Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 274

11.3 Labeling
All we need do now is put all of the symbols into a meaningful layout. I am afraid this is
down to your own thoughts and guidelines. However you can make life easy for yourself by
incorporating things that do not change on permanent artwork, and those that do change using
self-adhesive labels. At the end of the day the choice is yours. Certainly for small numbers the
expense of preprinting boxes and packages with standard livery is just not cost effective and
you will, almost certainly, be supplying Avery Inc. with good business. But as your numbers
increase, moving to standard livery is extremely useful.
When you start to print your labels you will quickly find that the cheapest labels in the high
street will not do. The adhesive used on cheap labels does not perform well and you will soon
have complaints from your end-users that labels have peeled off and, as a consequence, they
are unable to use your product. Self-adhesive labels are too important to scrimp on. The world
of labels is populated with a plethora of sizes. A good piece of advice is to pick one label
size (or at most two) that fits all of your products; this reduces inventory but also enables you
to design a standard layout. Pick an efficient and effective manner of printing. You should
not scrimp on printers either; the text, symbols, and any bar codes must be legible so a good
quality laser jet or one of the continuous thermal printers (e.g., Dymo TurboJet) is essential.
Once you have got this information labels are simple.
11.3.1 Outer Packaging Labels
The labels need not be beautiful, colorful, or able to win design awards. They only need
meet the labeling requirements for the given country, or state. Figure 11.14 illustrates a
typical simple label. It can be printed off with ease but only has three items of information
that change: those ringed. The more eagle-eyed of you will have noticed three deliberate
mistakes. The manufacturer symbol is missing (11.2.9), and the address is incomplete. The
REF symbol associated with the part number (11.2.6) is missing, and this label uses the
“old” nonsterile symbol.
Figure 11.14
Example label for EC: contains intentional errors.