{"id":5423,"date":"2024-10-21T17:29:40","date_gmt":"2024-10-21T15:29:40","guid":{"rendered":"https:\/\/endolab.org\/?page_id=5423"},"modified":"2026-01-26T14:38:54","modified_gmt":"2026-01-26T13:38:54","slug":"scope-of-certification","status":"publish","type":"page","link":"https:\/\/endolab.org\/de\/scope-of-certification\/","title":{"rendered":"Scope of certification"},"content":{"rendered":"
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Scope of certification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Test laboratory for medical devices according to ISO 17025<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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View our Certificate and Scope<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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ASME V&V40<\/a> – 2018<\/b><\/p>

Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices<\/b><\/b><\/p><\/td>

Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices<\/td><\/tr>

ANSI\/AAMI NS 28 1988\/I 2006<\/b><\/a><\/p>

Intracranial pressure monitoring devices<\/b><\/b><\/p><\/td>

Intracranial pressure monitoring devices<\/td><\/tr>

ASTM C1499<\/a> – 19<\/b><\/p>

Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at Ambient Temperature<\/b><\/b><\/p><\/td>

Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at Ambient Temperature<\/td><\/tr>

ASTM D2990 – 17<\/b><\/p>

Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics<\/b><\/b><\/p><\/td>

Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics<\/td><\/tr>

ASTM D570 – 22<\/b><\/p>

Standard Test Method for Water Absorption of Plastics<\/b><\/b><\/p><\/td>

Standard Test Method for Water Absorption of Plastics<\/td><\/tr>

ASTM D618<\/a> – 21<\/b><\/p>

Standard Practice for Conditioning Plastics for Testing<\/b><\/b><\/p><\/td>

Standard Practice for Conditioning Plastics for Testing<\/td><\/tr>

ASTM D638<\/a> – 22<\/b><\/p>

Standard Test Method for Tensile Properties of Plastics<\/b><\/b><\/p><\/td>

Standard Test Method for Tensile Properties of Plastics<\/td><\/tr>

ASTM D732<\/a> – 17<\/b><\/p>

Standard Test Method for Shear Strength of Plastics by Punch Tool<\/b><\/b><\/p><\/td>

Standard Test Method for Shear Strength of Plastics by Punch Tool<\/td><\/tr>

ASTM D790 – 17<\/b><\/p>

Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials<\/b><\/b><\/p><\/td>

Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials<\/td><\/tr>

ASTM D792<\/a> – 20<\/b><\/p>

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement<\/b><\/b><\/p><\/td>

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement<\/td><\/tr>

ASTM D882<\/a> – 18<\/b><\/p>

Standard Test Method for Tensile Properties of Thin Plastic Sheeting<\/b><\/b><\/p><\/td>

Standard Test Method for Tensile Properties of Thin Plastic Sheeting<\/td><\/tr>

ASTM E112<\/a> – 13(2021)<\/b><\/p>

Standard Test Methods for Determining Average Grain Size<\/b><\/b><\/p><\/td>

Standard Test Methods for Determining Average Grain Size<\/td><\/tr>

ASTM E1920 – 03 (Reapproved 2021)<\/b><\/p>

Standard Guide for Metallographic Preparation of Thermal Sprayed Coatings<\/b><\/b><\/p><\/td>

Standard Guide for Metallographic Preparation of Thermal Sprayed Coatings<\/td><\/tr>
ASTM E883 – 11 (2024)<\/strong><\/td>Standard Guide for Re\ufb02ected\u2013Light Photomicrography<\/td><\/tr>

ASTM F1044<\/a> – 05(2017)<\/b><\/p>

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings<\/b><\/b><\/p><\/td>

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings<\/td><\/tr>

ASTM F1089<\/a> – 18<\/b><\/p>

Standard Test Method for Corrosion of Surgical Instruments<\/b><\/b><\/p><\/td>

Standard Test Method for Corrosion of Surgical Instruments<\/td><\/tr>

ASTM F1147<\/a> – 24<\/b><\/p>

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings<\/b><\/b><\/p><\/td>

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings<\/td><\/tr>

ASTM F1160<\/a> – 14(2017)<\/b><\/p>

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate\/Metallic Coatings<\/b><\/b><\/p><\/td>

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate\/Metallic Coatings<\/td><\/tr>

ASTM F1223<\/a> – 20<\/b><\/p>

Standard Test Method for Determination of Total Knee Replacement Constraint<\/b><\/b><\/p><\/td>

Standard Test Method for Determination of Total Knee Replacement Constraint<\/td><\/tr>

ASTM F1264<\/a> – 16e<\/b><\/p>

Standard Specification and Test Methods for Intramedullary Fixation Devices<\/b><\/b><\/p><\/td>

