EndoLab - Implant Testing Services Implant Testing

Scope of certification

Certificate
Scope


Scope of accreditation EndoLab® Mechanical Engineering GmbH
Seb.-Tiefenthaler Str. 13 | 83101 Thansau / Rosenheim, Germany


as a test laboratory for medical devices according to guideline 93/42/EWG of the Council from June 14th 1993 and DIN EN ISO/IEC 17025:2005 D-PL-18838-02-00


ANSI/AAMI NS 28: 1988/I 2006
Intracranial pressure monitoring devices
ASTM D638 - 14
Standard Test Method for Tensile Properties of Plastics
ASTM E112 - 13
Standard Test Methods for Determining Average Grain Size
ASTM F136 - 13
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
ASTM F382 - 14
Standard Specification and Test Method for Metallic Bone Plates
ASTM F384 - 12
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
ASTM F451 - 08
Standard Specification for acrylic bone cement
ASTM F543 - 13e
Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F561 - 13
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ASTM F564 - 10 (2015)
Standard Specification and Test Methods for Metallic Bone Staples
ASTM F601 - 13
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
ASTM F648 - 14
Ultra-High-Molecular-Weight Polyethylene Powder and Standard Specification for Fabricated Form for Surgical Implants
ASTM F732 - 00 (2011)
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
ASTM F897 - 02 (2013)
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
ASTM F1044 - 05 (2011)e
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
ASTM F1089 - 10
Standard Test Method for Corrosion of Surgical Instruments
ASTM F1147 - 05 (2011)
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1160 - 14
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
ASTM F1223 - 14
Standard Test Method for Determination of Total Knee Replacement Constraint
ASTM F1264 - 16
Standard Specification and Test Methods for Intramedullary Fixation Devices
ASTM F1357 - 14
Standard Specification for Articulating Total Wrist Implants
ASTM F1378 - 12
Standard Specification for Shoulder Prostheses
ASTM F1541 - 02(2015)
Standard Specification and Test Methods for External Skeletal Fixation Devices
ASTM F1582 - 98(2011)
Standard Terminology Relating to Spinal Implants
ASTM F1672 - 14
Standard Specification for Resurfacing Patellar Prosthesis
ASTM F1714 - 96(2013)
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
ASTM F1717 - 15
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F1781 - 15
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
ASTM F1798 - 13
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F1800 - 12
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F1814 - 15
Standard Guide for Evaluating Modular Hip and Knee Joint Components
ASTM F1820 - 13
Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
ASTM F1828 - 97(2014)
Standard Specification for Urereal Stents
ASTM F1829 - 98(2009)
Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
ASTM F1839 - 08(2012)e
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
ASTM F1854 - 15
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
ASTM F1875 - 98(2014)
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
ASTM F1877 - 05(2010)
Standard Practice for Characterization of Particles
ASTM F1926 - 14
Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
ASTM F1978 - 12
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
ASTM F2003 - 02(2015)
Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene
ASTM F2009 - 00(2011)
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
ASTM F2025 - 06(2012)
Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
ASTM F2028 - 14
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
ASTM F2033 - 12
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
ASTM F2068 - 09
Standard Specification for Femoral Prostheses—Metallic Implants
ASTM F2077 - 14
Test method for intervertebral body fusion devices
ASTM F2079 - 09(2013)
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
ASTM F2081 - 06(2013)
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
ASTM F2083 - 12
Standard Specification for Total Knee Prosthesis
ASTM F2091 - 15
Standard Specification for Acetabular Prostheses
ASTM F2118 - 14
Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
ASTM F2129 - 15
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F2180 - 02(2015)
Standard Specification for Metallic Implantable Strands and Cables
ASTM F2183 - 02(2008)
Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
ASTM F2193 - 14
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F2267 - 04(2011)
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F2345 - 03(2013)
Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
ASTM F2346 - 05 (2011)
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
ASTM F2394 - 07(2013)
Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System
ASTM F2423 - 11
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
ASTM F2477 - 07(2013)
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
ASTM F2502 - 11
Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
ASTM F2514 - 08 (2014)
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
ASTM F2516 - 14
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
ASTM F2528 - 06(2014)
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
