Proper equipment labeling is an important part of a health facility’s risk management plan. Each piece of equipment, from IV pump to a hospital bed, requires some form of labeling. The message the label carries is dependent on the function of the device.
While hospitals, doctor’s offices, and other healthcare facilities are under constant pressure to meet governmental standards, most labeling falls to the equipment manufacturer.
Medical equipment manufacturers must make sure their devices meet the stringent standards of their industry. Before a piece of medical equipment is approved for sale, it undergoes testing and regulation reviews. Part of that approval process includes making sure the device is properly labeled with UL 969 approved medical device labels.
Medical Device Classes
The required labeling for a medical device is determined by its class:
Class I – Class I devices pose a negligible safety risk to patients and service providers. Stethoscopes and forceps are Class I devices.
Class II – These devices are subject to FD&CA, standards, as specified in Section 514. Endoscopes and surgical lasers are Class II devices.
Class III – These are typically life-support apparatuses, which must be approved for sale to patients and medical facilities. A cardiac pacemaker is a Class III device.
The use of UL-approved labels and especially UL 969 certified labels will ensure the label stays in place and stands up against heavy usage or possible malfunction.
Why is UL Certification Important in Medical Labeling?
UL is an independent safety certification company. UL trains, tests, and certifies individuals and groups in the labeling industry.
UL has been offering these services for more than four decades. UL tests labels for the medical industry under the UL 969 PDGQ2 certification to ensure that they meet performance standards, adhere to regulations, and satisfy the customers’ needs. UL 969 approved labels will not curl, shrink, or fade due to conditions such as exposure to sunlight, changes in temperature, high humidity or contact with solvents or cleaning solutions.
Types of Medical Device Labels
The actual label type depends on the function of the device. For example, x-ray machines require a warning label specifying the necessary safety practices that need to be observed. Another example, medical membrane switches can be customized to particular devices, such as equipment monitors and IV pumps. Membrane switches offer a NEMA 4 seal that keeps moisture from penetrating into the device.
Other common labels in the medical device manufacturing industry:
- Back Panel Labels
- Graphic Overlays
- FCC labels
- ID Labels
At Adhesa Plate, you can rest assured that our UL recognized and UL 969 certified labels will meet your needs and stand the test of constant use. We are experts in helping our clients determine the best labels and customized solutions. Adhesa Plate will help your company succeed in the medical equipment marketplace, where 1st impressions are so critical.