UL Compliance

[[email protected]]

I am sorry . I meant OSHA does not recognize 3rd edition yet. jess

 

[Martin Riddle]

I am sorry . I meant OSHA does not recognize 3rd edition yet. jess

What does the FDA require?

Cheers

 

[Cydrome Leader]

Hi ,

I need some advise regarding compliance testing done by UL. We are intending to design a biomedical device ( an EKG machine) . And we want UL to do compliance testing aganist the following standards

1. UL 60601-1 (2006)
2. IEC / EN 60601-1 (1998+A1+A2)
3. ANSI / AAMI ES60601-1 ( 2005+C1+A2)
4. IEC EN 60601-1 (2005/2006 + C1+ C2) ( Europe, CE)
5. 60601-2-26(2002)


I have no information about the testing methods or what kind of test UL will perform on this device. I do not know about reasons that they can use to reject the device.

EKG machine:
1. Operated by UL approved 3.7V, 1A, LiIon battery. Battery can be charged by a UL approved charger. But when the battery is charging, EKG machine will be completely shut down by software. I am using the following "power connector"

http://www.digikey.com/product-search/en?lang=en&site=us&KeyWords=cp-065b-nd

Is this connector a good choice?

2. I am using the following box

http://www.okwenclosures.com/products/okw/ergo.htm

the "wrist" enclosure is hillarious. please use that one.

 

[[email protected]]

FDA requires 2nd edition. jess

 

[Martin Riddle]

FDA requires 2nd edition. jess

No, FDA requires 3rd Edition.

<http://www.ul.com/global/eng/pages/offerings/industries/healthsciences/606013rded/>

<http://www.accessdata.fda.gov/scrip...&utm_campaign=FDA+Transition&utm_medium=email>

Cheers

 

[[email protected]]

Thanks for sharing that UL info with me. I found the following link

http://www.ebme.co.uk/arts/safety/part3.php

The paper discusses leakage current. In my system design

1. The Enclouser will not be tied to earth because its plastic.
2. The Electronics section will be disconnected from the battery or be off when the user plugs the Battery Charger to charge the battery.

So, in my view
1. Earth leakage current
2. Enclosure leakage current or touch current
do not exsist for my device


But the following leakage current test

1. Patient leakage current
2. Patient auxiliary current
might exsist.

The problem is that you can see that even in these tests examples the enclouser is grounded and the transformer is plugged into the wall.

My device when plugged into the wall, does not work at all except charges battery. And my enclouser is not grounded at all.

So, How UL will test my unit. Will they short all the outputs of the AD1298 and then short it Lithium Ion battery + ve terminal or to its ground or short it to the AC voltage as shown in fig. 4b

Jess

 

[Martin Riddle]

Thanks for sharing that UL info with me. I found the following link

http://www.ebme.co.uk/arts/safety/part3.php

The paper discusses leakage current. In my system design

1. The Enclouser will not be tied to earth because its plastic.
2. The Electronics section will be disconnected from the battery or be off when the user plugs the Battery Charger to charge the battery.

So, in my view
1. Earth leakage current
2. Enclosure leakage current or touch current
do not exsist for my device


But the following leakage current test

1. Patient leakage current
2. Patient auxiliary current
might exsist.

The problem is that you can see that even in these tests examples the enclouser is grounded and the transformer is plugged into the wall.

My device when plugged into the wall, does not work at all except charges battery. And my enclouser is not grounded at all.

So, How UL will test my unit. Will they short all the outputs of the AD1298 and then short it Lithium Ion battery + ve terminal or to its ground or short it to the AC voltage as shown in fig. 4b

Jess

Look at it this way, Misuse. Operator tries to use the device while
charging. and connects the leads to the patient. (This is what Risk
Management is all about)

You should get a 60601 rated AC adaptor at minimum.

Seriously go to UL university and take the designing for 60601 course.

Cheers

 

[[email protected]]

Hi,

But the Charger's data sheet says on page 2 that it is approved for

IEC 60601-1, EN 60601-1, UL 60601-1


Data Sheet link: http://www.cui.com/product/resource/2247.pdf



jess

 

[Chris Jones]

Hi ,

I need some advise regarding compliance testing done by UL. We are intending to design a biomedical device ( an EKG machine) . And we want UL to do compliance testing aganist the following standards

1. UL 60601-1 (2006)
2. IEC / EN 60601-1 (1998+A1+A2)
3. ANSI / AAMI ES60601-1 ( 2005+C1+A2)
4. IEC EN 60601-1 (2005/2006 + C1+ C2) ( Europe, CE)
5. 60601-2-26(2002)


I have no information about the testing methods or what kind of test UL will perform on this device. I do not know about reasons that they can use to reject the device.

EKG machine:
1. Operated by UL approved 3.7V, 1A, LiIon battery. Battery can be charged by a UL approved charger. But when the battery is charging, EKG machine will be completely shut down by software. I am using the following "power connector"

http://www.digikey.com/product-search/en?lang=en&site=us&KeyWords=cp-065b-nd

Is this connector a good choice?

2. I am using the following box

http://www.okwenclosures.com/products/okw/ergo.htm

I do not know what should be the ingress ratings of the box and flammability ratings. Any advise!

3.

I have gathered following knowledge so far about the tests

1. Single Fault Condition : I am not able to find any clear answer for that. Can anyone give a simple to undertsaned explanation?
2. Ingress rating test: do not know how will they test
3. EMC test
4. Enclosuer mechanical robustness test.

What other tests should I keep in mind before we start designing this machine.

Jess

If you try to enforce not charging the device whilst in use by just
software, the user will only find that out after they are already
connected to the wall wart, and experiencing whatever consequences you
were trying to avoid.

Why not make the battery removable, and omit any charging socket on the
device itself. You can provide a separate charging station that the
battery fits into, and which connects to the wall-wart. Some parts of
this arrangement might already be available off-the-shelf.

Failing that, if permitted by the standard you could place the electrode
connector and charging socket such that it is mechanically impossible to
connect anything to one connector whilst the other connector is in use.
(e.g. a sturdy sliding door that exposes only one connector at a time.)

Both ways you can make it impractical for a user to attempt to charge
the battery whilst connected to the electrodes. I'm not sure if the
standards have anything to say about that as I don't have a copy.

Chris

 

[[email protected]]

Why not make the battery removable, and omit any charging socket on the device >itself. You can provide a separate charging station that the battery fits >into, and which connects to the wall-wart. Some parts of this arrangement >might already be available off-the-shelf.

The things is that the user can go and get a non UL approved LiIon Battery and use it if I go with the removable battery option.

Failing that, if permitted by the standard you could place the electrode >connector and charging socket such that it is mechanically impossible to >connect anything to one connector whilst the other connector is in use. (e.g.. >a sturdy sliding door that exposes only one connector at a time.) Both ways >you can make it impractical for a user to attempt to charge the battery whilst >connected to the electrodes. I'm not sure if the standards have anything to >say about that as I don't have a copy. Chris

Sliding doors can effect the ingress rating of the enclouser.


jess