IEC 62133 to satisfy 60601-1 3rd edition - What happen to 60086-4

[rnepal]

We are medical device commpany and our device has Li-ion battery one user replaceable and one embedded in in side the device non user replaceable. We are in the process of getting certified for 60601 3rd edition. Our test house is asking us for 62133 certificate for battery but I did not see this requirement on 60601-1 3rd edition. Only requirement on 60601-1 3r edition is in section 15.4.3.4 for 60086-4. Can you please answer these:

- Do we have to comply with 61233 to meet 60601-1 3rd edition? ( what happen to 60086-4?)
- If yes, than do we have to test just battery for 61233 or, we have to test cell as well
- Do we have to test for any other UL std or, we are fine if we tested for 62133?

Your feedback will be very valuable for me.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.

 

[Pads38]

The requirement in edition 3 clause 15.4.3.4 is that lithium batteries (that could cause a hazard) should comply with IEC 60086-4. However if you check what that standard is you will see that it only covers lithium primary batteries.

Note.
Primary battery - non-rechargeable
Secondary battery - rechargeable

Edition 3 had a long gestation period - it took a long time to write, so rechargeable lithium batteries were not considered. This is being sorted out with the forthcoming amendment which introduces a requirement for secondary lithium batteries. That is that they comply with IEC 62133. (Primary lithiums still use 60086-4).

You could say that the test house is being unreasonable in demanding a requirement that has not even been officially published (it is still in draft; expected publication July/August this year). On the other hand they are helping to provide test results with a useful life of more than a few months.

I have been looking around for IEC 62133 batteries and there seem to be few, if any, available. Many manufacturers state compliance with UL 1642; I have seen test houses offering to do 'gap tests' on these to show 62133 compliance but I would expect that good battery manufacturers will have to get certified to 62133 anyway. If you have a chosen supplier I would ask them when they will be getting certified.

Note the phrase "...could become a hazard..." If your fixed battery is just a small coin cell for memory backup you may be able to show that even in the event of an internal short the amount of heat produced would be so low that no hazard (high external temperatures, fire etc) is created - so there is no requirement for compliance with any standard.

 

[SteveK]

In the other post on the subject, if you meet EN 60601-1 (3rd ed.) and have a CE marked/approved MD with rechargeable batteries (i.e. Li-ion, NiMH etc) there is no requirement indicated to meet IEC 62133.

http://elsmar.com/Forums/showthread.php?t=48602&highlight=iec+62133+60601-1

And to quote from a particular NB site (a number of others indicate the same) –

“The IECEE-CMC (Certification Management Committee) accepted a firm and final enforcement date of May 1, 2012 for battery standard IEC 62133, phasing out UL 1642. Products certified to IEC 60601 – including the 3rd Edition – are affected by this regulatory change. Manufacturers looking to bring products to global markets within the IECEE CB Scheme must abide by the same deadline.”

So my reading of this is that if you are not using the IECEE CB scheme i.e. following the MDD 93/42/EEC route for CE marked MDs certified via a NB (and showing compliance with EN 60601-1 3rd. Ed. and other relevant harmonized standards – noting that IEC 62133 is not harmonized), then this is not a requirement.

The NBs (with their associated test houses) certainly appear to be inferring that if your medical device does have rechargeable batteries then it MUST be tested/compliant with IEC 62133 i.e. usual money making scheme.

Am I right, any thoughts?

Steve

 

[Pads38]

I believe that you are right Steve.

The information that I got on the requirements for 62133 came from one of the CB test houses. Not for the first time their "information" has a certain amount of commercial spin placed upon it.

I got some more information just in the last couple of days that confirmed that the imminent requirement was as a result of agreement reached by the Certification Management Committee.

The 62133 requirement is still part of the forthcoming amendment to 60601-1 but, presumably, that will have a transition period after it's publication in the OJ, although that could be 18 months rather than 3 years as it is "just" an amendment.

 

[SteveK]

The 62133 requirement is still part of the forthcoming amendment to 60601-1 but, presumably, that will have a transition period after it's publication in the OJ, although that could be 18 months rather than 3 years as it is "just" an amendment.

Thanks for the back up!

From a working draft copy of EN 60601-1 Ed.3.1 (that I forgot I had!), the IEC 62133 requirement appears to be for secondary lithium batteries only. I guess this is due to their higher risk over say NiMH types - causing fires in certain instances etc.

Noting that it will still be a while before amendment implementation as you indicate, it is not stopping the test houses from trying to cash in now (and not just for Lithium type batteries).

Steve

 

[DaveK1956]

I'm new to the MD industry, but have to ask a question about IEC 62133 not being harmonized. What about EN 62133:2003. I believe it is published in OJEC, but I'll be darned if I can figure out how to verify that for sure.

My understanding is that if it is harmonized then it applies to the MDD.

Comments? Thanks.

 

[SteveK]

I'm new to the MD industry, but have to ask a question about IEC 62133 not being harmonized. What about EN 62133:2003. I believe it is published in OJEC, but I'll be darned if I can figure out how to verify that for sure.

My understanding is that if it is harmonized then it applies to the MDD.

Comments? Thanks.

It does not appear to be a harmonised standard as of 26.3.12

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/

Steve

 

[Pads38]

I doubt that 62133 will be listed in the OJ list of standards for the medical device directive as, after all, the battery is just a component in the device.

Instead it will be listed as a "Normative" reference in 60601-1 Ed 3.1, in the same way that IEC 61058 (Switches for appliances) is.

 

[DaveK1956]

Great reference link. Thanks.