Usability Engineering ISO 62366:2008 - Medical Devices

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Ronen E

Problem Solver
Staff member
Moderator
#52
My question is, why does each country, region, etc. use their own prefix?
And most importantly, is there a difference between them???
I have a copy of BS EN 62366. If I comply with this, can I also state that I comply with the ISO version, the IEC version, etc.
Hi,

1. I'll leave the "why" question to those more deeply involved with those systems (I think there are a few around here). For implementation purposes it doesn't really matter. All that matters is which ones you have to comply with for achieving a given goal.

2. Yes, there may be differences. Sometimes significant, other times just editorial. For instance, when an IEC or ISO standard is endorsed by Cenelec or CEN to become an EN standard, it may be somewhat modified. On the other hand, as far as I understand, an EN standard that is adopted on EC national level (e.g. BS, DIN etc.) has to be identical in contents to the parent EN version. The reason is that compliance with the MDD (which may be served by compliance with harmonized standards) is legally achieved on EC national level. The MDD (and any amendment of it) is transposed into EC national legislation, and this is what companies actually comply with, even though on a practical level we ususally refer directly to the EC MDD. EC national legislation requires the existence of the harmonised standards on a national level, so it can refer it like the MDD refers to EN standards, and hence the national adopted versions of those standards. Since this is an overarching EC system, it has to work identically in all member states, and that's why all the national adopted versions have to be identical to the EN parent.

3. If you comply with BS EN "whatever", you can claim you comply with the same EN, but not necessarily with the same ISO or IEC.

Cheers,
Ronen.
 
D

DangerousDave

#54
Thanks to everyone (especially the ones that contributed the attachments and experience!) for this thread! Very informative...

I am yet another who has to conform to 62366 with existing products designed 10 yrs ago...

My question has to do with the different Prefixes attached to this (or any other) Std....
Theres ISO, IEC, BS EN, etc., etc. I know what they stand for (eg. ISO = International Standards Org., ect.), so thats not my question...
My question is, why does each country, region, etc. use their own prefix?
And most importantly, is there a difference between them???
I have a copy of BS EN 62366. If I comply with this, can I also state that I comply with the ISO version, the IEC version, etc.
OK, think I beat that horse to death...want to make sure you 'get' it!!
Thanks in advance!
Pete
In addition to the previous post, usually if prefixes remain it means the standard is identical to other prefixes, so for example, BS EN ISO 14971, means the BS (British) standard is identical to the EN (European) standard and is identical to the ISO standard. If prefixes are removed i.e. BS EN 62366, it means the BS standard is identical to the EN standard, but is not to the international version, IEC in this case I think.

This is not always true as it can mean the standard was simply adopted in a different year. One example is that BS EN 60601-1 is identical to IEC 60601-1 but BS EN 60601-1 was released in 2006 and the IEC version in 2005.
 
#55
And regarding older (legacy) devices...IEC 62366 is being revised at the moment and will problably have an alternative compliance process that can be used with legacy devices.
Can you give us any idea of time scales for this?

The SC62A committee page on the IEC web site would seem to suggest that any new publications won't be for some years.
 

Marcelo

Inactive Registered Visitor
#56
Can you give us any idea of time scales for this?

The SC62A committee page on the IEC web site would seem to suggest that any new publications won't be for some years.
JWG 4 (JWG 3 in ISO) is somewhat late in the revision of 62366. However, it was decided in the last meeting (Nuremberg, october 2011) that things must speed up. JWG 3 will have three meeting in 2012 (plus one non-official meeting to create the initial draft revision document - there will be two documents in fact, IEC 62366-1 and IEC 62366-2).

It's expected that this way a formal draft an be circulated to national comittees this year. However, until final publication there will problably be noe more year at least (please remember the the usual timeframe to create/review a standards is 36 months). SO we will problably hae the standard in the beginning of 2014 if everything is ok.
 
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