Suggested process to show compliance for this 820.120(a) for Label Integrity

sreenu927

Quite Involved in Discussions
#1
Hi All,

As per 820.120
Each manufacturer shall establish and maintain procedures to control labeling activities.
(a)Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.

So for labels on big instruments like thermal cyclers, what is the suggested process to show compliance for this 820.120(a).

I can think of "peel test" for the labels.
I am not sure whether this is the correct one or not.
any suggestions?

Thanks,
Sreenu
 
Elsmar Forum Sponsor
#2
IEC 60601-1 (the FDA recognised standard for medical electrical equipment) has a test for label integrity. This calls for rubbing with a cloth without undue pressure, for 15 secs each with the cloth moistened with i)water ii)isopropanol iii)(m)ethanol. The label is afterwards to be legibly and without peeling.

Elsewhere it asks for the risk of poor marking legibility due to multiple cleaning operations to be considered. Which would be dependent upon your equipment type / use location / lifespan etc. And, I guess, for a thermal cycler, the "Caution Hot Surface" label needs to withstand multiple heat cycles ;-)
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi All,

As per 820.120
Each manufacturer shall establish and maintain procedures to control labeling activities.
(a)Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.

So for labels on big instruments like thermal cyclers, what is the suggested process to show compliance for this 820.120(a).

I can think of "peel test" for the labels.
I am not sure whether this is the correct one or not.
any suggestions?

Thanks,
Sreenu
Hi,

I'd start by capturing "the customary conditions of processing, storage, handling, distribution, and where appropriate use". Then analyse all these and identify the mechanisms threatening (a) label fixation to the device (if it's not a direct print), and (b) label contents legibility. Your testing should address those mechanisms - for instance, a paper sticker is not the same as a riveted metal nameplate. Don't forget to address shelf life, use life, extreme environmental conditions, cyclic exposure etc.

Analysis comes first, then testing. Oh, and all this better be well documented.

Cheers,
Ronen.
 
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