Consultation: EN 980 still recognized by EU regulation?

Y

yzl1018

#1
Today, I download a new version of EU harmonised standard list. However, I find EN 980 still in this list, and EN ISO 15223 is not in this list. I can not understand why.Does it mean both of EN 980 and EN ISO 15223 recognized by EU medical device regulation? Or only EN 980 is recognized by EU medical device regulation?
Are anyone else can kindly show me your opinion?
Please reference the attachment for this new EU harmonised standard list.
 

Attachments

Elsmar Forum Sponsor
#2
Thanks for highlighting the new OJ list - it's been some time since they did the last one.

On the 980 / 15223 thing - last time (Jan 2013 I think) they published the list with neither standard shown. 980 was due to be removed, which one committee did, without knowing that another committee responsible for putting standards on the list was not prepared to endorse 15223 - so it wasn't added. Apparently 980 remained 'harmonised' even though it wasn't shown.

Now 980 is back on, so that presumably means that 15223 still has not been accepted by the relevant committee. This could be because they think that it 'does not necessarily satisfy all of the Essential Requirements of the directive'. This argument has forced many standards to have special European versions with the added Z annexes.

As this is a public place I shall 'hold my tongue' about my thoughts on the Z annexes!
 

rob73

looking for answers
#3
There are standards being issued at the moment (ISO 10079 is one that i have) that cite 15223-1 as a normative reference AND are due to be listed in eur-lex as harmonised.

Someone needs to pull their finger out of their b%tt and get this sorted.:deadhorse:
 
D

Devicediva

#4
So has anyone received direction from their Notified Bodies on what to reference in our Technical Files?
In our last recertification audit a few months ago, they didn't even look at it. I think because such a contentious subject. We still list EN ISO 15223.
Interested to hear what others might be seeing.:confused:
 

Marcelo

Inactive Registered Visitor
#5
Just to make things a little more clear: you can use any standard you want to show compliance with the essential requirements of the directives. The only difference of using an harmonized standard is that they give presumption of conformity with the requirements. If you use any other standard, you need to justify that it?s use achieves the same "safety level" as would be the case if you used an harmonized one.

EN ISO 15223 will be in the future the standard to use (it may take some more time due to the problem of harmonization) so it would be perfectly justifiable to use it as a solution, IMHO.
 
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