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der EndoLab® Mechanical Engineering GmbH
Seb.-Tiefenthaler Str. 13 | 83101 Thansau / Rosenheim
als Prüflaboratorium für Medizinprodukte nach Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 und ISO 17025 : 1990-05 DAR-Reg.-Nr.: ZLG-P-944.98.07
Aktuelles
20.01.2012EndoLab auf der AAOS 2012
07.12.2011
Stellenausschreibung Prüfingenieur
EndoLab®
Mechanical Engineering GmbH
Seb.-Tiefenthaler Str. 13D-83101 Thansau / Rosenheim
Telefon
+49 (0)8031 - 23 13 23 0
Fax
+49 (0)8031 - 23 13 23 800
mail@endolab.de
Internet
www.endolab.de
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Anfahrtsbeschreibung
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Zertifizierungsbereich
Regelwerk Prüfverfahren |
Prüfungsart Prüfung |
| ANSI/AAMI NS 28:1988/(R)2006 | Intracranial pressure monitoring devices |
| ASTM D 638 – 10 : 2010 | Standard Test Method for Tensile Properties of Plastics |
| ASTM F 1044 – 05 : 2005 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
| ASTM F 1089 – 10 : 2010 | Standard Test Method for Corrosion of Surgical Instruments |
| ASTM F 1147 – 05 : 2005 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| ASTM F 1160 – 05 : 2005 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 1223 – 08 : 2002 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1264 – 03 : 2007e2 | Standard Specification and Test Methods for Intramedullary Fixation Devices |
| ASTM F 1357 – 09 : 2009 | Standard Specification for Articulating Total Wrist Implants |
| ASTM F 1378 – 05 : 2005 | Standard Specification for Shoulder Prostheses |
| ASTM F 1541 – 02 : 2007e1 | Standard Specification and Test Methods for External Skeletal Fixation Devices |
| ASTM F 1582 – 98 : 2003 | Standard Terminology Relating to Spinal Implants |
| ASTM F 1612 – 95 : 2005 | Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion |
| ASTM F 1672 – 95 : 2005 | Standard Specification for Resurfacing Patellar Prosthesis |
| ASTM F 1691-96 : 1996 | Standard test method for determining axial pull-out strength of medical bone screws |
| ASTM F 1714 – 96 : 2008 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices |
| ASTM F 1715 – 2000 | Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices |
| ASTM F 1717 –10 : 2010 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| ASTM F 1781 – 03 : 2009 | Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| ASTM F 1798 – 97 : 2008 | Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| ASTM F 1800 – 07 : 2007 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1814 – 97a : 2009 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1820 – 97 : 2009 | Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device |
| ASTM F 1828 – 97 : 2006 | Standard Specification for Ureteral Stents |
| ASTM F 1829 – 98 : 2009 | Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear |
| ASTM F 1839 – 08 : 2008e1 | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| ASTM F 1854 – 09 : 2009 | Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
| ASTM F 1875 – 98 : 2009 | Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface |
| ASTM F 1877 – 05 : 2010 | Standard Practice for Characterization of Particles |
| ASTM F 1978 – 00 : 2007e2 | Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
| ASTM F 2003 – 02 : 2008 | Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene |
| ASTM F 2009 – 00 : 2005 | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| ASTM F 2025 – 06 : 2006 | Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment |
| ASTM F 2028 – 08 : 2008 | Standard Test Methods for the Dynamic Evaluation of Glenoid Loosening or Disassociation |
| ASTM F 2033 – 05 : 2005 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| ASTM F 2068 – 09 | Standard Specification for Femoral Prostheses—Metallic Implants |
| ASTM F 2077 – 03 : 2003 | Test method for intervertebral body fusion devices |
| ASTM F 2079 – 09 : 2009 | Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| ASTM F 2081 – 06 : 2006 | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| ASTM F 2083 – 10 : 2010 | Standard Specification for Total Knee Prosthesis |
| ASTM F 2091 – 06 : 2006 | Standard Specification for Acetabular Prostheses |
| ASTM F 2118 – 03 : 2009 | Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials |
| ASTM F 2129 – 08 : 2008 | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| ASTM F 2180 – 02 : 2007e2 | Standard Specification for Metallic Implantable Strands and Cables |
| ASTM F 2183 – 02 : 2008 | Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants |
