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

renenatasha

Involved In Discussions
#21
Thanks for the info, AimeeC. But does that mean it's considered a harmonized standard?

Cos according to Annex ZA in EN ISO 15223-1:2012, it's stated, "Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, ..., a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations." And I don't see that cited in the C 262/6 - Office Journal of the European Union dated 30.8.2012.

Could anyone else clarify PLEASE? Thanks!
 
Elsmar Forum Sponsor
U

usability

#22
EN 980:2008 was deleted and EN ISO 15223-1 was not cited in the official journal dated 24.1.2013 C_22/7.
Should we delete EN 980:2008 from our applied harmonized standard list of the technical file as soon as possible?
Tkanks
 
G

gertg

#23
EN ISO 15223-1:2012 has been refused by the European Commision due to deficiencies in the standard (thanks: Cenelec & ISO) , en de superseded EN 980:2008 remains VALID, and will soon be re-introduced into the list of harmonised standards with a corrigendum (i suppose) according to a message i got from the EC.

(to be continued)
 
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Ronen E

Problem Solver
Staff member
Moderator
#24
EN ISO 15223-1:2012 has been refused by the European Commision due to deficiencies in the standard (thanks: Cenelec & ISO) , en de superseded EN 980:2008 remains VALID, and will soon be re-introduced into the list of harmonised standards with a corrigendum (i suppose) according to a message i got from the EC.

(to be continued)
I guess that in EC terms "soon" means in about 6 months...? :)
 

Marcelo

Inactive Registered Visitor
#25
I guess that in EC terms "soon" means in about 6 months...?
Probably :p

Anyway, I got a confirmation today that CEN/CLC/TC3 is creating a solution to the EC objection and it will be implemented in a short notice, so we may still see only EN ISO 15223-1 instead of a return of EN 980.
 
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M

MPiska

#26
EN ISO 15223-1:2012 has been refused by the European Commision due to deficiencies in the standard (thanks: Cenelec & ISO) , en de superseded EN 980:2008 remains VALID, and will soon be re-introduced into the list of harmonised standards with a corrigendum (i suppose) according to a message i got from the EC.

(to be continued)
Do you have any more info on this?
Particularly on EN980 not being withdrawn.

Thanks,

MP
 
G

gertg

#27
No, that is what the EC replied me:

[FONT=&quot]European Commission[/FONT][FONT=&quot]
[/FONT]
[FONT=&quot]Directorate-General for Health and Consumers[/FONT][FONT=&quot]
[/FONT]
[FONT=&quot]Unit B2 - Health technology and Cosmetics

[/FONT]
 

Sam Lazzara

Trusted Information Resource
#28
Probably :p

Anyway, I got a confirmation today that CEN/CLC/TC3 is creating a solution to the EC objection and it will be implemented in a short notice, so we may still see only EN ISO 15223-2 instead of a return of EN 980.
Hi Marcelo,
Did you mean to say EN ISO 15223-2? (not -1?)
 
J

jruss14

#30
So, which standard should I site on a new technical file for a new device? EN 980 or EN ISO 15223-1? Would it be ok to site just ISO 15223-1 or is this dependent on the NB involved? Thanks for the feedback!
 
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