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Duratron® LSG PEI

Polyetherimide
Technical datasheet

The stock shape is also pre-assessed for biocompatibility for up to 24 hours contact with body and tissue according to USP VI and ISO 10993. Some color variations are also pre-assessed for use in wetted contact applications in bioprocessing.

Combining biocompatibility with peak performance, Duratron® LSG PEI exhibits outstanding mechanical, thermal, electrical properties, as well as very good resistance to hydrolysis and chemicals.

Duratron® LSG PEI components are also sterilizable by means of steam (autoclave), dry heat, EtO (Ethylene Oxide), plasma, and gamma- & X-ray irradiation. Due to these properties, Duratron® LSG PEI is an excellent candidate for applications in the medical and bioprocessing fields such as trial implants and radiotherapy applicators. 

Duratron® LSG PEI plastic stock shapes
Product Information

Material Properties

  • Pre-assessed on both resin and stock shapes for up to 24 hours contact with body or tissue according to USP VI and ISO 10993
  • Some color variations pre-assessed for wetted contact in bioprocessing
  • Unfilled ULTEM™ PEI base for biocompatibility on resin
  • Excellent resistance to hydrolysis and chemicals
  • Sterilizable via steam, dry heat, EtO, plasma, and gamma- & X-ray irradiation
  • Excellent mechanical, thermal, & electrical properties
  • Excellent dimensional stability

Available Geometries

Duratron® LSG PEI stock shapes encompass a range of standard sizes in the following geometries: Rod, Plate

Rod
Plate

Available Colors

Duratron® LSG PEI stock shapes come in the following colors: Amber-Translucent, Black, Blue

Regional Availability

Availability of products, shapes, and colors may differ by region.

Resin Note

Ultem® is a registered trademark of SABIC.
Application & Testing Information

Pre-assessment Testing

Duratron® LSG PEI carries the following compliances:

  • ISO 10993-5 and USP <87> Cytotoxicity
  • ISO 10993-10 Sensitization
  • ISO 10993-10 and USP <88> Intracutaneous Reactivity
  • ISO 10993-11 and USP <88> Acute Systemic Toxicity
  • USP <88> Implantation Test
  • USP Class VI (conclusion of three of the above ISO 10993 and USP <88> tests)
  • ISO 10993-4 Human Blood Compatibility
  • USP <661> Physiochemical Testing
  • Animal Free Origin

Please note: In some cases, different color variations of a material grade carry different approvals. Please see product documentation for details.

Intended Use

Duratron® LSG PEI is only intended for applications in which the duration of contact with human body tissue is limited to less than 24 hours, or wetted contact applications in bioprocessing.

Furthermore, LSG materials are not intended for use in the manufacture of medical devices that will be permanently implanted in the body, nor are they intended for use in life-sustaining medical devices.

Documentation

For further regulatory documentation and absence declarations, please visit the regulatory page.