Standard Specification and Test Methods for Intramedullary Fixation Devices<\/td><\/tr>

ASTM F1357<\/a> – 23<\/b><\/p>

Standard Specification for Articulating Total Wrist Implants<\/b><\/b><\/p><\/td>

Standard Specification for Articulating Total Wrist Implants<\/td><\/tr>

ASTM F136<\/a> – 13(2021)e1<\/b><\/p>

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)<\/b><\/b><\/p><\/td>

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)<\/td><\/tr>

ASTM F1378<\/a> – 18e1<\/b><\/p>

Standard Specification for Shoulder Prostheses<\/b><\/b><\/p><\/td>

Standard Specification for Shoulder Prostheses<\/td><\/tr>

ASTM F1541<\/a> – 17<\/b><\/p>

Standard Specification and Test Methods for External Skeletal Fixation Devices<\/b><\/b><\/p><\/td>

Standard Specification and Test Methods for External Skeletal Fixation Devices<\/td><\/tr>

ASTM F1582 – 98(2016)<\/b><\/p>

Standard Terminology Relating to Spinal Implants<\/b><\/b><\/p><\/td>

Standard Terminology Relating to Spinal Implants<\/td><\/tr>

ASTM F1609<\/a> – 23<\/b><\/p>

Standard Specification for Calcium Phosphate Coatings for Implantable Materials<\/b><\/b><\/p><\/td>

Standard Specification for Calcium Phosphate Coatings for Implantable Materials<\/td><\/tr>

ASTM F1635 – 16<\/b><\/p>

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants<\/b><\/b><\/p><\/td>

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants<\/td><\/tr>

ASTM F1672<\/a> – 14(2019)<\/b><\/p>

Standard Specification for Resurfacing Patellar Prosthesis<\/b><\/b><\/p><\/td>

Standard Specification for Resurfacing Patellar Prosthesis<\/td><\/tr>

ASTM F1714 – 96(2018)<\/b><\/p>

Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices<\/b><\/b><\/p><\/td>

Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices<\/td><\/tr>

ASTM F1717<\/a> – 21<\/b><\/p>

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model<\/b><\/b><\/p><\/td>

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model<\/td><\/tr>

ASTM F1781<\/a> – 21<\/b><\/p>

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants<\/b><\/b><\/p><\/td>

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants<\/td><\/tr>

ASTM F1798<\/a> – 21<\/b><\/p>

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants<\/b><\/b><\/p><\/td>

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants<\/td><\/tr>

ASTM F1800<\/a> – 19e<\/b><\/p>

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements<\/b><\/b><\/p><\/td>

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements<\/td><\/tr>

ASTM F1801<\/a> – 20<\/b><\/p>

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials<\/b><\/b><\/p><\/td>

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials<\/td><\/tr>

ASTM F1814<\/a> – 22<\/b><\/p>

Standard Guide for Evaluating Modular Hip and Knee Joint Components<\/b><\/b><\/p><\/td>

