Sterile Medical Device Labeling Requirments - ISO 1041

J

JimBa

#1
Hi,
If an active device is sold within a sterile barrier, and then packed in a carton, is there a requirment to have the expiry date on the inner sterile barrier as well as the outer carton. The device is sold per carton. Or is it OK to have it on the outer carton only. ISO 1041 distuinguishes between the 'sterile pack' and 'sales pack' but does not define these terms anywhere. Is it different for a non active medical device?

Cheers
 
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M

MIREGMGR

#2
Every requirement that I've worked with, requires that the sterility expiration date be on the primary packaging...the sterile barrier system, i.e. pouch/tray/whatever. Certainly that's the common interpretation of MDD Annex I Section 13.1.

User sites commonly remove sterile product-pouches/trays from cases or boxes and put those pouches/trays on shelves or in dispenser cabinets. Corrugated cardboard boxes are bioburden shedders and in many facilities are not considered to be compatible with handling of products that are to go into a sterile field, therefore they are removed from active-storage locations as quickly as possible. Thus an expiration date on the case or box is of limited relevance to end users.
 
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