Harmonization date of IEC 60601-1 , 3rd Edition

The law states that the alternate solution shall be identified if a harmonized standard is not applied. So, if EN 60601-1:2006 is the harmonized standard, and the alternate solution is not identified, it is a valid non-conformity.

If EN 60601-1:2006 is the harmonized standard, and EN 60601-1:1990/A2:1995 is identified as the alternate solution, it is OK as long as the new items in EN 60601-1:2005 are identified and explained as being not important.

Unfortunately this means you still need to know the detail in latest standard and need some kind of record that it has been reviewed and is not significant for your particular device.

For example, in the old standard, one of the tests for patient support used only patient's weight, not the full weight of the system being supported (e.g. the top part of the table). It was wrong, and this mistake has now has been corrected in the 2006 edition. If that test is applicable to your device, it's hard to argue that EN 60601-1:1990 is an appropriate "alternate solution".

So can't avoid a clause by clause check. The alternate solutions need to be offered for each individual clause. You cannot ignore the whole standard and say the alternate solution is the older standard.

Peter Selvey said:

The request from the NB strongly suggests an auditor not really familiar with how the 601 series works and is just running on a high level checklist. It can get complicated and the auditors have to cover a lot of ground, so just gently ask them to double check.

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Peter, NB gave the reason as follows:
Since 2rd is not harmonized, only complying with 2rd is not enough.
Since 3rd is harmonized, that means there are additional requirement to be considered. Only complying with these additional requirement can meet ER.

The NB is from Germany, I think all can know it. Can I use your point that particular standard overid general one to argue with him?

I would recommend to ask the auditor to write it up as a formal non-compliance.

Firstly, that will clarify exactly what the NB is saying (not, for example a misinterpretation), and also provide an formal opportunity to challenge. Regulations controlling the NBs require a formal complaints procedure which allows a non-conformity to be challenged (and of course, everyone makes mistakes, so it's not a big deal to use this procedure).

While I can understand a single auditor might have a misunderstanding of the regulation, the core certification body will surely have a better understanding and will be very careful to make the correct response.

Hello,

Can anyone tell me if the 3rd edition of IEC 60601 standard is required for an electrical investigational medical device to be use in a clinical trial only (not for CE Mark)?

Thank you,
Noa

Have a look at MDD, Article 15 and in particular Annex VIII.

You will find that this annex contains the same provisions with respect to standards as do the other annexes for CE marking, i.e. you can use the harmonized standards, or if not, you have to show how your device meets the essential requirements.

So basically it is the same deal as a CE marked device.

In practice, it might be that if the number of devices is small, or even just one device, and the device has special installation, monitoring and training for use, you could argue many of the provisions in EN 60601-1 are not so important. But really you would have to check the content of the standard first and then decide which is appropriate or not. So, you end up still "testing" to the standard, but not necessarily complying. Having a 601 experienced engineer on hand to make quick common sense judgments would be great, as there are ~1500 discrete requirements in the standard.

You could imagine an extreme situation where no requirements at all are applied, and the device ends up burning down a hospital, shocking or burns the patient. Obviously the regulations cannot allow this, even for a clinical trial.

No. 3rd edition is not required, nor is it acceptable in certain countries. So you need to be a little more specific about which country your talking about. Any hospital in the United States that uses a 3rd edition certified product will be in violation of 29 CFR Part 1910.303 and subject to a fine by OSHA. OSHA does not believe 60601-1 3rd edition certified products can provide enough confidence for meeting the basic safety requriements of the regulation.

FDA should begin to recognize AAMI IEC 60601-1 3rd edition, but you are not required to use it unless you have elected to use that standard by your own choice for meeting whatever safety and performance requirements you choose to use it for. Standards are voluntary in the U.S., with the exception of OSHA, where you cannot get an NRTL mark without using one.

FDA does not require that you use any standard, and they do not require that you apply the whole standard, even when the standard itself demands that certification to it cannot be achieved without fully applying all parts (as 3rd edition certification implies).

Standards are also entirely voluntary in Europe, although certain Notified Bodies are promising to revoke their CE certs if you do not apply IEC 60601-1 3rd edition. Standards are voluntary in Europe as well.