Standard Guide for Evaluating Modular Hip and Knee Joint Components<\/td><\/tr>

ASTM F1820<\/a> – 22<\/b><\/p>

Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device<\/b><\/b><\/p><\/td>

Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device<\/td><\/tr>

ASTM F1829<\/a> – 23<\/b><\/p>

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear<\/b><\/b><\/p><\/td>

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear<\/td><\/tr>

ASTM F1839<\/a> – 08(2021)<\/b><\/p>

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments<\/b><\/b><\/p><\/td>

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments<\/td><\/tr>

ASTM F1854<\/a> – 15<\/b><\/p>

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants<\/b><\/b><\/p><\/td>

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants<\/td><\/tr>

ASTM F1875<\/a> – 98(2022)<\/b><\/p>

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface<\/b><\/b><\/p><\/td>

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface<\/td><\/tr>

ASTM F1877<\/a> – 16<\/b><\/p>

Standard Practice for Characterization of Particles<\/b><\/b><\/p><\/td>

Standard Practice for Characterization of Particles<\/td><\/tr>

ASTM F1926\/F1926M<\/a> – 14(2021)<\/b><\/p>

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings<\/b><\/b><\/p><\/td>

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings<\/td><\/tr>

ASTM F1978<\/a> – 22<\/b><\/p>

Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser<\/b><\/b><\/p><\/td>

Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser<\/td><\/tr>

ASTM F1980<\/a> – 21<\/b><\/p>

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices<\/b><\/b><\/p><\/td>

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices<\/td><\/tr>

ASTM F2003<\/a> – 02(2022)<\/b><\/p>

Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene<\/b><\/b><\/p><\/td>

Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene<\/td><\/tr>

ASTM F2009<\/a> – 20<\/b><\/p>

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses<\/b><\/b><\/p><\/td>

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses<\/td><\/tr>

ASTM F2025<\/a> – 06(2018)<\/b><\/p>

Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment<\/b><\/b><\/p><\/td>

Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment<\/td><\/tr>

ASTM F2028<\/a> – 17<\/b><\/p>

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation<\/b><\/b><\/p><\/td>

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation<\/td><\/tr>

ASTM F2033<\/a> – 20<\/b><\/p>

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials<\/b><\/b><\/p><\/td>

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials<\/td><\/tr>

ASTM F2051 – 00 (Reapproved 2022)<\/b><\/p>

Standard Speci\ufb01cation for Implantable Saline Filled Breast Prosthesis – Part 9.2.2 (Shell Leakage Testing)<\/b><\/b><\/p><\/td>

Standard Speci\ufb01cation for Implantable Saline Filled Breast Prosthesis – Part 9.2.2 (Shell Leakage Testing)<\/td><\/tr>

ASTM F2051 – 00 (Reapproved 2022)<\/b><\/p>

Standard Speci\ufb01cation for Implantable Saline Filled Breast Prosthesis – Part 9.2.3 (Shell)<\/b><\/b><\/p><\/td>

Standard Speci\ufb01cation for Implantable Saline Filled Breast Prosthesis – Part 9.2.3 (Shell)<\/td><\/tr>

ASTM F2051 – 00 (Reapproved 2022)<\/b><\/p>

Standard Speci\ufb01cation for Implantable Saline Filled Breast Prosthesis – Part 9.5 (Abrasion Testing)<\/b><\/b><\/p><\/td>

Standard Speci\ufb01cation for Implantable Saline Filled Breast Prosthesis – Part 9.5 (Abrasion Testing)<\/td><\/tr>

ASTM F2068<\/a> – 15<\/b><\/p>

Standard Specification for Femoral Prostheses – Metallic Implants<\/b><\/b><\/p><\/td>

Standard Specification for Femoral Prostheses – Metallic Implants<\/td><\/tr>

ASTM F2077<\/a> – 22<\/b><\/p>

Test method for intervertebral body fusion devices<\/b><\/b><\/p><\/td>

Test method for intervertebral body fusion devices<\/td><\/tr>

ASTM F2079<\/a> – 09(2022)<\/b><\/p>

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents<\/b><\/b><\/p><\/td>

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents<\/td><\/tr>

ASTM F2081<\/a> – 06(2022)<\/b><\/p>

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents<\/b><\/b><\/p><\/td>

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents<\/td><\/tr>

ASTM F2083<\/a> – 21<\/b><\/p>

Standard Specification for Total Knee Prosthesis<\/b><\/b><\/p><\/td>

Standard Specification for Total Knee Prosthesis<\/td><\/tr>

ASTM F2091<\/a> – 15<\/b><\/p>

Standard Specification for Acetabular Prostheses<\/b><\/b><\/p><\/td>

Standard Specification for Acetabular Prostheses<\/td><\/tr>

ASTM F2118<\/a> – 14(2020)<\/b><\/p>

Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials<\/b><\/b><\/p><\/td>

Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials<\/td><\/tr>

ASTM F2129<\/a> – 19a<\/b><\/p>

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices<\/b><\/b><\/p><\/td>

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices<\/td><\/tr>

ASTM F2180<\/a> – 17<\/b><\/p>

Standard Specification for Metallic Implantable Strands and Cables<\/b><\/b><\/p><\/td>

Standard Specification for Metallic Implantable Strands and Cables<\/td><\/tr>

ASTM F2193<\/a> – 20<\/b><\/p>

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System<\/b><\/b><\/p><\/td>

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System<\/td><\/tr>

ASTM F2217\/F2217M \u2013 13(2023)<\/b><\/p>

Standard Practice for Coating\/Adhesive Weight Determination<\/b><\/b><\/p><\/td>

Standard Practice for Coating\/Adhesive Weight Determination<\/td><\/tr>

ASTM F2267<\/a> – 24<\/b><\/p>

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression<\/b><\/b><\/p><\/td>

