Performance Label Materials

Laser Markable Label Material for UDI Applications


Polyonics XF-671 white polyimide and XF-684 off white PEEK LML materials for UDI applications


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.

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.

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,

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. Download complete UDI test report.
  • More durable than thermal transfer printed labels and PET and acrylic LML labels
MH19503

Product Selection

Click on product number to download technical bulletin


Product
Film/face
Adhesive2
Total Thickness
Applications
Description
XF-670
25µm Black Anitstatic Polyimide
25µm High Temperature, Low Surface Energy Acrylic
66µm
Harsh Environment Tracking. Automotive Under-the-Hood1 , aerospace3, IUID, UDI Low Surface Energy (LSE) Materials, Plastics, etc. High temperature & Harsh Chemical Resistant ESD Black Top Coat. Low outgassing, halogen free, REACH and RoHS compliant. UL/IEC 60601 and 61010 compliant.
Min. Application Temperature: 32°F (0°C)
Temperature Range: -40° to 260°C
XF-671
25µm TruWhite™ Polyimide
25µm High Temperature, Low Surface Energy Acrylic
66µm
Asset tracking in high heat, steam and humidity. UDI applications involving repeated autoclave sterilization (>3300 cycles) and detergent washing (<500 cycles) of medical devices made from  low surface energy materials High temperature, white top coat resistant to steam, chemicals, water, etc. Halogen free, REACH and RoHS compliant
Min. Application Temperature: 32°F (0°C)
Temperature Range: -40° to 260°C
XF-672
25µm TruWhite™ Polyimide
25µm High Temperature, Low Surface Energy Acrylic
66µm
Harsh Environment Tracking. Automotive Under-the-Hood1 , aerospace3, IUID, UDI LSE Materials, Plastics, etc. Low Soot. Abrasion Resistant white top coat. Low outgassing, halogen free, REACH and RoHS complienat. UL/IEC 60601 and 61010 compliant.
Min. Application Temperature: 32°F (0°C)
Temperature Range: -40° to 260°C


1LML materials can be configured with glassine or PET liners. Silicone PSAs are also available for ultra-High temperature applications.

3Download a complete aerospace chemicals, UV and abrasion test report.

To learn more about these unique laser markable materials, call our technical experts at (603)352-1415 or request information



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Laser Markable News

Polyonics Delivers High Temperature and Chemically Resistant Polyimide Laser Markable Label Materials for UDI Medical Device Applications

Polyonics introduces a family of high temperature and chemical resistant polyimide laser markable label materials that have been tested to the UL/IEC 60601-1 and 61010-1 coating durability requirements and fully comply with the new FDA sponsored UDI (unique device identifier) initiative.

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