Why Ultem
Ultem is the brand designation for the polyetherimide (PEI) family of polymer materials. SABIC Innovative Plastics is the sole producer, and supplies numerous grades that serve a variety of processes and applications globally.
Because of its unique molecular structure, Ultem PEI can be melt-processed by injection molding and extrusion, while certain polyimides cannot. In its natural form it is transparent amber, and is available in transparent and opaque colors.
What are the Performance Features of Ultem?
Ultem is recognized for its rigidity and stability even at temperatures over 200oC. The high strength polymer also resists creep, or deformation under load over time. Carbon and glass fiber reinforced grades further enhance the material’s rigidity. Ultem PEI also meets the flammability and smoke generation requirements for aircraft applications, and has the highest dielectric strength among thermoplastics.
What Properties of Ultem are Beneficial for Medical Devices?
Ultem PEI imparts high rigidity and good impact resistance to medical devices. It also maintains its properties after repeated cycles in all common sterilization methods, and resists chemicals and sanitizing agents commonly used in healthcare.
Does Ultem Comply with ISO 10993 Biocompatibility Standards?
Genesis Medical Plastics offers machinable stock shapes in two Ultem PEI (polyetherimide) medical grades that have ISO 10993 biocompatibility for devices in limited contact with bodily fluids and tissue:
- Ultem HU 1000 PEI is intended for a wide variety of sterilizable applications and meets FDA biocompatibility requirements for devices exposed to bodily fluids for up to 24 hours. Typical applications that capitalize on the high-performance medical polymer’s tolerance to common sterilization methods include repeat-use surgical instruments, instrument handles and drug delivery devices.
Note: A low viscosity grade of Ultem HU 1000 has been developed for injection molded applications that are designed with thin wall sections or intricate precision features. Designated Ultem HU 1010, its properties and biocompatibility compliance are consistent with the HU 1000 grade.
- Ultem HU 1004 PEI meets 10933 biocompatibility requirements for devices exposed to bodily fluids and tissue for up to 29 days. It retains its properties and color after repeated sterilization cycles in all common equipment and maintains ductility and color stability after exposure to an extreme test level of 300 cycles in STERRAD NX, STERRAD 100NX plasma and AMSCO V-PRO vapor Applications include invasive procedure devices that may be left in place for periods of less than 30 days.
In addition to their tolerance to STERRAD systems, Ultem HU 1000 PEI and Ultem HU 1004 PEI exhibit good retention of color and physical properties after repeated sterilization cycles in these processes:
- Vaporized Hydrogen Peroxide gas plasma (VHP) >300 cycles
- Steam autoclave at 134°C >1000 cycles
- Gamma radiation, electron beam, and X-ray
- Ethylene Oxide (EtO)
- Ultraviolet C (UV-C) 5 kJ/cm2 dose
Availability
Genesis Medical Plastics offers extruded stock shapes and precision machined components in Ultem HU 1000 and Ultem HU 1004 on a made-to-order basis.
These two grades as well as a low viscosity version of HU 1000 designated Ultem HU 1010, and 30% glass fiber reinforced Ultem HU 2300, are also available as injection molded parts. All meet ISO 10993 biocompatibility standards.