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

[orangeisenergy]

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!

 

[Pads38]

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.

 

[orangeisenergy]

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...

 

[Pads38]

https://www.evs.ee/products/evs-en-12322-1999

https://www.evs.ee/products/evs-en-13612-2002

Note also that to purchase both standards from that site would be less than 20euros. They are in English.

Opt for the slightly more expensive multi-user licence for non-restricted use.