J
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
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