medical device testing
Transcrição
medical device testing
IMA MATERIALFORSCHUNG UND ANWENDUNGSTECHNIK GMBH MEDICAL PRODUCT TESTING JOINT IMPLANTS IMPLANTS FOR OSTEOSYNTHESIS IMPLANT MATERIALS Strength and wear testing of all joint implants Wear testing of hip and shoulder implants Four station knee joint The IMA Materialforschung und Anwendungstechnik GmbH laboratory for medical product testing supports you with standardized test services regarding international regulations. ACCEPTED AND ACCREDITED LABORATORY FOR MEDICAL PRODUCT TESTING Our long-term professional expertise developed from our unique position in between industry and academia research. We accompany you throughout the part of technical documentation. Determining your product related strength, fatigue and tribological properties is our main business. We meet the high level technical demands of medical product approval to provide you best test services according to national and international standards. Our excellent trained engineers benefit from long-term knowledge by facing new challenges. Since 1995 we have successfully performed medical device test services on implant products. We will be pleased to furnish you with detailed information regarding technical test series for medical product approval in accordance to current normative references and guidelines. CUSTOMIZED TESTING Beyond present standards customized tests based on current scientific publications are in increasing demand. Our medical device testing engineers support you with special test methods. HIP JOINT IMPLANTS A wide range of normative test series are required to cover technical documentation. Our test equipment enables all relevant fatigue, strength and wear tests. In the case of polyethylene wear we recommend an additional analysis of wear particles (size and morphology). KNEE JOINT IMPLANTS In accordance to the wide range of knee implant designs (e.g. mobile, fixed bearing, bior uni-condylar systems) we perform necessary fatigue, strength and wear tests. For tribological test we provide a four station knee joint simulator (Stanmore KS4) related to international standards. SHOULDER JOINT IMPLANTS Shoulder joint implants having less test standards so far. For a meaningful technical documentation we developed internal test methods based to recognized scientific publications and international guidelines. Those methods cover anatomical and inverse shoulder implant systems. Especially worst case conditions like edge loading are of particular interest. NEW STANDARDS Tissue adhesives ASTM F2255 (Tissue Adhesive Lap Shear Properties) ASTM F2256 (Tissue Adhesive Peel Properties) ASTM F2258 (Tissue Adhesive Tension Properties) ASTM F2458 (Tissue Adhesive Wound Closure Strength) simulator Fractured surface of a hip stem neck section Push-out experimental set-up for a hip implant Failure analysis - based on long-term experience and comprehensive expertise we expose failure analysis, for example, of revised implants. IMPLANTS FOR OSTEOSYNTHESIS TYPICAL STANDARDS Exemplary bone screws torsion load or bone plates bending strength is in special interest for technical documentations. In the case of implant failure, metallographic analysis are recommended and could be handled at IMA Materialforschung und Anwendungstechnik GmbH as well. SPINE IMPLANTS Medical product approval, for example, requires static and fatigue tests for interconnection mechanism and tests for components of spinal skeletal fixation systems. Blocking devices are commonly tested for load induced subsidence and expulsion characteristics. MATERIALS AND MATERIAL BEARINGS Apart from design, the implant material and its suitable bearing are essential properties for long term survivorship after implantation. Screening tests and analysis on material samples, final implant products or material bearings lead to an increased in vivo reliability. Aging influence is highly discussed as key issue for implant material functionality. We offer the recommended accelerated aging according to international standards. Hip joint implants ISO 7206-2 (Articulating surface) ISO 7206-4, -6 (Endurance of stems) ISO 7206-10, -12 (Head and socket) ASTM F1875 (Fretting corrosion) ISO 14242 (Wear test) Knee joint implants ISO 7207-2 (Articulating surface) ISO 14879-1 (Endurance of tibial trays) ISO 14243 (Wear test) ASTM F1223 (Replacement constraint) IMA-PV C/31 (Fatigue femoral component) Shoulder joint implants IMA-PV C/32 (Strenght of shoulder stems) IMA-PV C/33.1 (Wear test of anatomic shoulder implants) IMA-PV C/33.3 (Edge loading) IMA-PV C/33.4 (Wear test of inverse shoulder implants) Implants for ostheosynthesis ASTM F382 (Metal bone plates) ASTM F384 (Metal angled fixation devices) ASTM F543 (Metal bone screws) ASTM F1264 (Intramedullary fixation devices) Spine implants ASTM F1717 (Spinal implant constructs) ASTM F1798 (Interconnecting mechanisms) ASTM F2193 (Components) ASTM F2077 (Cages) ASTM F2267 (Subsidence test) IMA-PV C/40 (Expulsion test) Materials/-bearings ISO 5832-1 to -9, -11/-12, -14 (Metals) ISO 6474-1, -2 (Ceramics) ISO 5834-1 (Polyethylene) ISO 17853 (Particle analysis, polymere and metal) ASTM F1877 (Particle analysis) ASTM F2003 (Artificial aging) ASTM F1978 (Taber Abraser) IMA-PV C/36 (Cylinder on plate test) IMA-PV C/29 (Ball on plate test) IMA MATERIALFORSCHUNG UND ANWENDUNGSTECHNIK GMBH QUALITY MANAGEMENT Our laboratory for medical device testing is DAkkS (German Accreditation Body) accredited according to DIN EN ISO/IEC 17025 and recognized by ZLG (Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices) by registration number ZLG-AP-235.10.68. CONTACT Dr. rer. nat. Uta Kremling Head of Medical Product Testing P: +49 (0)351 8837-2259 F: +49 (0)351 8837-530 E: [email protected] Dipl.-Ing. Marcel Langner Laboratory Manager Medical Product Testing T: +49 (0)351 8837-2273 F: +49 (0)351 8837-530 E: [email protected] IMA Materialforschung und Anwendungstechnik GmbH Wilhelmine-Reichard-Ring 4, D-01109 Dresden P: +49 (0)351 8837-0 I F: +49 (0)351 8837-6312 I E: [email protected] www.ima-dresden.de