Harmonization date of IEC 60601-1 , 3rd Edition

[Marcelo]

Mark

I know there are some inconsistencies between IEC committees, but what i was trying to say is that IEC is not responsible for transitional periods. Transitional periods are given by regulatory bodies, not standards developing bodies - the standard developing bodies such as IEC only develop the standard document..wheter or not the developed standard is used in a regulation is defined by the regulatory body of each country or region, not by IEC.

Anyway, you´re right in this last case you mentioned.

In general, it can be expected that 2012 is a good estimate of beginning of general use of IEC 60601-1 third edition, because the more important regulatory systems, such as USA, EU and Canada, have used this date (FDA is still developing it´s policy but will likely use this date also). And other countries will need to maintain a similar date not to have problems. For example, this will be the case in Brazil.


The only problem of this general discussion is that we´ve already discussed this before, and in this theread, the main concern is the exact date, specifically regarding the harmonization in EU. That´s why i´m trying to keep the discussions on a exact and official data-backed way. Sorry if i seem a little pushy sometimes, but a lot of people come here looking for this answer (just google "iec 60601 third edition eu" and you wil see this page is the first result).

 

[mark walker]

Hi Marcelo,

On a different subject one of my collegues is on the NB-MED commitee and they have been told to re-write the GHTF STED requirements due to lack of EU content

 

[Stijloor]

Hi Marcelo,

On a different subject one of my collegues is on the NB-MED commitee and they have been told to re-write the GHTF STED requirements due to lack of EU content

Mark,

What do these acronyms mean?

• NB-MED
• GHTF STED
• EU = European Union?

Stijloor.

 

[Marcelo]

Hi Mark

You´re right. In fact, as far as i know, the GHTF will revise the essential principles, due to the revision of the EU Directives which introduced new essential principles do the medical device directives...the essential principles from the GTHF we have now were based on the EU, so it´s really a matter of continuation to update them right now.

As the essential principles are base to otherGHTF docs, including the STED, these other documents will also have to be updated.

 

[Marcelo]

NB-MED
GHTF STED
EU = European Union?

NB-MED = notified bodies medical devices....it´s an "association" of notified bodies for the medical devices directives which, among other things, publishes guidance documents on the application of the directives. Their website cab be seen here: http://www.team-nb.org/, and their documents, which are called NM-MED xxx, can be seen on the sidebar link.

GHTF = global harmonization task force, an international group which aims to harmonise medical devices regulations around the world. They have a lot of interesting guidance documents, and their website can be reache in this link: http://www.ghtf.org/

STED means summary technical documentation...in the case of GHTF, there´s a guidance document named "Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)" - you can see it in the archive of GHTF study group 1 documents: http://www.ghtf.org/sg1/sg1-archived.html

And yes, EU is European Union

 

[Stijloor]

Marcelo,

Thank you very much for the information!

It will also help other Covers who are not as familiar with the international Medical Devices industry and who are interested in learning about it.

Stijloor.

 

[Marcelo]

A new list of harmonized standards has been published, but still no sign of the expiration date of the old edition of EN 60601-1:

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:2009:293:SOM:EN:HTML

 

[recruit]

A new list of harmonized standards has been published, but still no sign of the expiration date of the old edition of EN 60601-1:

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:2009:293:SOM:EN:HTML

Thanks, Marcelo.
Did you find that EN ISO 9919:2009 would replace EN ISO 9919:2005 in 2010? But BSI website indicates both EN standards are identical with ISO 9919:2005.
What's different between the EN 2009 and 2005 version?

BSI links:
http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030193630
http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030022575

 

[Marcelo]

I´m not 100 % sure, but i´ve seen a lot of EN standards updated in 2009 not due to a change in the original ISO standards (which was not revised, anyway), but to ad some annexes regarding the use of the standard in conkunction with the medical devices directives.

This was the case of EN ISO 14971:2009, and i think it´s the same case here.

 

[recruit]

I´m not 100 % sure, but i´ve seen a lot of EN standards updated in 2009 not due to a change in the original ISO standards (which was not revised, anyway), but to ad some annexes regarding the use of the standard in conkunction with the medical devices directives.

This was the case of EN ISO 14971:2009, and i think it´s the same case here.

Thanks. I checked with BSI. Only both annexes was added. No essential update.