I don't with the IEC 60601 series very often, but it comes up in my risk management work. Keeping the versions organized in my mind, as a result, is often a problem.
In this case, the most recent question relates to the international version as compared to the EU harmonized version.
People often refer to these standards by edition number rather than by the year of publication as is common with other standards.
I believe that when people say IEC 60601-1 Edition 3.1 this is a synonym for EC 60601-1:2005/AMD1:2012. When I checked the IEC website there is a note that says, "The contents of the corrigendum of July 2014 have been included in this copy."
However, the IEC webpage has a summary table. One of the entries is Edition which says 3.0.
Looking at the history tab there are two entries listed as Edition 3.1
IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012
IEC 60601-1:2005+AMD1:2012 CSV
I believe CSV mean consolidated version.
Looking at the TRF table, I infer that current version is IECEE TRF 60601-1K:2015.
My first question deals with the proper documents for, what people call, Edition 3.1. Are they IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012 and IECEE TRF 60601-1K:2015?
When I look at the table of standards harmonized to the MDD it appears the current harmonized standard is EN 60601-1:2006/A1:2013.
With the exception of potential Z Annexes is EN 60601-1:2006/A1:2013 the same as IEC 60601-1:2005+AMD1:2012 CSV?
Because the harmonization process is behind schedule, is there an EU version that is not yet harmonized?
------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------
Original Message:
Sent: 24-May-2018 05:09
From: Claus Andersen
Subject: IEC 60601-1 3.1 edition
Hi Sheeman,
For EN 60601-1 ed. 3.1 the date of cessation of presumption of conformity of superseded standard was 31/12-2017.
As such, per 01/01-2018 compliance with ed. 3.0 is not sufficient to provide presumption of compliance, as that version of the standard is no longer harmonised.
It is voluntary to use harmonised standards to demonstrate compliance with the essential requirements of the applicable EU directives for CE marking. It is however the simplest approach, as compliance with a harmonised standard allows the manufacturer to presume compliance with essential requirements covered by the scope of the standard.
If through your risk management activities and other design verification / validation activities, you can demonstrate that the product is in compliance with all relevant essential requirements you can do that without applying a harmonised standard. It is, however up to the manufacturer to document and argue why the applied methods are adequate and sufficient.
So yes, compliance with ed. 3.1 is optional, if your applied methods for demonstrating compliance are justified.
So, I would recommend compliance with ed. 3.1 as the simplest approach.
If you have a notified body involved in the authorisation proces, I would recommend to agree on your approach with them up front. As compliance with harmonised standards is most often the least cumbersome route.
Let me know if you need additional clarification.
------------------------------
Claus Rømer Andersen
Hørsholm, Denmark
claus@roemerconsulting.dk
Original Message:
Sent: 23-May-2018 16:56
From: Sheemah Kazi
Subject: IEC 60601-1 3.1 edition
Hi Everyone,
I know the compliance with IEC 60601-1 edition 3.1 was effective from Jan 1st, 2018 for Europe. My question is the compliance optional?
Thanks,
Sheemah
------------------------------
Sheemah Kazi
Concord CA
United States
------------------------------