most manufacturers do not have the in house experience. So outsourcing to a 3rd party lab makes sense.

Also, there is the problem that most NBs cannot afford to send (truly) qualified technical auditors to the audit site, so the NB would prefer to see test reports from 3rd parties over in-house testing. You might complain about this, but if you stop and think about it, it is really impossible to have an auditor really qualified for all the technology aspects in a single medical device (performance, EMC, electrical safety, functional safety etc etc).

Upshot is: best to use a 3rd party lab unless the size of your company justifies investment in a competent internal test lab.

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

Peter Selvey said:

Firstly, as an MDD auditor I have seen many cases of in-house testing.

Secondly, requiring 3rd party testing for EN 60601-1 would set a precedent that cannot be followed for all applicable standards. In other words, you cannot say that some standards must be 3rd party tested without requiring it for all standards.

What an (good) NB auditor should be able to do is confirm if the in-house tests are reasonably competent. Since EN/IEC 60601-1 is relatively specialized, and only a small part of the overall design considerations, most manufacturers do not have the in house experience. So outsourcing to a 3rd party lab makes sense.

Also, there is the problem that most NBs cannot afford to send (truly) qualified technical auditors to the audit site, so the NB would prefer to see test reports from 3rd parties over in-house testing. You might complain about this, but if you stop and think about it, it is really impossible to have an auditor really qualified for all the technology aspects in a single medical device (performance, EMC, electrical safety, functional safety etc etc).

Upshot is: best to use a 3rd party lab unless the size of your company justifies investment in a competent internal test lab.

Click to expand...

Hello every body,

If a manufacturer decides to follow Annex II of MDD 93/42/EEC as an assessment procedure then what should be the qualification of 3rd Party Lab? Can it be any lab having competency to test the product under the desired standard like EN 60601-1 and/or 60601-2-2? Or is there any requirement for accredited lab as is in case of Annex III?

Muhammad

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

There is no specific requirement for a third party to accredited, if you are using Annex II.

Under Annex II, Section 3.2, there are references to the quality of design, methods to monitor quality of design, and a direct reference to the use of traceable measurements for tests (see 3.2 (e)). Also, under ISO 13485, you need to control outsourced processes, and verify the quality of subcontractors.

So, you will need evidence the lab is competent and has traceability to meet these requirements. Accreditation is one way but not the only way.

Which is a rather interesting subject for IEC 60601-2-2, e.g. measurements of high voltage, current and power at 400kHz. I would expect most test labs won't have traceability if you ask them directly. National standards labs usually only provide traceability to 1kHz for any measurement involving a divider or transformer (e.g. high voltage, high current). Good luck!

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

Peter Selvey said:

There is no specific requirement for a third party to accredited, if you are using Annex II.

Under Annex II, Section 3.2, there are references to the quality of design, methods to monitor quality of design, and a direct reference to the use of traceable measurements for tests (see 3.2 (e)). Also, under ISO 13485, you need to control outsourced processes, and verify the quality of subcontractors.

So, you will need evidence the lab is competent and has traceability to meet these requirements. Accreditation is one way but not the only way.

Which is a rather interesting subject for IEC 60601-2-2, e.g. measurements of high voltage, current and power at 400kHz. I would expect most test labs won't have traceability if you ask them directly. National standards labs usually only provide traceability to 1kHz for any measurement involving a divider or transformer (e.g. high voltage, high current). Good luck!

Click to expand...

Hello Peter,

Thanks for the information which will be quite helpful for me. One more question. Is there any requirements relating to pattern of test report form for example clause by clause checklist type as is in case of CB Test Report?

Muhammad

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

Hello Steve,

Did you resolve the problem regarding orgination of test report form? I hope you would have. Anyway, I had a chance to review very briefly the published TRF. I doubted very much that the said TRF is applicable only to NCB and/or CBTL and not to the manufacturer's in house lab. So I think you can make your own form for test report. Please review Clause 2.1 of the published TRF which says

The request for a TRF is basically made by an IECEE member, which has presumably received an application for testing and certification of product(s) falling under a determined standard.............

As you know application for testing and certification are received by NCB and/or CBTL and not by the manufacturer. Also heading of the TRF is 'Worldwide System for Conformity Testing and Certification of Electrical Equipment and Components (IECEE)' What are your thoughts?

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

There is nothing which specifies the format of a report and in practice there is a wide variety used to support compliance with the MDD.

The 4 column format used in the CB scheme is convenient, especially when dealing with a standard that has many requirements.

The CB scheme protocols often contain many errors, especially for particular standards. The people in UL that write them often don't have much experience with particular standards (which is to be expected).

I've heard of cases where auditors have issued non-conformities to a manufacturer due to errors in CB scheme protocols (e.g. missing or wrong requirements). Note also the the CB scheme forms are intended to be supplemented by "test datasheets" that record things like date of test, equipment used, test set up, sample identification etc.

Preparing your own report form is a good idea, one that uses the 4-column format, but incorporates everything including the aspects normally recorded on a "test datasheet".

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

Thank you very much Peter. It's really very helpful information for me. I am new on this Forum and very much impressed by the useful information contributed by professional like you. Thanks once again.

Muhammad

Re: EN (IEC) 60601-1 – Is in-house testing definitely OK?

Hello Peter,

This is Muhammad again. I hope all is well with you. I was wondering if you could help me. My question is that can a manufacturer of HF Surgical Accessories (bipolar forceps, mono polar forceps, surgical pencil, cords) tests these in-house using an Electr-osurgical Unit (ESU) as current/ voltage source. For tests examples:

1) Active Accessory HF Leakage as required by 201.8.8.102 of ANSI/AAMI/IEC 60601-2-2:2009

2) Active Accessory HF dielectric Strength Test as required by 201.8.8.3.103 of ANSI/AAMI/IEC 60601-2-2:2009

3) Protection against the effects of short-circuiting of the electrodes as required by 201.13.2.13.101

Thanks