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression<\/td><\/tr>

ASTM F2345<\/a> – 21<\/b><\/p>

Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads<\/b><\/b><\/p><\/td>

Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads<\/td><\/tr>

ASTM F2346<\/a> – 18<\/b><\/p>

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs<\/b><\/b><\/p><\/td>

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs<\/td><\/tr>

ASTM F2394<\/a> – 07(2022)<\/b><\/p>

Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System<\/b><\/b><\/p><\/td>

Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System<\/td><\/tr>

ASTM F2423<\/a> – 11(2020)<\/b><\/p>

Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses<\/b><\/b><\/p><\/td>

Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses<\/td><\/tr>

ASTM F2477<\/a> – 23<\/b><\/p>

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents<\/b><\/b><\/p><\/td>

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents<\/td><\/tr>

ASTM F2502<\/a> – 17<\/b><\/p>

Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants<\/b><\/b><\/p><\/td>

Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants<\/td><\/tr>

ASTM F2514 – 21<\/b><\/p>

Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading<\/b><\/b><\/p><\/td>

Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading<\/td><\/tr>

ASTM F2516<\/a> – 22<\/b><\/p>

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials<\/b><\/b><\/p><\/td>

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials<\/td><\/tr>

ASTM F2528<\/a> – 06(2023)<\/b><\/p>

Standard Test Methods for Enteral Feeding Devices with a Retention Balloon<\/b><\/b><\/p><\/td>

Standard Test Methods for Enteral Feeding Devices with a Retention Balloon<\/td><\/tr>

ASTM F2580<\/a> – 18<\/b><\/p>

Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis<\/b><\/b><\/p><\/td>

Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis<\/td><\/tr>

ASTM F2582<\/a> – 20<\/b><\/p>

Standard Test Method for Impingement of Acetabular Prostheses<\/b><\/b><\/p><\/td>

Standard Test Method for Impingement of Acetabular Prostheses<\/td><\/tr>

ASTM F2606<\/a> – 08(2021)<\/b><\/p>

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems<\/b><\/b><\/p><\/td>

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems<\/td><\/tr>

ASTM F2624<\/a> – 12(2020)<\/b><\/p>

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs<\/b><\/b><\/p><\/td>

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs<\/td><\/tr>

ASTM F2665<\/a> – 21<\/b><\/p>

Standard Specification for Total Ankle Replacement Prosthesis<\/b><\/b><\/p><\/td>

Standard Specification for Total Ankle Replacement Prosthesis<\/td><\/tr>

ASTM F2694<\/a> – 16(2020)<\/b><\/p>

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses<\/b><\/b><\/p><\/td>

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses<\/td><\/tr>

ASTM F2706<\/a> – 18<\/b><\/p>

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model<\/b><\/b><\/p><\/td>

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model<\/td><\/tr>

ASTM F2722<\/a> – 21<\/b><\/p>

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops<\/b><\/b><\/p><\/td>

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops<\/td><\/tr>

ASTM F2723<\/a> – 21<\/b><\/p>

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate\/Bearing Resistance to Dynamic Disassociation<\/b><\/b><\/p><\/td>

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate\/Bearing Resistance to Dynamic Disassociation<\/td><\/tr>

ASTM F2724<\/a> – 21<\/b><\/p>

Standard Test Method for Evaluating Mobile Bearing Knee Dislocation<\/b><\/b><\/p><\/td>

Standard Test Method for Evaluating Mobile Bearing Knee Dislocation<\/td><\/tr>

ASTM F2743<\/a> – 11(2018)<\/b><\/p>

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems<\/b><\/b><\/p><\/td>

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems<\/td><\/tr>

ASTM F2777<\/a> – 23<\/b><\/p>

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion<\/b><\/b><\/p><\/td>

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion<\/td><\/tr>

ASTM F2789<\/a> – 10(2020)<\/b><\/p>

Standard Guide for Mechanical and Functional Characterization of Nucleus Devices<\/b><\/b><\/p><\/td>

Standard Guide for Mechanical and Functional Characterization of Nucleus Devices<\/td><\/tr>

