IEC 60601 - List of required tests - Medical Device Class IB

M

Martin IT

#1
Hello everyone,

I work for a company that produce MD class IB. Every
product is tested for the electric security.
This is a list of tests performed:

• Earth Continuity Test
• Insulation Test
• Powered Test
• Load Test
• Earth Leakage, normal condition Test
• Earth Leakage, single fault, supply Test
• Enclosure leakage, normal condition Test
• Enclosure leakage, single fault, supply open
Test
• Enclosure leakage, single fault, earth open
Test

Is this list test complete to be compliant with the 3rd
edition of 60601? We have to introduce the something
else?
 
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Marcelo

Inactive Registered Visitor
#2
Re: 60601 whath kind of test?

I´m not sure what you mean. You mean routine tests in all samples of the finished products?

Or you mean type tests to determine safety of the product and copliance with regulatory requirements?
 
M

Martin IT

#3
Re: 60601 whath kind of test?

sorry you're right, I was not clear enough in explain!

I mean routine test for our finished product ( the product is already CE marked and the prototype was tested to be compliant with the IEC EN 60601 in a specilized laboratory, but for every finished product we have to make same tests ).

My first doubt is: must I implement the Dielectric strength Test?

I´m not sure what you mean. You mean routine tests in all samples of the finished products?

Or you mean type tests to determine safety of the product and copliance with regulatory requirements?
 

Marcelo

Inactive Registered Visitor
#4
Re: IEC 60601 - List of required tests? MD class IB

Dielectric strength Test
For CE Marking, it´s generally expected that you perform dielectric routine tests, but it really depends on the position of your notified body, so you should ask them this question.

The problem with dielectric strenght is that it´s a very destructive test. In Brazil, we are changing the routine tests required. We´ll begin using IEC 62353, which uses insulation resistance testing in place of the hipot test. Insulation resistance also measure the quality of the insulatio nbarriers, but does not damage the equipment.

You might use a rationale of this kind for justifying not implementing routine dielectric strenght testing, and then ask what your notified body thinks about it.
 
M

Martin IT

#5
Re: IEC 60601 - List of required tests? MD class IB

Thanks.

I agree with you, the great problem is that this kind of test is too much strength.

My doubt is if this test is mandatory or not! Do you think I can use something else ( like the insulation Test ).

I appreciate your suggest, I'll call the NB!

The last question, in the 3rd version of IEC EN 60601 there are something explicit on what kind of tests are mandatory?
 

Marcelo

Inactive Registered Visitor
#6
Re: IEC 60601 - List of required tests? MD class IB

There´s nothign on routine testing for the finished product on the third edition, although there are requirements for routine testing of some components.
 
A

Andromeda123

#8
Re: IEC 60601 - List of required tests? MD class IB

For CE Marking, it?s generally expected that you perform dielectric routine tests, but it really depends on the position of your notified body, so you should ask them this question.

The problem with dielectric strenght is that it?s a very destructive test. In Brazil, we are changing the routine tests required. We?ll begin using IEC 62353, which uses insulation resistance testing in place of the hipot test. Insulation resistance also measure the quality of the insulatio nbarriers, but does not damage the equipment.

You might use a rationale of this kind for justifying not implementing routine dielectric strenght testing, and then ask what your notified body thinks about it.
Hello Marcelo,

I know, this topic is already a bit old, but nevertheless a high priority subject in our company: Is there already an update regarding IEC 62353 available? I think currently we still need to comply with 60601 and so th hipot tests are still compulsary? Rigth?
Is it known, how long the tests need to take place? 60 Seconds for the type testing , but can be reduced for the routine tests... Is 5 Seconds ok in general or are there some guidelines availabe?

I would appreciate your answer very much.

Regards
 
#9
Re: IEC 60601 - List of required tests? MD class IB

(IEC) 60601-1 is a Type Test standard and can be destructive, as Marcello has highlighted.

(IEC) 62353 is described as "recurrent test and test after repair". The tests it describes could be used as 'Production Tests'.

The dielectric strength test (hi-pot test) should only be done to test solid insulations. It can invisibly damage insulation.

If you do a dielectric test on a finished device you will likely stress several insulations together, with the stress voltage being 'shared' unevenly between them. It is a much more valid test when only testing one insulation at a time, such as on a single component.

We do a dielectric type test on the transformers we use. This is held for 1 minute (as required by 60601-1). After this test the component is quarantined and considered to be damaged and unusable. For production tests we do the same test, with the same test voltage, but only for 5 seconds.
 
A

Andromeda123

#10
Re: IEC 60601 - List of required tests? MD class IB

(IEC) 60601-1 is a Type Test standard and can be destructive, as Marcello has highlighted.

(IEC) 62353 is described as "recurrent test and test after repair". The tests it describes could be used as 'Production Tests'.

The dielectric strength test (hi-pot test) should only be done to test solid insulations. It can invisibly damage insulation.

If you do a dielectric test on a finished device you will likely stress several insulations together, with the stress voltage being 'shared' unevenly between them. It is a much more valid test when only testing one insulation at a time, such as on a single component.

We do a dielectric type test on the transformers we use. This is held for 1 minute (as required by 60601-1). After this test the component is quarantined and considered to be damaged and unusable. For production tests we do the same test, with the same test voltage, but only for 5 seconds.
Hi Pads38,

Thank you for your quick answer.
I was considering the requirements for Brasil (Sorry i was not specific and am not sure if you are..).
For the registration in Brasil, we need to show proove of the routine tests we do, and so far we did not performe hi pot routine tests... So I'm wondering about this "New" requirements in 62353. So far I'm aware of the "orinance 350, Appendix A" wherer the 60601-1 routine tests are requested.

Thnx for any feedback.

Regards
 
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