Ultem HU 1004 – Comprehensive Overview
Ultem HU 1004 is a proprietary blend of polyetherimide (PEI) with another high-performance polymer. It affords performance benefits that the individual polymers do not provide. The polymer formulation meets biocompatibility compliance requirements for use in implanted devices in contact with bodily fluids and tissue for up to 29 days.
Although it is a polymer blend, Ultem HU 1004 retains the amber tint of natural Ultem PEI, and is available in a range of transparent and opaque colors.
Is Ultem UH 1004 Compliant with ISO 10993?
ULTEM HU1004 resin complies with ISO 10993 biocompatibility requirements for contact with bodily fluids and tissue for up to 29 days, and has passed the following tests:
- ISO 10993 Part 5 – Cytotoxicity
- ISO 10993 Part 6 – Intramuscular Implantation
- ISO 10993 Part 10 – Irritation and Skin Sensitization
- ISO 10993 Part 11 – Systemic Toxicity
This information is a summary only. Detailed information on ISO 10993, ASTM and USP tests conducted on Ultem HU 1004, as well as Master File Access, should be obtained directly from Sabic. www.sabic.com
What Physical Property Benefits Does Ultem HU 1004 Offer for Medical Devices?
The proprietary HU 1004 polymer blend has higher impact resistance than standard Ultem PEI grades. Its rigidity or flexural modulus approaches the levels for which Ultem PEI is recognized. Both properties are performance benefits for surgical instruments and other devices.
Ultem HU 1004 maintains its physical properties very well after repeated cycles in all common sterilization methods. It also exhibits color stability in color-coded devices after repeated sterilization cycles.
Is Ultem HU 1004 Compatible with STERRAD NX and AMSCO V-PRO sterilization systems?
Ultem HU 1004 PEI is notable for its tolerance to STERRAD NX, 100NX plasma and AMSCO V-PRO vapor systems, where it retains a high level of its original impact strength and ductility after an extreme 300 cycles. Available in a wide range of healthcare colors, Ultem HU 1004 also exhibits negligible color drift under these test conditions.
What Are Potential Applications for Ultem HU 1004 PEI?
Non-permanent devices that remain in contact with bodily tissue or fluids for more than 24 hours and up to 29 days are applications where Ultem HU 1004 is a candidate material. Examples are rigid components associated with dialysis equipment, wound and surgical drainage applications, and devices that remain in the body to enable post-operative monitoring for longer than 24 hours.
Genesis Medical Plastics Capabilities in Ultem HU 1004
Specifications –
SEMI-FINISHED SHAPES
Rod diameters – mm
- 4mm – 152.4mm
- Custom & larger diameters on request
Plate thicknesses
- 4mm – 31.75mm
- Larger thicknesses on request
- Maximum width 610mm
All semi-finished shapes are made to order, with reasonable minimums.