ASTM F2790<\/a> – 10(2019)e<\/b><\/p>

Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses<\/b><\/b><\/p><\/td>

Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses<\/td><\/tr>

ASTM F2791<\/a> – 24<\/b><\/p>

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions<\/b><\/b><\/p><\/td>

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions<\/td><\/tr>

ASTM F2824<\/a> – 10(2020)<\/b><\/p>

Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids<\/b><\/b><\/p><\/td>

Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids<\/td><\/tr>

ASTM F2887<\/a> – 23<\/b><\/p>

Standard Specification for Total Elbow Prostheses<\/b><\/b><\/p><\/td>

Standard Specification for Total Elbow Prostheses<\/td><\/tr>

ASTM F2902 – 16e<\/b><\/p>

Standard Guide for Assessment of Absorbable Polymeric<\/b><\/b><\/p><\/td>

Standard Guide for Assessment of Absorbable Polymeric<\/td><\/tr>

ASTM F2942<\/a> – 19<\/b><\/p>

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents<\/b><\/b><\/p><\/td>

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents<\/td><\/tr>

ASTM F2952<\/a> – 14<\/b><\/p>

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold<\/b><\/b><\/p><\/td>

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold<\/td><\/tr>

ASTM F2979<\/a> – 20<\/b><\/p>

Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses<\/b><\/b><\/p><\/td>

Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses<\/td><\/tr>

ASTM F2996<\/a> – 20<\/b><\/p>

Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems<\/b><\/b><\/p><\/td>

Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems<\/td><\/tr>

ASTM F3014<\/a> – 14<\/b><\/p>

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures<\/b><\/b><\/p><\/td>

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures<\/td><\/tr>

ASTM F3018<\/a> – 17<\/b><\/p>

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices<\/b><\/b><\/p><\/td>

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices<\/td><\/tr>

ASTM F3036 – 21<\/b><\/p>

Standard Guide for Testing Absorbable Stents<\/b><\/b><\/p><\/td>

Standard Guide for Testing Absorbable Stents<\/td><\/tr>

ASTM F3044<\/a> – 20<\/b><\/p>

Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants<\/b><\/b><\/p><\/td>

Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants<\/td><\/tr>

ASTM F3047<\/a>M – 23<\/b><\/p>

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations<\/b><\/b><\/p><\/td>

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations<\/td><\/tr>

ASTM F3067<\/a> – 14(2021)<\/b><\/p>

Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents<\/b><\/b><\/p><\/td>

Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents<\/td><\/tr>

ASTM F3087<\/a> – 15<\/b><\/p>

Standard Specification for Acrylic Molding Resin for Medical Implant Applications<\/b><\/b><\/p><\/td>

Standard Specification for Acrylic Molding Resin for Medical Implant Applications<\/td><\/tr>

ASTM F3090<\/a> – 20<\/b><\/p>

Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement<\/b><\/b><\/p><\/td>

Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement<\/td><\/tr>

ASTM F3140<\/a> – 23<\/b><\/p>

Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements<\/b><\/b><\/p><\/td>

Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements<\/td><\/tr>

ASTM F3141<\/a> – 23<\/b><\/p>

Standard Guide for Total Knee Replacement Loading Profiles<\/b><\/b><\/p><\/td>

Standard Guide for Total Knee Replacement Loading Profiles<\/td><\/tr>

ASTM F3143 – 20<\/b><\/p>

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator<\/b><\/b><\/p><\/td>

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator<\/td><\/tr>

ASTM F3161<\/a> – 16<\/b><\/p>

Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions<\/b><\/b><\/p><\/td>

Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions<\/td><\/tr>

ASTM F3172 – 15(2021)<\/b><\/p>

Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices<\/b><\/b><\/p><\/td>

Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices<\/td><\/tr>

ASTM F3210<\/a> – 22e1<\/b><\/p>

Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions<\/b><\/b><\/p><\/td>

Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions<\/td><\/tr>

ASTM F3211 – 17<\/b><\/p>

Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices<\/b><\/b><\/p><\/td>

Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices<\/td><\/tr>

ASTM F3295<\/a> – 18<\/b><\/p>

Standard Guide for Impingement Testing of Total Disc Prostheses<\/b><\/b><\/p><\/td>

Standard Guide for Impingement Testing of Total Disc Prostheses<\/td><\/tr>
ASTM F3306 – 19 Standard Test Method for Ion Release Evaluation of Medical Implants<\/b><\/b><\/td>Standard Test Method for Ion Release Evaluation of Medical Implants<\/td><\/tr>

ASTM F3334<\/a> – 19<\/b><\/p>

Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components<\/b><\/b><\/p><\/td>

Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components<\/td><\/tr>

ASTM F3335 – 20<\/b><\/p>

Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion<\/b><\/b><\/p><\/td>

Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion<\/td><\/tr>

ASTM F3446 – 20<\/b><\/p>

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator<\/b><\/b><\/p><\/td>

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator<\/td><\/tr>

ASTM F3495 – 23<\/b><\/p>

Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components<\/b><\/b><\/p><\/td>

Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components<\/td><\/tr>

ASTM F3505<\/a> – 21<\/b><\/p>

Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance<\/b><\/b><\/p><\/td>

Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance<\/td><\/tr>

ASTM F3574<\/a> – 22<\/b><\/p>

Standard Test Methods for Sacroiliac Joint Fusion Devices<\/b><\/b><\/p><\/td>

Standard Test Methods for Sacroiliac Joint Fusion Devices<\/td><\/tr>

ASTM F366<\/a> – 24<\/b><\/p>

Standard Specification for Fixation Pins and Wires<\/b><\/b><\/p><\/td>

Standard Specification for Fixation Pins and Wires<\/td><\/tr>
ASTM F3631 – 24 Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices<\/b><\/b><\/td>Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices<\/td><\/tr>

ASTM F382<\/a> – 17<\/b><\/p>

Standard Specification and Test Method for Metallic Bone Plates<\/b><\/b><\/p><\/td>

