Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 271

11.2.4 Sterility
This has a number of symbols; they all depend on the method of sterilization ( Figure 11.4 ).
The symbols look the same; it is the last letter that differs.

11.2.5 Use by Date
Please note that dates have a very specific format. They always go year - month - day. Hence
1st February 2012 would be 2012-02-01 ( Figure 11.5 ). Stick to this format and never ever
miss the zeroes!

11.2.6 Lot Number/Batch Number
In this case XXXXX represents the unique lot number (or batch number) for this device
( Figure 11.6 ). It is the single piece of information that ensures traceability .

11.2.7 Catalog Number/Part Number
Here, XXXXX is the part number for your device ( Figure 11.7 ). It helps with traceability, but
also for reorders!

Sterile R Sterile Sterile

EO

Figure 11.4
Sterility symbol: (a) irradiation; (b) ethyl oxide; (c) steam.

Figure 11.5
“Use by” symbol: two acceptable forms.

LOT

LOT XXXXX

XXXXX

Figure 11.6
Lot number/batch number symbol: two acceptable forms.

XXXXX REF

REF

XXXXX

Figure 11.7
Part number/catalog number symbol: two acceptable forms.