Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012

Mark Meer

Trusted Information Resource
#1
With regards to RoHS technical documentation and RoHS Directive 2011/65/EU:

I notice that on sites to purchase standards, the harmonised standard EN 50581:2012 (Canceled) is listed as withdrawn.
It is superseded by EN 63000:2018, however at present this is not listed as a harmonised standard.

Questions:
  1. Does anyone know if there are substantive differences between the old EN 50581:2012 and new EN 63000:2018?
  2. From my understanding, EN 50581:2012 is expected to remain a harmonised standard until 2024. Can anyone confirm?
 
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YellowQCPro

Starting to get Involved
#2
Hi Mark,

I too have questions regarding standards and their applicability when they are not harmonized. I think that you can purchase tracked changes from the BSi standards page here:

BS EN IEC 63000:2018 - TC - Tracked Changes. Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

But my question is....

How do you determine if you need to be compliant to EN vs. EN ISO or even BS EN ISO?

My company has manf. facilities in US and EU. The NB is BSi.

If a standard is harmonized, is that considered state of the art?
Or do you typically purchase the standards that are applicable in your EU manf. facility (i.e. EN ISO)?
 

planB

Trusted Information Resource
#4
YellowQC Pro,

How do you determine if you need to be compliant to EN vs. EN ISO or even BS EN ISO?
Typically, the normative part of EN ISO standard versions are identical to the respective ISO standard. EN ISo versions may additionally contain the so-called informative "Z-Annexes" for e.g. medical-device related standards, where the standard clauses are related to the applicable MDD / AIMD and potentially in the future, to the applicable MDR section.

You cannot buy EN ISO standards from CENELEC, but you typically do from a national standards publishing agency, which publishes a BS EN ISO version in Britain, a DIN EN ISO version in Germany, an ÖNORM EN ISO version in Austria, etc. of an EN ISO standard.

Bottom line: whether you claim compliance to an ISO version of a standard or an EN ISO version typically does not make any difference with only a few exceptions, such as ISO 14971, risk management for medical devices.

If a standard is harmonized, is that considered state of the art?
This was the concept of "former" times when in the field of medical devices, state-of-the art standard revisions were quite regularly updated in the list of harmonised standards. Unfortunately, the harmonisation process has practically come to a standstill with only one recent harmonisation effort this year and none for the MDR as of today. Even this recent updated harmonisation is incomplete: e.g. EN ISO 10993-1:2009 is still the harmonised biocompatibility standard and has not yet been replaced by its related state-of the art update ISO 10993-1:2018, for which even no EN ISO version has been published yet.

Bottom line: notified bodies tend to expect compliance to state-of-the art standards, since a lot of harmonised ((medical device) standards are practically outdated. Try to get compliant to relevant published ISO standards with 1/2 -1 year after publication. This is, to my experience, a typical time-frame after which notified bodies start to expect compliance.

HTH,
 

Mark Meer

Trusted Information Resource
#6
Before purchasing the tracked changes for £164.00, I'd like to know that this is worthwhile purchase.

Are there significant changes? I trust that it is still acceptable to rely on supplier declarations of component parts?
 

planB

Trusted Information Resource
#8
Mark,

taking a sneak peek into the free standard preview forword Charlie kindly provided:

This document supersedes EN 50581:2012. IEC 63000 is based on EN 50581:2012. Given the widespread acceptance of EN 50581:2012, it was decided to keep the text as close as possible to the original document, and to limit the changes to the minimum necessary to reflect the latest status of international standardization in this area
and from the change notification of DIN's publisher Beuth:

Gegenüber DIN EN 50581 (VDE 0042-12):2013-02 wurden folgende Änderungen vorgenommen: a) Der Inhalt von EN 50581 wurde weitestgehend unverändert in eine Internationale Norm überführt.
it becomes obvious that the technical requirements remained unchanged.

HTH,
 

monoj mon

Involved In Discussions
#9
How much????

You can buy a legitimate multi-user licence copy for 13 Euro at EVS-EN IEC 63000:2018 (15.70 Euro for redlined)

BSI are one the most expensive places to purchase standards, and Estonian Standards are generally the cheapest
Thanks Charlie for this wonderful information, it is very helpful. Just wondering, are there any differences in content between the BSI version and EVS version!
 

planB

Trusted Information Resource
#10
monoj mon,

national (European) versions are typically identical in their normative part, may or may not be translated into the national language and contain a national foreword.

HTH,
 
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