Standard Specification and Test Method for Metallic Bone Plates<\/td><\/tr>

ASTM F384<\/a> – 17<\/b><\/p>

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices<\/b><\/b><\/p><\/td>

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices<\/td><\/tr>

ASTM F451<\/a> – 21<\/b><\/p>

Standard Specification for Acrylic Bone Cement<\/b><\/b><\/p><\/td>

Standard Specification for Acrylic Bone Cement<\/td><\/tr>

ASTM F543<\/a> – 23<\/b><\/p>

Standard Specification and Test Methods for Metallic Medical Bone Screws<\/b><\/b><\/p><\/td>

Standard Specification and Test Methods for Metallic Medical Bone Screws<\/td><\/tr>

ASTM F561<\/a> – 19<\/b><\/p>

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids<\/b><\/b><\/p><\/td>

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids<\/td><\/tr>

ASTM F564<\/a> – 17<\/b><\/p>

Standard Specification and Test Methods for Metallic Bone Staples<\/b><\/b><\/p><\/td>

Standard Specification and Test Methods for Metallic Bone Staples<\/td><\/tr>

ASTM F648<\/a> – 21<\/b><\/p>

Ultra-High-Molecular-Weight Polyethylene Powder and Standard Specification for Fabricated Form for Surgical Implants<\/b><\/b><\/p><\/td>

Ultra-High-Molecular-Weight Polyethylene Powder and Standard Specification for Fabricated Form for Surgical Implants<\/td><\/tr>

ASTM F703 – 18(2022)<\/b><\/p>

Standard Specification for Implantable Breast Prostheses – Part 10.2 (Gel Penetration Test Method)<\/b><\/b><\/p><\/td>

Standard Specification for Implantable Breast Prostheses – Part 10.2 (Gel Penetration Test Method)<\/td><\/tr>

ASTM F703 – 18(2022)<\/b><\/p>

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.3 (Silicone Gel Test Method)<\/b><\/b><\/p><\/td>

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.3 (Silicone Gel Test Method)<\/td><\/tr>

ASTM F703 – 18(2022)<\/b><\/p>

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.4 (Gel Cohesion)<\/b><\/b><\/p><\/td>

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.4 (Gel Cohesion)<\/td><\/tr>

ASTM F703 – 18(2022)<\/b><\/p>

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.5 (Gel Bleed Test Method)<\/b><\/b><\/p><\/td>

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.5 (Gel Bleed Test Method)<\/td><\/tr>

ASTM F732 – 17<\/b><\/p>

Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses<\/b><\/b><\/p><\/td>

Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses<\/td><\/tr>

ASTM F746 – 04(2021)<\/b><\/p>

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials<\/b><\/b><\/p><\/td>

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials<\/td><\/tr>

ASTM F897<\/a> – 19<\/b><\/p>

Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws<\/b><\/b><\/p><\/td>

Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws<\/td><\/tr>

ASTM G102<\/a> – 23<\/b><\/p>

Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements<\/b><\/b><\/p><\/td>

Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements<\/td><\/tr>

DIN 50113:2018<\/b><\/p>

Pr\u00fcfung metallischer Werkstoffe\u00a0– Umlaufbiegeversuch<\/b><\/b><\/p><\/td>

Pr\u00fcfung metallischer Werkstoffe\u00a0– Umlaufbiegeversuch<\/td><\/tr>

DIN 50134<\/a>:2024-07<\/b><\/p>

Pr\u00fcfung von metallischen Werkstoffen – Druckversuch an metallischen zellularen Werkstoffen<\/b><\/b><\/p><\/td>

Pr\u00fcfung von metallischen Werkstoffen – Druckversuch an metallischen zellularen Werkstoffen<\/td><\/tr>

DIN EN 455-2<\/a>:2024-07<\/b><\/p>

Medical gloves for single use – Part 2: Requirements and testing for physical properties<\/b><\/b><\/p><\/td>

Medical gloves for single use – Part 2: Requirements and testing for physical properties<\/td><\/tr>

DIN EN 843<\/a>-2:2007-03<\/b><\/p>

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil 2: Bestimmung des Elastizit\u00e4tsmoduls, Schubmoduls und der Poissonzahl<\/b><\/b><\/p><\/td>

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil 2: Bestimmung des Elastizit\u00e4tsmoduls, Schubmoduls und der Poissonzahl<\/td><\/tr>

DIN EN 843<\/a>-4:2005-08<\/b><\/p>

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil\u00a04: H\u00e4rtepr\u00fcfung nach Vickers, Knoop und Rockwell<\/b><\/b><\/p><\/td>

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil\u00a04: H\u00e4rtepr\u00fcfung nach Vickers, Knoop und Rockwell<\/td><\/tr>

