Labels for medical equipment
Written by Oliver Stockton, Managing Director, CILS
We work with global medical equipment manufacturers who sell into the US market. These manufacturers need computer printable labels that are durable and meet their durability requirements.
Labels within the medical equipment and medical device industry must be permanent enough so that they cannot be removed without the aid of a tool or appreciable force to ensure that they remain affixed in the end-use environment for the life of the product.
The printed markings on the label must also be durable enough to remain clearly legible during the expected life of the equipment.
General durability tests that medical equipment labels must satisfy include being able to resist a rub test completed by hand for 15 seconds per substance using a cloth soaked in distilled water, ethanol (96%) C2H60 and Isopropyl alcohol C3H80 as well as abrasion and handling.
To help our customers meet the labelling requirements we must consider 3 things:
The label will most likely be applied to the outside of the equipment therefore, the label material will need to be durable enough to survive the environment of the equipment. Metalised Polyester is often used as it offers the right level of durability and is the modern alternative to metal rating plates.
Metalised Polyester resists wear, abrasion and the chemicals that most medical equipment comes into contact with as outlined above.
A gloss or satin finish is ideal as it makes it easy to wipe the labels clean.
For longevity and permanence for the lifetime of the medical equipment, it is important that the label has a permanent solvent acrylic adhesive matched to the surface the labels will be stuck to.
Medical equipment is manufactured with a variety of surface finishes, so it is important that the label adhesive is appropriate for the specific application surface in order to ensure the permanence of the label.
Polyester labels are available with many different adhesives and if an incorrect adhesive is specified the label may bond well to start off with but may deteriorate with age. Solvent acrylic adhesives get better with age not worse!
For example, if the label needs to be stuck onto a lightly or heavily textured surface, the most appropriate adhesive would be a high tack permanent solvent acrylic adhesive. If the surface has a tight radius then a faster curing solvent acrylic permanent adhesive label would be better suited.
If the adhesive has been correctly specified for the surface of the medical equipment, then the label will stay affixed for the life of the equipment and will only be able to be removed using a tool or appreciable force.
A key part of having a reliable label that can be used with medical equipment is that it has clarity, resolution and legibility of markings and important data on the equipment.
UDI and other important data, whether printed or handwritten, must remain legible and stuck on the medical equipment even when the label comes into contact with water and other solvents.
The printed design and data will need to resist the rub test as mentioned above to ensure the data legibility of the label print throughout the life of the equipment.
One option is to print the labels yourself with a thermal transfer printer and the correct solvent resistant ribbon.
Another option would be to opt for a label fully printed by the label manufacturer to your exact requirements ensuring the clarity, resolution and durability of the print meets the required standards. In cases where ultimate durability is required, an added protective layer can be applied to the pre-printed data so that it can resist the harshest of environments for the lifetime of the equipment.
If you would like a very professional looking label that features your company loge etc, but would like to print the labels yourself, a partially printed label can be provided and you only need to add your label data.
How can we help?
CILS have a large range of materials and print options available to suit medical equipment applications that meet the majority of standards that manufacturers must abide by. We work on a consultative approach meaning we collaborate with you to understand the exact end-use environment of the labels to make sure our labels meet your requirements.
We have a team of specialists on hand that will help you specify the correct medical equipment label so that you can be confident the data will remain legible when you need it.
Get in touch to discuss how we can help you find a label that is right for you.