| ASTM F 2193 – 02 : 2002 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| ASTM F 2267 – 04 : 2004 | Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| ASTM F 2345 – 03 : 2008 | Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
| ASTM F 2346 – 05 : 2005 | Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
| ASTM F 2394 – 04 : 2004 | Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System |
| ASTM F 2423 – 05 : 2006 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| ASTM F 2477 – 07 : 2007 | Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents |
| ASTM F 2502 – 05 : 2009 | Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants |
| ASTM F 2580 – 09 : 2009 | Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| ASTM F 2582 – 08 : 2008 | Standard Test Method for Impingement of Acetabular Prostheses |
| ASTM F 2624 – 07 : 2008 | Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants |
| ASTM F 2694 – 07 : 2007 | Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses |
| ASTM F 2722 – 08 : 2008 | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| ASTM F 2723 – 08 : 2008 | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
| ASTM F 2724 – 08 : 2008 | Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
| ASTM F 2777 – 10 : 2010 | Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion |
| ASTM F 2789 – 10 : 2010 | Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| ASTM F 2790 – 10 : 2010 | Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses |
| ASTM F 382 – 99 : 2008e1 | Standard Specification and Test Method for Metallic Bone Plates |
| ASTM F 384 – 06 : 2004 | Standard specifications and test methods for metallic angled orthopedic fracture fixation devices |
| ASTM F 451 – 08 : 2008 | Standard Specification for acrylic bone cement |
| ASTM F 543 – 07 : 2007e1 | Standard Specification and Test Methods for Metallic Medical Bone Screws |
| ASTM F 564 – 10 : 2010 | Standard Specification and Test Methods for Metallic Bone Staples |
| ASTM F 601 – 03 : 2008 | Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| ASTM F 732 – 00 : 2006 | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| ASTM F 897 – 02 : 2007-10 | Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| ASTM F2528 – 06 : 2006-06 | Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
| DIN EN 12006-3 : 2009-08 | Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Blutgefäßstents und Hohlvenenfilter |
| DIN EN ISO 11608-1 : 2001-05 | Pen-Injektoren zur medizinischen Anwendung - Teil 1: Pen-Injektoren; Anforderungen und Prüfverfahren |
| DIN EN ISO 11608-2 : 2000-02 | Pen-Injektoren zur medizinischen Anwendung - Teil 2: Kanülen- Anforderungen und Prüfverfahren |
| DIN EN ISO 11608-3 : 2000-03 | Pen-Injektoren zur medizinischen Anwendung - Teil 3: Fertigkarpulen - Anforderungen und Prüfverfahren |
| DIN EN ISO 25539-1 : 2009-08 | Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005); Deutsche Fassung EN ISO 25539-1:2009 |
| DIN EN ISO 25539-2 : 2009-08 | Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008); Deutsche Fassung EN ISO 25539-2:2009 |
| DIN EN ISO 6872 : 2009-01 | Zahnheilkunde - Keramische Werkstoffe (ISO 6872:2008); Deutsche Fassung EN ISO 6872:2008 |
| DIN ISO 13926-1 | Pen-Systeme - Teil 1: Glaszylinder für Pen-Injektoren zur medizinischen Verwendung (ISO 13926-1:2004) |
| ISO 12189 : 2008-05 | Implants for surgery -- Mechanical testing of implantable spinal devices -- Fatigue test method for spinal implant assemblies using an anterior support |
| ISO 13356 : 2008-06 | Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
| ISO 13923-1 | Pen systems - Part 1: Glass cylinders for pen-injectors for medical use |
| ISO 14242-1 : 2002-03 | Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests |
| ISO 14242-2 : 2000-09 | Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement |
| ISO 14243-1 : 2009-11 | Implants for surgery – Wear of total knee joint prostheses – Part 1: Loading and displacement parameters for wear testing machines with load control and corresponding environmental conditions for tests |
| ISO 14243-2 : 2009-11 | Implants for surgery – Wear of total knee joint prostheses – Part 2: Methods of measurement |
| ISO 14243-3 : 2004-09 | Implants for surgery – Wear of total knee joint prostheses – Part 1: Loading and displacement parameters for wear testing machines with displacement control and corresponding environmental conditions for test |
| ISO 14801 : 2008-02 | Dental implants - Dynamic continuous fatigue test |
| ISO 14879-1 : 2000-06 | Implants for surgery - Total knee joint prostheses Part 1: Determination of endurance properties of knee tibial trays |