DIN EN ISO 10328<\/a>:2016-12<\/b><\/p>

Prothetik\u00a0– Pr\u00fcfung der Struktur von Prothesen der unteren Gliedma\u00dfen\u00a0– Anforderungen und Pr\u00fcfverfahren (ISO\u00a010328:2016)<\/b><\/b><\/p><\/td>

Prothetik\u00a0– Pr\u00fcfung der Struktur von Prothesen der unteren Gliedma\u00dfen\u00a0– Anforderungen und Pr\u00fcfverfahren (ISO\u00a010328:2016)<\/td><\/tr>

DIN EN ISO 10555<\/a>-1:2024-03<\/b><\/p>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013 + Amd 1:2017)<\/b><\/b><\/p><\/td>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013 + Amd 1:2017)<\/td><\/tr>

DIN EN ISO 10555-3<\/a>:2013-11<\/b><\/p>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 3: Zentrale ven\u00f6se Katheter (ISO\u00a010555-3:2013)<\/b><\/b><\/p><\/td>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 3: Zentrale ven\u00f6se Katheter (ISO\u00a010555-3:2013)<\/td><\/tr>

DIN EN ISO 10555-4<\/a>:2024-03<\/b><\/p>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 4: Ballondilatationskatheter (ISO\u00a010555-4:2013)<\/b><\/b><\/p><\/td>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 4: Ballondilatationskatheter (ISO\u00a010555-4:2013)<\/td><\/tr>

DIN EN ISO 10555-5<\/a>:2013-11<\/b><\/p>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 5: Periphere Katheter mit innen liegender Kan\u00fcle (ISO 10555-5:2013)<\/b><\/b><\/p><\/td>

Intravaskul\u00e4re Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 5: Periphere Katheter mit innen liegender Kan\u00fcle (ISO 10555-5:2013)<\/td><\/tr>

DIN EN ISO 11070<\/a>:2019-04<\/b><\/p>

Einf\u00fchrinstrumente f\u00fcr intravaskul\u00e4re Katheter zur einmaligen Verwendung (ISO 11070:2014 + Amd 1:2018)<\/b><\/b><\/p><\/td>

Einf\u00fchrinstrumente f\u00fcr intravaskul\u00e4re Katheter zur einmaligen Verwendung (ISO 11070:2014 + Amd 1:2018)<\/td><\/tr>

DIN EN ISO 11607<\/a>-1:2024-02<\/b><\/p>

Verpackungen f\u00fcr in der Endverpackung zu sterilisierende Medizinprodukte\u00a0– Teil\u00a01: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme<\/b><\/b><\/p><\/td>

Verpackungen f\u00fcr in der Endverpackung zu sterilisierende Medizinprodukte\u00a0– Teil\u00a01: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme<\/td><\/tr>

DIN EN ISO 11608<\/a>-1:2022-09<\/b><\/p>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Pr\u00fcfverfahren – Teil 1: Kan\u00fclenbasierte Injektionssysteme (ISO 11608-1:2022)<\/b><\/b><\/p><\/td>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Pr\u00fcfverfahren – Teil 1: Kan\u00fclenbasierte Injektionssysteme (ISO 11608-1:2022)<\/td><\/tr>

DIN EN ISO 11608-2<\/a>:2022-09<\/b><\/p>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Pr\u00fcfverfahren – Teil 2: Kan\u00fclen (ISO 11608-2:2022)<\/b><\/b><\/p><\/td>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Pr\u00fcfverfahren – Teil 2: Kan\u00fclen (ISO 11608-2:2022)<\/td><\/tr>

DIN EN ISO 11608-3<\/a>:2024-01<\/b><\/p>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Pr\u00fcfverfahren – Teil 3: Fertigbeh\u00e4lter (ISO 11608-3:2022)<\/b><\/b><\/p><\/td>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Pr\u00fcfverfahren – Teil 3: Fertigbeh\u00e4lter (ISO 11608-3:2022)<\/td><\/tr>

DIN EN ISO 11608-4<\/a>:2022-09<\/b><\/p>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung\u00a0– Anforderungen und Pr\u00fcfverfahren\u00a0– Teil\u00a04: Kan\u00fclenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO\u00a011608-4:2022)<\/b><\/b><\/p><\/td>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung\u00a0– Anforderungen und Pr\u00fcfverfahren\u00a0– Teil\u00a04: Kan\u00fclenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO\u00a011608-4:2022)<\/td><\/tr>

DIN EN ISO 11608-5<\/a>:2023-05<\/b><\/p>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung\u00a0– Anforderungen und Pr\u00fcfverfahren\u00a0– Teil\u00a05: Automatisierte Funktionen (ISO\u00a011608-5:2022)<\/b><\/b><\/p><\/td>

