EndoLab - Implant Testing Services Implant Testing

Scope of certification

Certificate
Scope


Scope of accreditation EndoLab® Mechanical Engineering GmbH
Ahornweg 8 |83083 Riedering, 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


DIN 50134:2008-10
Prüfung von metallischen Werkstoffen - Druckversuch an metallischen zellularen Werkstoffen
DIN EN 455-2:2015-07
Medical gloves for single use - Part 2: Requirements and testing for physical properties
DIN EN ISO 643:2013-05
Stahl - Mikrophotographische Bestimmung der erkennbaren Korngröße (ISO 643:2012)
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
DIN EN ISO 5832-3:2017-03
Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO 5832-3:2016)
DIN EN ISO 6872:2015-11
Zahnheilkunde - Keramische Werkstoffe (ISO 6872:2015)
DIN EN ISO 6892-1:2017-02
Metallische Werkstoffe - Zugversuch - Teil 1: Prüfverfahren bei Raumtemperatur (ISO 6892-1:2016)
DIN EN ISO 7198:2017-07
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Prothesen - Tubulare vaskuläre Transplantate und Gefäßpatches (ISO 7198:2016)
DIN EN ISO 10328:2016-12
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen und Prüfverfahren (ISO 10328:2016)
DIN EN ISO 10555-1:2013-11
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555‑1:2013)
DIN EN ISO 10555-3:2013-11
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 3: Zentrale venöse Katheter (ISO 10555‑3:2013)
DIN EN ISO 10555-4:2013-11
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter (ISO 10555‑4:2013)
DIN EN ISO 10555-5:2013-11
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 5: Periphere Katheter mit innen liegender Kanüle (ISO 10555-5:2013)
DIN EN ISO 11070:2015-03
Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO 11070:2014)
DIN EN ISO 11608-1:2015-04
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 1: Kanülenbasierte Injektionssysteme (ISO 11608-1:2014)
DIN EN ISO 11608-2:2012-12
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 2: Kanülen (ISO 11608-2:2012)
DIN EN ISO 11608-3:2013-01
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 3: Fertigbehälter (ISO 11608-3:2012)
DIN EN ISO 11608-4:2016-03
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO/DIS 11608-4:2016)
DIN EN ISO 11608-5:2013-01
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012)
DIN EN ISO 13356:2016-02
Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP) (ISO 13356:2015)
DIN EN ISO 13402:2001-02
Chirurgische und zahnärztliche Handinstrumente - Bestimmung der Beständigkeit gegenüber Sterilisation, Korrosion und Wärmebehandlung (ISO 13402:1995)
DIN ISO 13926-1:2005-10
Pen-Systeme - Teil 1: Glaszylinder für Pen-Injektoren zur medizinischen Verwendung (ISO 13926-1:2004)
DIN EN ISO 14801:2017-03
Zahnheilkunde - Implantate - Dynamische Belastungsprüfung für enossale Dentalimplantate (ISO 14801:2016)
DIN EN ISO 15912:2016-08
Zahnheilkunde - Einbettmassen und hochtemperaturbeständige Stumpfmaterialien (ISO 15912:2016)
DIN EN ISO 21534:2009-08
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen (ISO 21534:2007)
DIN EN ISO 21535:2017-04
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007 + Amd 1:2016)
DIN EN ISO 21536:2014-07
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2007 + Amd.1:2014)
DIN EN ISO 22675:2016-12
Prothetik - Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten - Anforderungen und Prüfverfahren (ISO 22675:2016)
DIN EN ISO 25539-1:2017-09
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2017)
DIN EN ISO 25539-2:2013-05
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2012)
DIN EN ISO 80369-20:2015-09
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)
ISO 643:2012
Steels - Micrographic determination of the apparent grain size
ISO 4967:2013
Steel - Determination of content of non-metallic inclusions - Micrographic method using standard diagrams
ISO 5832-3:2016
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
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 6475:1989
Implants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical requirements and test methods
ISO 6872:2015
Dentistry - Ceramic materials
ISO 6892-1:2016
Metallic materials - Tensile testing - Part 1: Method of test at room temperature
ISO 7198:2016
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
ISO 7206-1:2008
Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions
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 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 7206-12:2016
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
ISO 7206-13:2016
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation 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 10328:2016
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 11491:2017
Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
ISO 11608-1:2014
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 11608-4:2016
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 13402:1995
Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure
ISO/TS 13498:2011
Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems
ISO 13779-4:2002
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
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 14242-2:2016
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 14243-2:2016
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 14705:2016
Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for hardness of monolithic ceramics at room temperature
ISO 14801:2016
Dentistry - Implants - Dynamic loading test for endosseous dental implants
ISO 14879-1:2000
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
ISO 15142-1:2003
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
ISO 15142-2:2003
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
ISO 15142-3:2003
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter measurements
ISO 15676:2016
Cardiovascular implants and artificial organs — Requirements for single- use tubing packs for cardiopulmonary by pass and extracorporeal membrane oxygenation (ECMO)
ISO 15912:2016
Dentistry - Refractory investment and die material
ISO 16402:2008
Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics
