EN ISO 12322:1999 vs. EN ISO 13612:2002 - Which to use

O

orangeisenergy

#1
Hi-
We are looking to pursue a CE mark for an Annex III culture media IVD. So, in looking for the EU recognized standards we need to use/reference, I see that there are 2 for performance evaluation/criteria:

EN ISO 12322:1999 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media

EN ISO 13612:2002 Performance evaluation of in vitro diagnostic medical devices

I am looking for guidance for utilizing both of these standards, or ust the one specific to culture media (EN ISO 12322)? I have not read either, and cannot find a good synopsis of them before I purchase them- so I wanted to check here first... Thanks!
 
Elsmar Forum Sponsor
#2
The standards to apply are those that are published in the Official Journal of the EU.
For the IVDD see here:-
https://ec.europa.eu/growth/single-...ed-standards/iv-diagnostic-medical-devices_en

Note that neither of the standards you have identified are ISO standards. Instead they are CEN standards.

Most online sources of standards have a 'preview' facility that allows you to see the first few pages of a standard. This is useful as you can view the 'Scope' of a standard to judge whether or not it is applicable to your case.
 
O

orangeisenergy

#3
The standards to apply are those that are published in the Official Journal of the EU.
For the IVDD see here:-
https://ec.europa.eu/growth/single-...ed-standards/iv-diagnostic-medical-devices_en

Note that neither of the standards you have identified are ISO standards. Instead they are CEN standards.

Most online sources of standards have a 'preview' facility that allows you to see the first few pages of a standard. This is useful as you can view the 'Scope' of a standard to judge whether or not it is applicable to your case.
I can't find a site that will let me preview any of it :( if you know of one, please let me know!
What is the significance that it is a CEN Standard? It is also an ISO standard, as ISO is in the title of it, correct?
The link you gave is where I found both of these standards, and am not sure which or both I should buy and apply...
 
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