IVDs: Expiry Date on internal product standards

A

AbsoluteBeginner

We are a company develope and produce real-time PCR. We will sell our prospective CE-marked products including positive control material. For this material, we have to ensure a documented continuous traceability to the original positive material (i.e. higher concentrated). We call it according to DIN EN ISO 17511 for example ?working standard? and ?product standard?, which we will only use for internal handling. We do not put these standards on the market.
Now our question: Do we have to state the date of expire on the (internal) label or is it sufficient to state the date of manufacture?


Thanks in advance!!!:thanks:
 

Stijloor

Leader
Super Moderator
A Quick Bump!

Can someone help with this question?

Thank you very much for lending a hand!
 
K

Karen747

I have a question about 17511:

If there is not an international reference standard available how can you claim compliance to this standard?

Thanks in advance
 
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