ISO 16429:2004
Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
ISO 17853:2011
Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
ISO/TR 18130:2016
Dentistry - Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants
ISO 18192-1:2011
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
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
ISO 18192-3:2017
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
ISO 18754:2013
Fine ceramics (advanced ceramics, advanced technical ceramics) - Determination of density and apparent porosity
ISO 19213:2017
Implants for surgery - Test methods of material for use as a cortical bone model
ISO 20160:2006
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
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 21535:2007/Amd 1:2016
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
ISO 21536:2007
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-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
Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for cyclic bending fatigue of monolithic ceramics at room temperature
ISO 22675:2016
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
ISO 25539-2:2012
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
ISO 80369-20: 2015
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ANSI/AAMI NS 28 : 1988/I 2006
Intracranial pressure monitoring devices
ASTM D618 - 13
Standard Practice for Conditioning Plastics for Testing
ASTM D638 - 14
Standard Test Method for Tensile Properties of Plastics
ASTM D732 - 17
Standard Test Method for Shear Strength of Plastics by Punch Tool
ASTM D792 - 13
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ASTM D882 - 12
Standard Test Method for Tensile Properties of Thin Plastic Sheeting
ASTM D2990 - 17
Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
ASTM E112 - 13
Standard Test Methods for Determining Average Grain Size
ASTM E252 - 06(2013)
Standard Test Method for Thickness of Foil, Thin Sheet, and Film by Mass Measurement
ASTM F136 - 13
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
ASTM F366 - 17
Standard Specification for Fixation Pins and Wires
ASTM F382 - 17
Standard Specification and Test Method for Metallic Bone Plates
ASTM F384 - 17
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
ASTM F451 - 16
Standard Specification for Acrylic Bone Cement
ASTM F543 - 17
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 - 17
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 - 17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
ASTM F746 - 04(2014)
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
ASTM F897 - 02(2013)
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
ASTM F1044 - 05(2017)
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
ASTM F1089 - 18
Standard Test Method for Corrosion of Surgical Instruments
ASTM F1147 - 05(2017)
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1160 - 14(2017)
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 - 16e
Standard Specification and Test Methods for Intramedullary Fixation Devices
ASTM F1357 - 14
Standard Specification for Articulating Total Wrist Implants
ASTM F1378 - 17
Standard Specification for Shoulder Prostheses
ASTM F1541 - 17
Standard Specification and Test Methods for External Skeletal Fixation Devices
ASTM F1582 - 98(2016)
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 - 17
Standard Specification for Ureteral Stents
ASTM F1829 - 17
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
ASTM F1839 - 08(2016)
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 - 16
Standard Practice for Characterization of Particles
ASTM F1926/F1926M - 14
Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
ASTM F1978 - 18
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 - 17
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 - 15
Standard Specification for Femoral Prostheses - Metallic Implants
ASTM F2077 - 17
Test method for intervertebral body fusion devices
ASTM F2079 - 09(2017)
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
ASTM F2081 - 06(2017)
Standard Guide for Characterization and Presentation ft he 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 - 17b
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F2180 - 17
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 - 18
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(2017)
Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System
ASTM F2423 - 11(2016)
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 - 17
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(2016)
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 - 16
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
ASTM F2706 - 17
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 - 16
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 - 17
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 F3018 - 17
Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
ASTM F3036 - 13
Standard Guide for Testing Absorbable Stents
ASTM F3044 - 14
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 F3140 - 17
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
ASTM F3141 - 17a
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 F3211 - 17
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
ASTM G102 - 89(2015)e
Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements
PI-3: 2017-01
Luxationsversuch 2 (LUX2)
PI-11 : 2014-11
Druckversuch statisch/dynamisch Pfanneninserts
PI-14 : 2015-12
Druckversuch statisch/dynamisch Hüftgelenkkugeln
PI-17 : 2017-02
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-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 : 2016-04
Total hip joint prostheses - 3D Frictional torque
PI-65: 2016-02
Determination of Total Ankle Replacement Contact Pressure
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-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-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-82: 2017-03
Determination of Screw Compression Force
PI-83: 2017-10
(WK33006) Standard Guide for Impingement Testing of Total Disc Prostheses
PI-84: 2018-04
(WK59162) Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components