ISO 18223-2 Temperature symbol in the Legend table in the Instructions for Use

SANE

Starting to get Involved
#1
Dear All,
a tedious discussion in our company: A legend as part of each IFU explains the symbols used in the IfU and on the labels. Among the symbols listed is also the symbol for temperature range (To indicate the maximum and minimum temperature limits at which the item shall be stored, transported or used ).
On the labels, this symbol is completed with the lower and uppper temperature limits requested for the IVD kit. In the legend of the IFU, a table with just the symbol is shown, but without addition upper and lower temperature. Next to it, the explanation "transport temperature" is written.
Now big argumentation has started that this is not ISO conform and in the legend the upper and lower exact temperature must be completed.
Can somebody tell me whether this is really requested and where it is requested in the ISO?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I don't think you'll find it stated either way anywhere, but why does it matter?... One way or the other. The purpose is to explain the meaning of the symbol where you have more room to do so.
 

SANE

Starting to get Involved
#3
Dear Ronen,
I agree. In principle it does not matter and it would not hurt if there will not be so many language versions. We do not have a QM software, so everything needs to be done manually if we have to change something what is not really needed.
I focused on the symbol and the explanation in the legend table. However, I was told, that it is a mistake since max and min is not in the table together with the symbol and now our QM lady says, a CAPA needs to be filed since it is a mistake and all the language versions are wrong. I cannot follow this argumentation why this is a mistake without the temperature in this small symbol glossary.
If it does not matter, then there would also no need to have the CAPA because of missing temperatures in the legend table. Our QM lady insists on the addition. For me, this alone does not justify a CAPA.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Our QM lady insists on the addition.
Then it should be her burden to point at where this is explicitly and officially required. Without such indication it would be a terrible waste of resources on the whim of one person.
I wonder how your management sees it.
 

SANE

Starting to get Involved
#5
Dear Ronen,
thanks a lot. I will tell the Management. It is not her burden. She is a burden ;-).
So, it is good to know that I am not completely wrong. Mistakes can happen and I want to learn and improve myself.
 
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