IEC 60601-1 Labels
TLP has multiple UL-recognized label constructions that are certified by UL to meet the marking durability requirements of IEC 60601-1. This standard is specific to the electronic medical device industry. It is internationally recognized, but there are European (EN), Canadian (CSA), and other region-specific variants with the same numerical designation (60601-1). UL partners with IEC to test labels to the durability of marking requirement of the standard.
Interested in learning more? Check out a quick Q&A with the TLP Engineering Team below.
IEC 60601-1 Labels from TLP
How do I know if I need a label that meets this requirement?
IEC 60601-1 is specific to electronic medical devices. If your product is marketed toward this industry, it may require testing and recognition to this standard. If your product has recognition to this standard, it needs a label that will fulfill the marking and durability requirements of the standard.
What are the advantages of a label recognized for this standard?
By having a label that is recognized for both UL 969 and IEC 60601-1 durability of marking, we can ensure that a label will be permanently effective in conveying safety information in the unique exposures of medical environments. IEC 60601-1 effectively ensures that the printed information will not degrade when exposed to common medical-grade cleaning agents, but does not address the permanence of marking through label adhesion and other factors. TLP’s UL-recognized label constructions that feature the IEC 60601-1 recognition add an additional level of assurance through UL 969 testing, which is specific to the application surface.
What type of testing is required to comply to this standard?
To fulfill the durability of marking requirement of IEC 60601-1, labels undergo a variety of tests. The primary test features rubbing the labels with water, methylated spirit, and isopropyl alcohol. This is meant to simulate wear that can be experienced in a medical environment.
What is the IEC?
IEC is the International Electrotechnical Commission. Like Underwriters’ Laboratories (UL), they develop product testing standards for various markets, and assess products to ensure conformance to those standards. The IEC operates similarly to the International Organization for Standardization (ISO), where UN-recognized nations work together to develop standards for the smooth and safe operation of business. While conformance to IEC standards is technically voluntary, it is expected for doing business with various organizations worldwide.
Also of Interest
- Custom Applications: Regulatory Labels from TLP
- Custom Applications: UL Labels
- Articles & Updates: UKCA Marking Regulatory Release
- Articles & Updates: MDR Compliance & Labels
- Articles & Updates: UDI Labels for Medical Devices
- Have a project to discuss? Contact TLP