Harmonization dates of IEC 60601-1-2:2014

nikolaos

Quite Involved in Discussions
#1
Hi,
From what I know the effective dates of compliance for US and EU is December 31, 2019. What about the other countries? Cina, Japan, Brazil...
Testing now a new MD is sufficient compliance to the fourth ed. 2014 or still third ed. 2007 is recommended?
Thank you
 

Pads38

Quite Involved in Discussions
#3
Hi Nikolas,

I attended a seminar on the Ed 4 EMC standard. One of the things that was discussed was that there is no unified dates for the introduction. Indeed, some countries will still only accept Edition 2 testing!

Some countries will also likely only accept tests performed at their mains supply / frequency combination - even for those tests where it would make no difference.
 

Shamann2

Involved In Discussions
#4
A related question...

I'm trying to confirm that in the US, if a device has a valid 510(k) with an older version of a standard, the company can continue manufacturing and selling that device without being required to retest to the new version. It's understood that a new submission requires testing to the current version.

For products that were manufactured before the required implementation date of the standard, can those specific products continue to be sold into Europe and other countries, or do all products sold after that date need to be compliant to the new version?
 

Peter Selvey

Trusted Information Resource
Trusted
#5
Europe and US are fundamentally different in the underlying law that applies.

For the US, the law is based on "clearance for sale": once the FDA provides this clearance, the manufacturer has the right to continue to sell the product "ad infinitum", as long as the design does not change. To be clear, it's a stupid law, but one of those things that made sense 50+ years ago and never got changed, because most people don't realise how stupid the law is. But the good point is that if an EMC standard changes ... no need to re-test.

The EU has a different approach: for most medical devices there is no clearance for sale for the individual product. The certification process is for the manufacturer, which then gives them the freedom to make design changes or design decisions without having to seek approval. It's up to the manufacturer to monitor the changes in the standards and decide what to do with them. Which is very much a case by case decision.
 

Chromehounds

Starting to get Involved
#6
Hi All,

When is it required of the Manufacturer to apply the 60601-1-2:2015 standard? Our product has been CE marked to the 2007 version and in the EU since 2012. :thanks:
 

Pads38

Quite Involved in Discussions
#7
Hi Chrome,

Assuming that you are primarily interested in the EU market -

Standards are made 'official' by being 'harmonised' and being listed in the EU Official Journal - the OJ. Search for 'MDD OJ' and you will find this:-

Medical devices - European Commission

Just down that page you will find links to different language pdf listings of the OJ, the latest being 17th Nov 2017.

From that you will find that the current 60601-1-2 is EN60601-1-2:2015 (identical to the 2014 IEC version). It was first published in the OJ on 13/5/2016.

The Date of Cessation of Presumption of Conformity of Superseded Standard (DOCOPOCOSS !) is 31/12/2018 - so officially the 2007 version is no longer recognised beyond the end of this year.
 
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