The “use-by“ time limit - Terminology discrepancy - MEDDEV & HS

twanmul

Involved In Discussions
#1
Hi there,

I was reviewing MEDDEV2.2/3rev3 for various reasons and stumbled across this terminology for "use-by:"
The “use-by“ time limit relates to the period before the first use of the device. It does not relate to the number or period of subsequent uses (the “lifetime“ of the device).

This is different from my understanding of use-by and is in contrast with the definition of the use-by symbol within ISO15223:2016 section 5.1.4:
Title of symbol: Use-by date
Description of symbol: Indicates the date after which the medical device is not to be used.
Requirements: This symbol shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown.


This is an interesting difference and I'm more inclined to ignore the MEDDEV definition as a result. Do others agree that I'm better sticking with the HS definition (I figure as long as I'm consistent in my terminology, then it should be fine)?
 
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