Tested to UL/IEC 60601-1 and UL/IEC 61010-1
Polyonics LML materials meet the performance requirements of the FDA Unique Identification (UDI) initiative for class II and class III medical devices.
The materials fully comply and have been tested to the UL/IEC 60601-1 (3rd edition) as well as the UL/IEC 61010-1 (3rd edition) for coating durability.
The LML materials use polyimide (PI) or PEEK films, renowned for their chemical resistance and dimensional stability in high temperature and harsh environments.
Polyonics coats the films with durable, cross linked polymer coatings that allow high precision ablation by a wide variety of
YAG, fiber, CO2 and UV lasers to produce high contrast linear and 2D barcodes and alpha numeric characters.
The LML materials include low surface energy PSAs for strong bonding to typical medical device plastic surfaces.
Polyonics XF-671 white polyimide
and XF-684 off white PEEK LML
materials for UDI applications
Flexible Alternative to Direct Part Marking
The Polyonics LML materials are designed to optimize the direct part marking (DPM) by allowing manufacturers to capture QC and test data by directly marking the labels in process. In addition, using LML materials in concert with DPMs helps simplify the rework process by allowing relabeling and repositioning of UDI labels.
The Polyonics LML materials are designed to optimize the direct part marking (DPM) by allowing manufacturers to capture QC and test data by directly marking the labels in process. In addition, using LML materials in concert with DPMs helps simplify the rework process by allowing relabeling and repositioning of UDI labels.
Increased Durability for High temperature Medical Device Labeling
Polyonics laser markable PI and PEEK label materials offer medical device manufacturers dramatically increased durability compared to PET and acrylic LML materials. The LML materials provide higher temperature spectrums, expanded chemical resistances plus they don’t use ink, the weak link with traditional thermal transfer printed labels. The Polyonics label materials will provide medical device manufacturers with,
Polyonics laser markable PI and PEEK label materials offer medical device manufacturers dramatically increased durability compared to PET and acrylic LML materials. The LML materials provide higher temperature spectrums, expanded chemical resistances plus they don’t use ink, the weak link with traditional thermal transfer printed labels. The Polyonics label materials will provide medical device manufacturers with,
Features and Benefits
- Approved UDI/medical device tracking for high temperatures and harsh environments
- Resistance to high temperatures, abrasion and harsh chemicals (automotive, electronics and aerospace)
- Resistance to autoclave/sterilization heat and humidity (3300+ cycles)
- Resistance to HIP detergent wash processes (1000+ cycles)
- Compliance with Title 21 – Food and Drugs, Chapter 1 – FDA Subchapter H – Medical Devices, Part 801 Class II Multi-use UDI Labeling
- Tested to the UL/IEC 60601-1 and UL/IEC 61010-1 (both 3rd editions) for UDI label coating durability.
- More durable than thermal transfer printed labels and PET and acrylic LML labels