| ISO 15142-1 : 2003-08 | Implants for surgery — Metal intramedullary nailing systems — Part 1: Intramedullary nails |
| ISO 15142-2 : 2003-08 | Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
| ISO 15142-3 : 2003-08 | Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter measurements |
| ISO 16402 : 2008-05 | Implants for surgery -- Acrylic resin cement -- Flexural fatigue testing of acrylic resin cements used in orthopaedics |
| ISO 18192-1 : 2008-1 | Implants for surgery -- Wear of total intervertebral spinal disc prostheses -- Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test |
| ISO 18192-2 : 2010-06 | Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
| ISO 18754 : 2003-08 | Fine ceramics (advanced ceramics, advanced technical ceramics) - Determination of density and apparent porosity |
| ISO 22214 : 2006-02 | Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for cyclic bending fatigue of monolithic ceramics at room temperature |
| ISO 5834-3 : 2005-07 | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
| ISO 7206-1 : 2008-04 | Implants for surgery - Partial and total hip joint prostheses: Classification and designation of dimensions |
| ISO 7206-10 : 2003-12 | Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads |
| ISO 7206-2 : 1996-06 | Implants for surgery - Partial and total hip joint prostheses: Articulating surfaces made of metallic, ceramic and plastic materials |
| ISO 7206-4 : 2010-06 | Implants for surgery - Partial and total hip joint prostheses: Determination of endurance properties of stemmed femoral components |
| ISO 7206-6 : 1992-03 | Determination of endurance properties of head and neck region of stemmed femoral components |
| ISO 7206-8 : 1995-04 | Endurance performance of stemmed femoral components with application of torsion |
| ISO 7206-9 : 1994-12 | Determination of resistance to torque of head fixation of stemmed femoral components |
| ISO 7207-1 : 2007-02 | Implants for surgery - Components for partial and total knee-joint prostheses - Part 1: Classification, definitions and designation of dimensions |
| ISO 7207-2 : 1998-07 | Implants for surgery – Components for partial and total knee-joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
| ISO 9585 : 1990-12 | Implants for surgery; Determination of bending strength and stiffness of bone plates |
| PA-1 : 1998-02 | Ring-on-Disc (nach ISO 6474) |
| PI-11 : 2005-06 | Druckversuch statisch/dynamisch Pfanneninserts |
| PI-12 : 1998-02 | Scherfestigkeit im push-out Versuch |
| PI-14 : 2003-08 | Druckversuch statisch/dynamisch Hüftgelenkkugeln |
| PI-17 : 2008-07 | Druckverteilung von Knieendoprothesen |
| PI-18 : 2008-07 | Stent Kollabierversuch |
| PI-19 : 2010-02 | Dauerschwingversuch Gleitnagel |
| PI-25 : 2008-04 | Fatigue occipital-cervical spinal constructs |
| PI-27 : 2006-11 | Pen Injector 60 IU Stop |
| PI-28 : 2006-10 | Pen Injector 300 IU Stop |
| PI-29 : 2006-11 | Pen Injector Fluid Solvent Exposure |
| PI-3 : 2007-04 | Bestimmung des Luxationsverhaltens ohne Schaft-Pfanne Kontakt |
| PI-30 : 2006-11 | Pen Injector Dose accuracy different dose pattern |
| PI-31 : 2006-11 | Pen Injector Drop Test Resistance with Increased Demands |
| PI-32 : 2006-11 | Pen Injector Cap Removal Force Test |
| PI-33 : 2006-11 | Pen Injector Needle Cover Interference |
| PI-34 : 2006-11 | Pen Injector Needle Compatibility |
| PI-35 : 2006-11 | Pen Injector Dispense Force Test |
| PI-36 : 2006-11 | Pen Injector Dialing torque to set a dose |
| PI-37 : 2006-11 | Pen Injector Dial Stop Torque _0 I.U. |
| PI-38 : 2006-11 | Pen Injector Dose number character height_Dose Window Distortion |
| PI-39 : 2006-11 | Pen Injector Dose accuracy after dial stop break torque |
| PI-40 : 2006-11 | Pen Injector Disassembly Force Test |
| PI-41 : 2006-11 | Pen Injector Dust Ingress |
| PI-42 : 2008-04 | Ankle Implant |
| PI-44 : 2008-04 | Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses ASTM F 2694 |
| PI-45 : 2008-04 | Impingement of Acetabular Prostheses ASTM F 2582 |
| PI-47 : 2008-04 | Mobile Bearing Knee Dislocation ASTM F 2724 |
| PI-48 : 2008-04 | Stent Bending |
| PI-49 : 2008-04 | Tibial Knee Disassociation ASTM F 2723 |
| PI-50 : 2008-04 | Tibial Knee Rotation Stop ASTM F 2722 |
| PI-51 : 2008-04 | Acute Coating Durability |
| PI-52 : 2008-06 | Expulsion test – spinal implants |
| PI-53 : 2009-01 | Fatigue testing of stemmed femoral TKA components |
| PI-54 : 2009-07 | Mechanical Test – VBR spinal implants |
| PI-6 : 2010-06 | Insert Torsionsversuch |