IEC 62366 vs. IEC 60601-1-6 - Has IEC 62366 now replaced IEC 60601-1-6?

Marcelo, et. al,

Intertek, our safety testing agency, has stated that compliance with 60601-1-6 is not mandatory until such time as 60601-1 3rd Ed is harmonized. This was news to me. I thought all the collateral standards to 60601 were in effect during the current tenure of 60601-1 2nd Ed. We manufacture a Class IIa active medical device. Can someone pls clarify this for me?

Conversely, our Notified Body has made reference to both 60601-1-6 & 62366. From their perspective, if we claim compliance with 60601-1 2nd Ed, the requirements in 60601-1-6 also apply to us. We have the option of complying instead with 62366, but it seems it's either one or the other.

Watchwait said:

Intertek, our safety testing agency, has stated that compliance with 60601-1-6 is not mandatory until such time as 60601-1 3rd Ed is harmonized.

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Presumably because of the "harmonized" qualifier, this comment was specifically in reference to EC applicability?

According to its Foreward, the 2006 edition of IEC 60601-1-6 was "revised to structurally align it with the 2005 edition of IEC 60601-1", i.e. Third Edition. It could be that the 2006 edition of 60601-1-6 would be linked to the Third Edition in regard to applicability, but in that case I don't see why the prior version of 60601-1-6 wouldn't instead be applicable.

My understanding per the Foreward is that the "principal technical" difference between the two versions is the recognition of a risk management requirement in the 2005 and 2006 versions respectively.

I know all medical devices have to meet the MDD and thus have to meet the ER, but does that necessarily mean they have to meet IEC 62366?

I know all medical devices have to meet the MDD and thus have to meet the ER, but does that necessarily mean they have to meet IEC 62366?

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The essential requirements give general provisions which must be met, including usability requirements.

The way the new approach directives are structured, standards are voluntary (they are possible technical solutions to address the general essentil requirements), but harmonized statandards are considered the state of the art i nthis matter. So, in practice, if you do not meet an harmonized standard, you have to justify that other solution you implemented has the same "level of safety" that your product would have achieved if you wer to use the harmonized standard. All this have to be showed by applying a proper risk management process.

I see. So meeting ISO 62366 in full is the easiest way to meet the ER requirement in the 2007 version of the MDD (Annex I, Section I, part 1) that states something about reducing risks of use error and taking into account the knowledge, education, physical conditions, etc... of the intended user? If I meet it in part or not at all, as you indicate, I can try and justify why it's ok that I don't meet it?

I see. So meeting ISO 62366 in full is the easiest way to meet the ER requirement in the 2007 version of the MDD (Annex I, Section I, part 1) that states something about reducing risks of use error and taking into account the knowledge, education, physical conditions, etc... of the intended user? If I meet it in part or not at all, as you indicate, I can try and justify why it's ok that I don't meet it?

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Yes, 62366 was harmonized to provide presumption of conformity to the folowwing new essential requirements:

– reducing, as far as possible, the risk of use error due to the ergonomic features of the device and
the environment in which the device is intended to be used (design for patient safety), and
– consideration of the technical knowledge, experience, education and training and where
applicable the medical and physical conditions of intended users (design for lay, professional,
disabled or other users).

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Also part of

13.1. Each device must be accompanied by the information needed to use it safely and properly, taking
account of the training and knowledge of the potential users, and to identify the manufacturer.

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Please not eaht usability requirements always existed in the MDD, the only thing now is that they are explicitly required and there´s as harmonized standard which guives presumption of conformity.

And yes, if you meet it in part or not at all, you can still be ok, provided that you can justify that the level of safety is the same (also, please note that this approach is what is theoretical requirerd, but i know this can be different for different notified bodies - for example, there´s a lot of NBs which still always requires conformity with standards..so, i would obviously advise discussing this matter with your NB).

Re: IEC 62366 vs. IEC 60601 - Has IEC 62366 now replaced IEC 60601?

MMANTUNES,

I know you've responded to posts in the past that Brazil requires conformance to the IEC standards (vs optional in EU). Do you know if Brazilian law includes IEC60601-1-6 or does Brazil only require conformance to the base IEC60601-1? Its going to be fun keeping up with both 1-6 AND EN62366 documentation...

I know you've responded to posts in the past that Brazil requires conformance to the IEC standards (vs optional in EU). Do you know if Brazilian law includes IEC60601-1-6 or does Brazil only require conformance to the base IEC60601-1? Its going to be fun keeping up with both 1-6 AND EN62366 documentation...

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Only IEC 60601-1, 1-1, 1-2, 1-3 and 1-4 (second edition). We do not have the old 1-6 and 1-8 so they are not mandatory. We will publish 1-6 (third edition) but it will only ne mandatory in some years (when third edition becomes mandatory in Brazil). We´ve already have a brazilian version of 62366 but it´s not mandatory.

Anyway, it would´nt be much of a problem to keeo documentation for 1-6 and 62366 as they are essentially (99.9 %) the same.

I went to the CENELEC web site and saw a Project: EN 62366:2008 with a date of withdrawal of 2010-12-01 and no replacement indcated. Then under Project: EN 60601-1-6 the 2010 edition was shown to be superceding 60601-1-6:2007 and the 2010 version showed a date of withdrawal of 2013-04-01.

Which edition of which standard is what I should be targeting for my organization if I want to ship Class II (a or b) devices into Europe after June 2012.

Can you tell me the step by step process followed by the manufacturer in order to comply its device with IEC 62366? Also, would like to know how is the testing done in order to check the compliance with IEC 62366?