Infusion Pump and IEC 60601 2nd edition

Dear friends

I 'd like to ask you about the iec 60601-1 3rd edition and infusion pumps.
Because of the iec 60601-2-24 new edition 2012
a) what is the latest date that we can use infusion pumps which is complied with 60601-1 2nd edition for europe market and
b) what is the latest date that we can sale infusion pump which is complied with 60601-1 2nd edition for europe market.

Thanks

A Quick Bump!

Can someone help?

Thank you very much!!

If there are no special issues, Europe normally applies a 3 year transition period from the date of publication as an IEC standards. However, some of these particulars are the subject to debate, discussion or technical issues, so several have not been harmonized yet.

For example IEC 80601-2-30 was published in 2009, but still not yet appearing the Official Journal, possibly because of conflicts with the EN 1060-xx series.

But at least, you can expect the earliest will be October 2015.

For sales, I remember something about clearing stocks in the distribution chain but I would need to read up again. It should be in a MEDDEV somewhere.

One of the issues that we've been seeing with Notified Body inspections is that they are considering long-published standards (such as 60601-1 3rd Edition and 60601-2-24 2nd Edition) as "state of the art" with regards to being evaluated for the essential requirements, whether or not they are harmonized. We haven't seen any non-conformities in audits yet, but it has been discussed that we should have gap analyses in our DHF showing that we've evaluated the new standards and that from a risk management perspective we are not less safe than the "state of the art".

I don't particularly object to this from a technical perspective for the regular infusion pump, but applying an essentially new nutrition pump standard (nutrition pumps were added to the scope of 60601-2-24 in 2nd Edition) as state-of-the-art, when much of industry thinks there are problems with the standard itself, is putting us into a regulatory dilemma. We're basically working in the technical groups and hoping that the standard gets changed before we have to implement it.

Has anyone else had Notified Bodies starting to expect state-of-the-art with respect to standards that aren't harmonized?

Kat

There are two levels here.

It is reasonable for the NB to expect new standards (and even old standards that not yet adopted) to be used as inputs to periodic post market activities as referred to in ISO 14971 (Clause 9) and referred to in the directive (Annex X and general post market obligations).

However these are just inputs to analysis, such standard have not reached the status of giving a "presumption of conformity", with formal legal implications if not applied.

A new standard is an important reference and there may be good stuff in there that is worth implementing ahead of any formal recognition. Also the standard might be held up getting harmonized for some particular controversial requirement, but there may be other requirements that are perfectly reasonable to apply without delay, or at least incorporate into the next design upgrade.

But if the NB is saying that a standards automatically represent "state of the art" as soon as they are published, they are stepping over the line.

The minimum requirement is to show that the standard has been reviewed and decision made whether any requirements should be adopted. The record should exist as part of the post market periodic review activity. If the record cannot be found, it is reasonable for a non-conformity to be raised.

The NB may reasonably question the decision in the record, but note they also need "objective evidence" to support a non-conformity. If the above record exists, the correct procedure has been followed, so the non-conformity relates to the engineering or risk based judgement. The evidence should consist of a feasible rationale, incident reports or other information showing that the particular requirement is worth implementing ahead of formal adoption. They cannot broadly or blindly say that all published standards are automatically state of the art.

Well said, peter.

We are facing the same problem also. The NB requires hemodialysis machine to be tested to IEC 60601-2-16:2012 although EN 60601-2-16:1998 is the harmonized standard in OJ.

I am afraid that the machine would fail the clause 201.12.4.4.105 of 60601-1:2012 since the air detector positioned on the blood tubing is designed to detect a bolus (single bubble > 20 ul). From the rationale, it seems that air detector should be capable of detecting continuous infusion of air and infusion of a bolus.

For -2-16, a limit of 20uL is a very small amount, air below this would probably be considered negligible (of course, check with clinical literature).

If your system always triggers at that level it should be OK to pass both tests.

In functional tests of safety systems it is normal have at least two tests: the slow test - gradually works up to triggering point the system, and the fast test: hit it as hard as possible (max power/flow/energy). Depending on the design, delays or complicated algorithms the outcome of the two tests can be very different. It looks like the two tests in the standard (gradual increase / bolus) are just the equivalent of the slow/fast test approach which should have been applied even in the 2nd edition tests.

The 2012 edition air detector test does have an interesting new aspect: "capacitive" flow due to a pressurized circuit (blood flow even if the blood pump stops). I think this is a good example of something worth to be investigated even though the standard is not harmonized.

If your system always triggers at that level it should be OK to pass both tests

Click to expand...

No. Alarm will not be generated when bubble is less than 20 ul. That said continuous micro bubbles (says, each is 19 ul) cannot be detected. If there are 20 bubbles, the accumulated volume will be 380 ul. The algorithm takes no account of accumulated volume of single bubbles.

I am not sure if the test procedure of continuous air infusion must be applied or can be optional. As I know, some hemodialysis machines monitor bolus and accumulated volume as well. Some monitor the level of venous drip chamber and foam, and some monitor the bolus.

Should the two test procedures (continuous air infusion and bolus air infusion) be applied in any case?

It looks like the two tests in the standard (gradual increase / bolus) are just the equivalent of the slow/fast test approach which should have been applied even in the 2nd edition tests.

Click to expand...

The 2nd edition does not have such detailed requirements. And the first generation machine actually has been certified by TUV SUD.