What are the changes in the BS EN 1041:2008 recently published amendment

G

gitgiv

#1
Hi all!

Does anyone know what are the changes in the BS EN 1041:2008 recently published amendment (A1:2013)? :confused:
I understand the 2008 version is still valid, but I would like to prepare myself...

Thanks!
gitgiv.
 
Elsmar Forum Sponsor
#2
Can't find anything exact (why do they make it so hard?) but what I have found is that A1 amends clauses 2, 4.2, 5.1 and the bibliography.

Cl. 2 Normative references - 1st listed reference deleted (EN 980)

Cl. 4.2 Units, symbols and colours - Not sure but I think it just removes reference to EN 980

Cl. 5.1 Addition of clauses 5.1.1 and 5.1.2
5.1.1 Safe and effective use of the device
5.1.2 Address required under the MDD
(I don't have any further detail there)

Bibliography - Don't know but it may just be to update the listings for the directives
 
#4
I think that the amendment is available on it's own from the Dutch standards body for 15euro (www.nen.nl). I can't say exactly what that gives you as I can't read Dutch! But it is in English.

It is worth remembering that EN 1041 is a CEN standard so is purely European in it's outlook. As such, it really just transposes the applicable Essential Requirements from the directives.
 
C

Carrie O

#5
I agree with this assessment.

The thing that frustrates me is that the Annexes still list EN 980.

It appears that this version is supposed to be published in the official journal in March. As of now I do not see a harmonized standard for symbols as EN 980 was withdrawn and ISO 15223-1 was never added. This is a big deal if we have to add definitions for our previously acceptable symbols to all of our IFUs.

Does anyone have any idea of when we might expect to see a harmonized standard for symbols?

Can't find anything exact (why do they make it so hard?) but what I have found is that A1 amends clauses 2, 4.2, 5.1 and the bibliography.

Cl. 2 Normative references - 1st listed reference deleted (EN 980)

Cl. 4.2 Units, symbols and colours - Not sure but I think it just removes reference to EN 980

Cl. 5.1 Addition of clauses 5.1.1 and 5.1.2
5.1.1 Safe and effective use of the device
5.1.2 Address required under the MDD
(I don't have any further detail there)

Bibliography - Don't know but it may just be to update the listings for the directives
 
#6
Does anyone have any idea of when we might expect to see a harmonized standard for symbols?
There is another thread on this somewhere on these forums - I can't remember where though!

My understanding is that there is one committee that removes superseded standards from the Official Journal (OJ) and another that adds new standards. So, the first committee removed 980 but the addition of 15223 was blocked by the usual objection that it doesn't necessarily cover all of the directives Essential Requirements. (This is what has driven so many standards to have additional Annex ZA, ZB and ZC).

I believe that 980 is considered to be still current, despite it not actually being on the list.

You mention that there will be an update to the OJ in March - can you let us know where this information comes from?
 

harry

Super Moderator
#7
There is another thread on this somewhere on these forums - I can't remember where though!

My understanding is that there is one committee that removes superseded standards from the Official Journal (OJ) and another that adds new standards. So, the first committee removed 980 but the addition of 15223 was blocked by the usual objection that it doesn't necessarily cover all of the directives Essential Requirements. (This is what has driven so many standards to have additional Annex ZA, ZB and ZC).

I believe that 980 is considered to be still current, despite it not actually being on the list.

You mention that there will be an update to the OJ in March - can you let us know where this information comes from?
New list (01-2013) of Harmonised Standards for The MDD published


BS EN ISO 15223-1:2012 replaces EN 980 - What is the effect of the change?
 
H

HAMEDD

#8
Can anyone tell me is it mandatory to follow EN 1041 and EN ISO 15223-1 or following requirement of MDD/93/42/EEC is enough.

Thanks in advance
 
#9
The use of any standard is always voluntary.

The medical device directive 93/42/EEC, transposed into national law, is the law! As such, it is the Essential Requirements of the MDD that must be met.

Usually, the most straightforward way to show that you have satisified the Essential Requirements is to use the applicable technical standards, including EN1041 (for Information Provided).

Note that, at the moment, it is EN 980 that is listed as the 'Symbols' standard.
 
H

HAMEDD

#10
Thank you so much PDF38 for your kind reply. It would be my pleasure if you give me your opinion on one more thing.I believe that EN 980 is withdrawn and replaced by 15223. But 15223 is not there on harmonized standard list. Is it ok if I consider EN 980:2008 and not 15223?
 
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