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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
04.08.2010Prüfkapazität für Dauerschwingversuche erweitert.
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 |
| ASTM F 1044 - 05 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
| ASTM F 1089 - 02 | Standard Test Method for Corrosion of Surgical Instruments |
| ASTM F 1147 - 05 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| ASTM F 1160 - 05 | 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 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1264 - 03 | Standard Specification and Test Methods for Intramedullary Fixation Devices |
| ASTM F 1357 - 99 | Standard Specification for Articulating Total Wrist Implants |
| ASTM F 1378 - 05 | Standard Specification for Shoulder Prostheses |
| ASTM F 1541 - 02 | Standard Specification and Test Methods for External Skeletal Fixation Devices |
| ASTM F 1582 - 98 | Standard Terminology Relating to Spinal Implants |
| ASTM F 1612 - 95 | Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion |
| ASTM F 1659 - 95 | Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates |
| ASTM F 1672 - 95 | Standard Specification for Resurfacing Patellar Prosthesis |
| ASTM F 1691 - 96 | Standard test method for determining axial pull-out strength of medical bone screws |
| ASTM F 1714 - 96 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices |
| ASTM F 1715 - 00 | Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices |
| ASTM F 1717 - 04 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| ASTM F 1781 - 03 | Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| ASTM F 1798 - 97 | Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| ASTM F 1800 - 07 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1814 - 97 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1820 - 97 | Standard test method for determining the axial disassembly force of a modular acetabular device. |
| ASTM F 1828 - 97 | Standard Specification for Ureteral Stents |
| ASTM F 1829 - 98 | Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear |
| ASTM F 1839 - 01 | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| ASTM F 1854 - 01 | Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
| ASTM F 1875 - 98 | Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface |
| ASTM F 1877 - 05 | Standard Practice for Characterization of Particles |
| ASTM F 2003 - 02 | Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene |
| ASTM F 2009 - 00 | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| ASTM F 2025 - 06 | Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment |
| ASTM F 2028 - 08 | Standard Test Methods for the Dynamic Evaluation of Glenoid Loosening or Disassociation |
| ASTM F 2033 - 05 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| ASTM F 2068 - 03 | Standard Specification for Femoral Prostheses - Metallic Implants |
| ASTM F 2077 - 03 | Test methods for intervertebral body fusion devices. |
| ASTM F 2079 - 02 | Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| ASTM F 2081 - 06 | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| ASTM F 2083 - 08 | Standard Specification for Total Knee Prosthesis |
| ASTM F 2091 - 01 | Standard Specification for Acetabular Prostheses |
| ASTM F 2118 - 03 | Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials |
| ASTM F 2129 - 06 | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| ASTM F 2180 - 02 | Standard Specification for Metallic Implantable Strands and Cables |
| ASTM F 2183 - 02 | Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants. |
| ASTM F 2193 - 02 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| ASTM F 2267 - 04 | Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| ASTM F 2345 - 04 | Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
| ASTM F 2346 - 05 | Standard Test Methods for Static and Dynamic Characterization of Spinal artificial Discs. |
| ASTM F 2394 - 04 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| ASTM F 2423 - 06 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| ASTM F 2477 - 07 | Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents |
| ASTM F 2502 - 05 | Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants. |
| ASTM F 2528 - 06 | Standard Test Methods for Enteral Feeding Devices with a Retention Balloon. |
| ASTM F 2580 - 07 | Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| ASTM F 2582 - 08 | Standard Test Method for Impingement of Acetabular Prostheses |
| ASTM F 2624 - 08 | Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-discal Spinal Motion Preserving Implants |
| ASTM F 2694 - 07 | Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses |
| ASTM F 2706 - 08 | Standard Test Methods forv Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. |
| ASTM F 2722 - 08 | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate rotational Stops |
| ASTM F 2723 - 08 | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
| ASTM F 2724 - 08 | Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
| ASTM F 382 - 99 | Standard Specification and Test Method for Metallic Bone Plates |
| ASTM F 383 - 89 | Standard practice for static bending and torsion testing of intramedullary rods. |
| ASTM F 384 - 06 | Standard specifications and test methods for metallic angled orthopedic fracture fixation devices |
| ASTM F 451 - 03 | Standard specification for acrylic bone cement |
| ASTM F 543 - 07 | Standard Specification and Test Methods for Metallic Medical Bone Screws |
| ASTM F 564 - 02 | Standard Specification and Test Methods for Metallic Bone Staples |
