Immuity testing medical equipment

Has anyone actually prepared a test plan for CE compliance for medical equipment, specifically with regards to RF immunity?

I have not had to do this before for this type of equipment

Specific standards, limits and clauses etc.

Any help would be good

:R

Hi,

I've made a 'electrocardiogram' before. It was easy, I just made the thing using opamps (to amplify small signals of the P an Q waves of the heart pulse) then sent it off the the people who checks the safety of theses things (always include optocoupler for safety). They said it was ok pretty quickly. So, its not so hard.

So how did you compile the testing & validation plan?

How did the testing house know what pass/fail is?

I cannot see how you can validate a design without considering immunity especially for such equipment.

Under ISO this is a requirement before the design leaves concept.

:R

Hi

I guess it is not different to ohter EMC testing........ though I do not work on medical devices. To see the relevant applicable standard you have to check the EU Official Journal relevant to the EMC directive which refers to the applicable standard, version and date.
I guess for such products you need to follow IEC61000-4-6 for radiated immunity testing.
I guess for such equipment you need to maintain performance criterium "A", no failure when applying the interference field.

Please note radiated testing acc. the -6 is only a small part of the total testsuite. You need to do conducted voltage,current,power, ESD, EFT, etc etc etc

rgds

Take a look at IEC60601-1-2. It describes test levels and requirements. You will also need to check particular standard for your equipment, sometimes it differs from type to type. So, at first, you need to choose "basic" standard for your device. There should be Section 36, check it for particular test reqirements.
For test methods look at IEC61000-4-2(Electrostatic discharge immunity test), IEC61000-4-3(Radiated, radio-frequency, electromagnetic field immunity test), IEC61000-4-5(Surge immunity test), IEC61000-4-6(Testing and measurement techniques Voltage dips, short interruptions and voltage variations immunity tests). May be this list is incomplete, but i can't remebmer all others.
But, in general, any EMC lab has own testplan, you only need to supply them with your divece and to look after them, to prevent damage for the device... ;-)

alex

Oh, I'm sorry... I've skipped statement about ISO...
For this crap you only need to state, that you will make a test according to IEC60601-1-2 at predefined time. (You will never fulfill this...) Take some future day. But you still need to look for test levels and requirements.
alex

alex840 said:

Oh, I'm sorry... I've skipped statement about ISO...
For this crap you only need to state, that you will make a test according to IEC60601-1-2 at predefined time. (You will never fulfill this...) Take some future day. But you still need to look for test levels and requirements.
alex

Click to expand...

1st ISO is not crap :lol: it is a neccessary evil.

2nd ANY serious project requires planning, however there is a lot more to a CE/standards compliance testing/validation plan than just a single part of the standards required.

CE compliance starts at product specification, well before any design stage, this is the way it must be done, unless you have money to burn later.

What I was after was a tree of the additional standards or compliance data required that were specific to medical equipment so I can be better informed before I meet with the consultants to finalise the product specifications / requirements.

:R

j2356r said:

1st ISO is not crap :lol: it is a neccessary evil.

2nd ANY serious project requires planning, however there is a lot more to a CE/standards compliance testing/validation plan than just a single part of the standards required.

CE compliance starts at product specification, well before any design stage, this is the way it must be done, unless you have money to burn later.

What I was after was a tree of the additional standards or compliance data required that were specific to medical equipment so I can be better informed before I meet with the consultants to finalise the product specifications / requirements.

:R

Click to expand...

yeah, i know this. you need to write spec and vefification/validation plan prior to design itself... I've done several CE projects, including v/v plans.
May be I don't understand what you are asking for?
All testcases are clearly specified by IEC60601-1-2, clauses 36.202.x. You need only to check clause 36 of particular standard for you device (IEC60601-2-x, I don't know what device you plan to design), because particular standard supersedes general one. After it you will get nearly complete v/v plan, with exact testlevels, pass/fail criteria and references to test methods. You don't need to write test methods to v/v plan, if you have no own EMC lab. You can just describe tests as it specified by 601-1-2.
P.S. do not forget to classify you device: life-supproting, non life supporting and so on..