ASTM F2580 - 13
Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
ASTM F2582 - 14
Standard Test Method for Impingement of Acetabular Prostheses
ASTM F2606 - 08(2014)
Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
ASTM F2624 - 12
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
ASTM F2665 - 09(2014)
Standard Specification for Total Ankle Replacement Prosthesis
ASTM F2694 - 07(2013)
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
ASTM F2706 - 08(2014)
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
ASTM F2722 - 15
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
ASTM F2723 - 13a
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
ASTM F2724 - 08(2014)
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
ASTM F2743 - 11
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
ASTM F2777 - 10
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
ASTM F2789 - 10(2015)
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ASTM F2790 - 10(2014)
Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
ASTM F2791 - 15
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
ASTM F2887 - 12
Standard Specification for Total Elbow Prostheses
ASTM F2942 - 13
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
ASTM F2952 - 14
Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
ASTM F2979 - 14
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
ASTM F2996 - 13
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
ASTM F3014 - 14
Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
ASTM F3036 - 13
Standard Guide for Testing Absorbable Stents
ASTM F3044 - 14
Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
ASTM F3047M - 15
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
ASTM F3067 - 14
Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
ASTM F3087 - 15
Standard Specification for Acrylic Molding Resin for Medical Implant Applications
ASTM F3141 - 15
Standard Guide for Total Knee Replacement Loading Profiles
ASTM F3161 - 16
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
ASTM F3172 - 15
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
ASTM G102 - 89 (2015)e
Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements
DIN 50134: 2008-10
Prüfung von metallischen Werkstoffen - Druckversuch an metallischen zellularen Werkstoffen
DIN EN 843-2: 2007-03
Hochleistungskeramik - Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur - Teil 2: Bestimmung des Elastizitätsmoduls, Schubmoduls und der Poissonzahl
DIN EN 843-4: 2005-08
Hochleistungskeramik - Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur - Teil 4: Härteprüfung nach Vickers, Knoop und Rockwell
ISO 5833: 2002
Implants for surgery - Acrylic resin cements
ISO 5834-3: 2005
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
ISO 5838-1: 2013
Implants for surgery - Skeletal pins and wires - Part 1: Material and mechanical requirements
ISO 5838-2: 1991
Implants for surgery - Skeletal pins and wires - Part 2: Steinmann skeletal pins - Dimensions
ISO 5838-3: 1993
Implants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires
ISO 6474-1: 2010
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
ISO 6474-2: 2012
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
ISO 6872: 2008
Dentistry - Ceramic materials
ISO/DIS 6892-1: 2014
Metallic materials - Tensile testing - Part 1: Method of test at room temperature
ISO 7198: 1998
Cardiovascular implants - Tubular vascular prostheses
ISO 7206-1: 2008
Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions
ISO 7206-10: 2003
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
ISO 7206-2: 2011
Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 7206-4: 2010
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
ISO 7206-6: 2013
Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ISO 7207-1: 2007
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
ISO 7207-2: 2011
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
ISO 9585: 1990
Implants for surgery; determination of bending strength and stiffness of bone plates
ISO 10328: 2006
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
ISO 10555-1: 2013
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
ISO 10555-3: 2013
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
ISO 10555-4: 2013
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
ISO 10555-5: 2013
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
ISO 11070: 2014
Sterile single-use intravascular introducers, dilators and guidewires
ISO 11608-1: 2015
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
ISO 11608-2: 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
ISO 11608-3: 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
ISO 11608-4: 2006
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
ISO 11608-5: 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
ISO 12189: 2008
Implants for surgery -- Mechanical testing of implantable spinal devices -- Fatigue test method for spinal implant assemblies using an anterior support
ISO 13356: 2015
Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
ISO/TS 13498: 2011
Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems
ISO 13926-1: 2004
Pen systems - Part 1: Glass cylinders for pen-injectors for medical use
ISO 14242-1: 2014
Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242-2: 2000
Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurement
ISO 14243-1: 2009
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 test
ISO 14243-2: 2009
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
ISO 14243-3: 2014
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 14705: 2008
Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for hardness of monolithic ceramics at room temperature
ISO 14801: 2007
Dentistry - Implants - Dynamic loading test for endosseous dental implants
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 15912: 2016
Dentistry - Refractory investment and die material
ISO 16402: 2008-05
Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics
ISO 17853: 2011-03
Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
ISO 18192-1: 2011-03
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: 2013-03
Fine ceramics (advanced ceramics, advanced technical ceramics) - Determination of density and apparent porosity
ISO 21534: 2007
Non-active surgical implants - Joint replacement implants - Particular requirements
ISO 21535: 2007
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
ISO 21536: 2007 + Amd.1: 2014
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
ISO 22214: 2006-02
Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for cyclic bending fatigue of monolithic ceramics at room temperature
ISO/DIS 25539-1: 2015
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
ISO 25539-2: 2012
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
PI-3: 2007-04
Bestimmung des Luxationsverhaltens ohne Schaft-Pfanne Kontakt
PI-11: 2014-11
Druckversuch statisch/dynamisch Pfanneninserts
PI-12: 1998-02
Scherfestigkeit im push-out Versuch
PI-14: 2015-12
Druckversuch statisch/dynamisch Hüftgelenkkugeln
PI-17: 2014-11
Druckverteilung von Knieendoprothesen
PI-19: 2010-02
Dauerschwingversuch Gleitnagel
PI-27 : 2014-11
Pen Injector 60 IU Stop
PI-28: 2014-11
Pen Injector 300 IU Stop
PI-29: 2014-11
Pen Injector Fluid Solvent Exposure
PI-30: 2014-11
Pen Injector Dose accuracy different dose pattern
PI-31: 2014-11
Pen Injector Drop Test Resistance with Increased Demands
PI-32: 2014-11
Pen Injector Cap Removal Force Test
PI-33: 2014-11
Pen Injector Needle Cover Interference
PI-35: 2014-11
Pen Injector Dispense Force Test
PI-36: 2014-11
Pen Injector Dialing torque to set a dose
PI-37: 2014-11
Pen Injector Dial Stop Torque 0 I.U.
PI-38: 2014-11
Pen Injector Dose number character height Dose Window Distortion
PI-39: 2014-11
Pen Injector Dose accuracy after dial stop break torque
PI-40: 2014-11
Pen Injector Disassembly Force Test
PI-41: 2014-11
Pen Injector Dust Ingress
PI-52: 2015-10
Expulsion test - spinal implants
PI-53: 2010-11
Fatigue testing of stemmed femoral TKA components
PI-54: 2010-11
Mechanical Test - VBR spinal implants
PI-55: 2010-12
Femoral condyle - fatigue test
PI-57: 2013-10
DIN EN 12006-3: 2009-08 - Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Blutgefäßstents und Hohlvenenfilter
PI-58 :2013-10
ISO 7206-8 - Endurance performance of stemmed femoral components with application of torsion
PI-59: 2013-10
ISO 7206-9 - Determination of resistance to torque of head fixation of stemmed femoral components
PI-60: 2014-10
ISO 6474 (1994): Implants for surgery - Ceramic materials based on high purity alumina
PI-61: 2014-10
Reverse Shoulder System Wear Test
PI-62: 2014-10
Anatomic Shoulder System Wear Test
PI-63: 2014-10
Total Ankle Replacement System Wear Test
PI-64: 2014-11
Total hip joint prostheses - 3D Frictional torque
PI-65: 2016-02
Determination of Total Ankle Replacement Contact Pressure
PI-67: 2016-02
(WK45235) Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
PI-68: 2016-02
(WK52025) Standard Test Method for Metallic Bone Plates Used in Small Bone Fracture Fixation
PI-69: 2016-02
(WK28883) Standard Test Method for Environmental Fatigue Testing of Acetabular Devices for Total Hip Replacement
PI-70: 2016-02
(WK28214) Practice for Accelerated Fretting Corrosion Testing of Modular Head and Neck Taper Junctions Used in Total Hip Replacement
PI-71: 2016-02
(WK34814) Standard Guide for Collection and Evaluation of Metallic Products from Environmental Tests
PI-72: 2016-02
(WK24686) Standard Guide for Assessment of Hard-on-Hard Total Hip Replacement Devices of Acetabular Devices for Total Hip Replacement
PI-73: 2016-02
(WK51649) Standard Test Method for Fatigue Testing of Total Knee Femoral Components under Closing Conditions
PI-76: 2016-02
(WK45142) Standard Practice for Mechanical Characterization of Spinous Process Plates
PI-77: 2016-02
(ISO 11492.2) Implants for surgery - Test method for impact resistance of ceramic femoral heads for hip joint prostheses
PI-78: 2016-02
(ISO 14242-4) Implants for surgery - wear of total hip-joint prostheses - Part 4: Testing total hip joint prostheses under variations in surgical positioning
PI-79: 2016-07
(ISO 14243-5) Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint - Loading and displacement parameters for testing machines and corresponding environmental conditions for test
PI-80: 2016-02
(ISO 7206-12) Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular components
PI-81: 2016-02
(ISO 7206-13) Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components