| ASTM F 601 - 03 | Standard practice for fluorescent penetrant inspection of metallic surgical implants. |
| ASTM F 732 - 00 | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| ASTM F 897 - 02 | Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| Ceramtec: PA 02 10 0409-01 D | Prüfanweisung: Mechanische Prüfungen von keramischen Biploarschalen (DUOLOX) |
| DIN EN 12006-3 | Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 3: Endovaskuläre Implantate |
| E DIN EN 14299:2002-01 | Nichtaktive chirurgische Implantate. Besondere Anforderungen an Herz- und Gefäßimplantate. Spezielle Anforderungen an Arterienstents |
| EN 14299: 2004-08 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents |
| EN ISO 11608-1: 2000-12 | Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000) |
| EN ISO 11608-2: 2000-12 | Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000) |
| EN ISO 11608-3: 2000-12 | Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods (ISO 11608-3:2000) |
| ISO 12189: 2008-04 | 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 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: 2000-10 | Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement |
| ISO 14243 - 1: 2002-03 | 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: 2000-10 | 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 3: Loading and displacement parameters for wear testing machines with displacement control and corresponding environmental conditions for test |
| ISO 14801:2007-11 | Dentistry -- Fatigue test for endosseous dental implants |
| ISO 14879 - 1: 2000-05 | 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 17853: 2003-03 | Method for the isolation, characterization and quantification of polymer and metal wear debris. |
| ISO 18192-1: 2008-01 | Implants for surgery - Wear of total intervertebral disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test |
| ISO 25539 - 1: 2003-03 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| ISO 25539 - 2: 2008-08 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
| ISO 6474: 1994-02 | Implants for surgery - Ceramic materials based on high purity alumina |
| ISO 7206 - 1: 2008-04 | Implants for surgery - Partial and total hip joint prostheses - Part 1: 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 modular femoral heads |
| ISO 7206 - 2: 1996-05 | IImplants for surgery - Partial and total hip joint prostheses: Articulating surfaces made of metallic, ceramic and plastic materials |
| ISO 7206 - 4: 2002-10 | Implants for surgery - Partial and total hip joint prostheses - Part4: Determination of endurance properties of stemmed femoral components |
| ISO 7206 - 6: 1992-03 | Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of the head and neck region of stemmed femoral components |
| ISO 7206 - 8: 1995-04 | Implants for surgery - Partial and total hip joint prostheses - Part 8: Endurance performance of stemmed femoral components with application of torsion |
| ISO 7206 - 9: 1994-12 | Implants for surgery - Partial and total hip joint prostheses - Part 9: Determination of resistance to torque of head fixation of stemmed femoral components |
| ISO 7207 - 1: 2007-01 | 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 TR 9325: 1989-06 | Implants for surgery - Partial and total hip joints prostheses - Recommendations for simulators for evaluation of hip joint prostheses. |
| ISO TR 9326: 1989-06 | Implants for surgery - Partial and total hip joints prostheses - Guidance for laboratory evaluation of change of form bearing surfaces. |
| PI-02 | Determination of Hip Luxation with Stem Cup Contact |
| PI-03 | Determination of Hip Luxation without Stem Cup Contact |
| PI-06 | Insert Torque Test |
| PI-11 | Insert Compression Test static/dynamic |
| PI-12 | Shear Strength Push-out Test |
| PI-14 | Compression Test Hip Ball static/dynamic |
| PI-17 | Determination of Total Knee Implant Contact Pressure |
| PI-18 | Stent Radial Force Test |
| PI-19 | Fatigue Test Gliding Nail |
| PI-25 | Fatigue of Occipital-cervical Spinal Constructs |
| PI-27 | PI-27 Pen-injectors: Maximum Dose Setting (60 I.U. stop torque) |
| PI-28 | PI-28 Pen-injectors: End Of Cartridge Setting (300 I.U. stop torque) |
| PI-29 | PI-29 Pen-injectors: Exposure to Fluids and Solvents |
| PI-30 | PI-30 Pen-injectors: Dose accuracy, different dose pattern |
| PI-31 | PI-31 Pen-injectors: Drop Test Resistance with Increased Demands |
| PI-32 | PI-32 Pen-injectors: Pen Injector Cap Removal Force Test |
| PI-33 | PI-33 Pen-injectors: Needle Cover Interference Test |
| PI-34 | PI-34 Pen-injectors: Needle Compatibility |
| PI-35 | PI-35 Pen-injectors: Dispense Force Test |
| PI-36 | PI 36 Pen-injectors: Dialling torque to set a dose |
| PI-37 | PI-37 Pen-injectors: Dial Stop Torque (0 I.U.) |
| PI-38 | PI-38 Pen-injectors: Dose number character height/Dose Window Distortion |
| PI-39 | PI-39 Pen-injectors: Dose accuracy after dial stop break torque |
| PI-40 | PI-40 Pen-injectors: Disassembly Force Test |
| PI-41 | PI-41 Pen-injectors: Dust Ingress |
| PI-42 | PI-42 Ankle Implant.doc |
| PI-43 | PI-43 Determination of total knee replacement constraint |
| PI-44 | PI-44 Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses |
| PI-45 | PI-45 Impingement of Acetabular Prostheses |
| PI-46 | PI-46 Knee Endurance |
| PI-47 | PI-47 Mobile Bearing Knee Dislocation |
| PI-48 | PI-48 Stent Bending |
| PI-49 | PI-49 Tibial Knee Disassociation |
| PI-50 | PI-50 Tibial Knee Rotation Stop |
| PI-51 | PI-51 Acute Coating Durability |
| PI-52 | PI-52 Expulsion Test Spinal Implants |