供应PEI - ULTEM

Lubrizol is a leader in functional polymers for the medical industry. Lubrizol’s products feature biocompatability and biostability, high tensile strength and elongation, excellent processing attributes, and customization for a variety of applications.

Carbothane® TPU is a family of aliphatic, polycarbonate-based thermoplastic polyurethanes (TPUs) that are available in a wide range of hardnesses, colors, and radiopacifiers. If your application requires flexibility, Carbothane TPU is a premier product with elevated performance properties such as resistance to bodily fluids, good oxidative and biostable properties. This TPU may be suitable for long term implantation applications. We offer a unique capability to fill Carbothane TPUs with radiopacifiers along with the ability to custom color match to your specific application needs.

PC-3575A PC-3585A PC-3895A PC-3555D PC-3572D , .

Tecoflex® aliphatic polyether-based thermoplastic polyurethanes (TPUs) are available in a variety of hardnesses, colors and radiopacifier formulations. This TPU can be manufactured using multiple processes (Extrusion, Injection Molding and Solution) and offers an inherent ultraviolet (UV) stability that resists yellowing by aging. We offer a unique capability to fill Tecoflex TPUs with radiopacifiers along with the ability to custom color match to your specific application needs.

EG-80A EG-85A EG93A EG-100A EG-60D EG-65D EG-72D.

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Pellethane® thermoplastic polyurethanes (TPUs) offer a wide range of properties for medical and healthcare products. These polymers are available as an aromatic polyether and are known for their flexibility and wide range of hardnesses. Pellethane TPUs are ideal for a variety of medical applications including tubing, catheters, and other short-term uses.

2363-55D,2363-65D,2363-75D,2363-85A,2363-90A.

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Tecothane® aromatic polyether-based thermoplastic polyurethanes (TPUs) are unique resins which exhibit solvent resistance and biostability over a wide range of hardnesses. They are a unique product line, which includes customization options such as radiopaque filled, pre-colorization, varied hardness levels and customization. We offer a unique capability to fill Tecothane TPUs with radiopacifiers along with the ability to custom color match to your specific application needs.

TT-1074A TT-1085A TT-1095A TT-1055D TT-1065D TT-1069D TT-1072D TT-1075D-M.

............................................................... Biocompathbility and biostabilaty test results Tecoflex EG-80A Tecoflex EG-60D Tecothane TT-1085A Carbothane PC-3585A Hom olysis ISO 10993-4 PASS PASS PASS PASS Systemic Injection ISO 10993-11 PASS PASS PASS PASS Intracutaneous Test ISO 10993-10 PASS PASS PASS PASS Implantation-2 week ISO 10993-6 PASS PASS PASS PASS Pyrogen ISO 10993-11 PASS PASS PASS PASS In Vitro Hemocompatibility ISO 10993-4 PASS PASS PASS PASS Physiochemical USP 24 PASS PASS PASS PASS EN ISO 10993 Biological evaluation of medical devices:

EN ISO 10993-1:

Evaluation and testing

EN ISO 10993-2:

Animal welfare requirements

EN ISO 10993-3:

Tests for genotoxicity, carcinogenicity and reproductive toxicity

EN ISO 10993-4:

Selection of tests for interactions with blood

EN ISO 10993-5:

Tests for in vitro cytotoxicity

EN ISO 10993-6:

Tests for local effects after implantation

EN ISO 10993-7:1996

Ethylene oxide sterilization residuals

EN ISO 10993-8:2001

Part 8: Selection and qualification of reference materials for biological tests

EN ISO 10993-9:1999

Framework for identification and quantification of potential degradation products

EN ISO 10993-10:

Tests for irritation and delayed-type hypersensitivity

EN ISO 10993-11:

Tests for systemic toxicity

EN ISO 10993-12:2004

Sample preparation and reference materials

EN ISO 10993-13:1999

Identification and quantification of degradation products from polymeric medical devices

EN ISO 10993-14:2001

Part 14: Identification and quantification of degradation products from ceramics

EN ISO 10993-15:2001

Identification and quantification of degradation products from metals and alloys

EN ISO 10993-16:1997

Toxicokinetic study design for degradation products and leachables

EN ISO 10993-17:2002

Establishment of allowable limits for leachable substances

EN ISO 10993-18:

Chemical characterization of materials

EN ISO 10993-20:

Part 20: Principles and methods for immunotoxicology testing of medical devices

**All type grades conform to the requirements of. USP(U.S. Pharmacopoeia ) Class

VI and ISO 10993 tests