Medical device labeling materials require a level of durability, safety and performance beyond that of your run-of-the-mill labels.
The national standard for safety testing of electrical medical devices is IEC 60601-1. It defines the general requirements for basic safety and essential performance. Within this standard, labeling is deemed a critical component of a medical device.
All information for safe installation, use, storage, servicing, and maintenance of the device must be provided to the user. Some of this information is safety-critical.
IEC 60601-1 has Durability of Marking requirements within the guideline:
• Requires that both internal and external markings be clearly legible and that all required external markings be durable
• Specifies rubbing external markings with water, methylated spirit, and isopropyl alcohol
• Using a cloth rag, each substance is to be rubbed on the external marking for 15 seconds
• The test requirements include verifying that the external markings are clearly legible and that labels do not fall off or curl after the rub treatments
National Custom Printing offers UL label materials that meet the above requirements on typical substrates used in medical devices. . Each of these specs has identified flexo inks and TT ribbons for use in this application to meet IEC 60601-1. Our durable specs that UL-certified and substrates tested:
• Aluminum • Glass • Acrylic Powder Paint • Epoxy Powder Paint • Polyester Powder Paint • Acrylonitrile Butadiene Styrene •