Kan\u00fclenbasierte Injektionssysteme zur medizinischen Verwendung\u00a0– Anforderungen und Pr\u00fcfverfahren\u00a0– Teil\u00a05: Automatisierte Funktionen (ISO\u00a011608-5:2022)<\/td><\/tr>

DIN EN ISO 11953<\/a>:2010-11<\/b><\/p>

Klinisches Verhalten manuell angewandter Drehmomentschl\u00fcssel<\/b><\/b><\/p><\/td>

Klinisches Verhalten manuell angewandter Drehmomentschl\u00fcssel<\/td><\/tr>

DIN EN ISO 13356<\/a>:2016-02<\/b><\/p>

Chirurgische Implantate – Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP) (ISO\u00a013356:2015)<\/b><\/b><\/p><\/td>

Chirurgische Implantate – Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP) (ISO\u00a013356:2015)<\/td><\/tr>

DIN EN ISO 13402<\/a>:2001-02<\/b><\/p>

Chirurgische und zahn\u00e4rztliche Handinstrumente\u00a0– Bestimmung der Best\u00e4ndigkeit gegen\u00fcber Sterilisation, Korrosion und W\u00e4rmebehandlung (ISO\u00a013402:1995)<\/b><\/b><\/p><\/td>

Chirurgische und zahn\u00e4rztliche Handinstrumente\u00a0– Bestimmung der Best\u00e4ndigkeit gegen\u00fcber Sterilisation, Korrosion und W\u00e4rmebehandlung (ISO\u00a013402:1995)<\/td><\/tr>

DIN EN ISO 14607:2018<\/b><\/p>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.2.1 \/ Anhang B.1 & B.2 (Pr\u00fcfung auf Unversehrtheit der H\u00fclle)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.2.1 \/ Anhang B.1 & B.2 (Pr\u00fcfung auf Unversehrtheit der H\u00fclle)<\/td><\/tr>

DIN EN ISO 14607:2018<\/b><\/p>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.2.2.1 \/ Anhang C.1 (Erm\u00fcdungspr\u00fcfung)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.2.2.1 \/ Anhang C.1 (Erm\u00fcdungspr\u00fcfung)<\/td><\/tr>

DIN EN ISO 14607:2018<\/b><\/p>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.2.2.2 \/ Anhang C.2 (Aufprallpr\u00fcfung)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.2.2.2 \/ Anhang C.2 (Aufprallpr\u00fcfung)<\/td><\/tr>

DIN EN ISO 14607:2018<\/b><\/p>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.3.3.2 \/ Anhang E (Koh\u00e4sionspr\u00fcfung Silikongel)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.3.3.2 \/ Anhang E (Koh\u00e4sionspr\u00fcfung Silikongel)<\/td><\/tr>

DIN EN ISO 14607:2018<\/b><\/p>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.3.3.3 \/ Anhang F (Penetration von Silikongel)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate \u2013 Mammaimplantate \u2013 Besondere Anforderungen – Part 7.2.3.3.3 \/ Anhang F (Penetration von Silikongel)<\/td><\/tr>

DIN EN ISO 14801<\/a>:2017-03<\/b><\/p>

Zahnheilkunde\u00a0– Implantate\u00a0– Dynamische Belastungspr\u00fcfung f\u00fcr enossale Dentalimplantate (ISO\u00a014801:2016)<\/b><\/b><\/p><\/td>

Zahnheilkunde\u00a0– Implantate\u00a0– Dynamische Belastungspr\u00fcfung f\u00fcr enossale Dentalimplantate (ISO\u00a014801:2016)<\/td><\/tr>

DIN EN ISO 15912<\/a>:2016-08<\/b><\/p>

Zahnheilkunde – Einbettmassen und hochtemperaturbest\u00e4ndige Stumpfmaterialien (ISO 15912:2016)<\/b><\/b><\/p><\/td>

Zahnheilkunde – Einbettmassen und hochtemperaturbest\u00e4ndige Stumpfmaterialien (ISO 15912:2016)<\/td><\/tr>

DIN EN ISO 16061<\/a>:2021<\/b><\/p>

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden\u00a0– Allgemeine Anforderungen (ISO\u00a016061:2021) – 7.2 Pr\u00e4klinische Bewertung<\/b><\/b><\/p><\/td>

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden\u00a0– Allgemeine Anforderungen (ISO\u00a016061:2021) – 7.2 Pr\u00e4klinische Bewertung<\/td><\/tr>
DIN EN ISO 19023:2018 Zahnheilkunde – Kieferorthop\u00e4dische Ankerschrauben (ISO 19023:2018)<\/b><\/b><\/td>Zahnheilkunde – Kieferorthop\u00e4dische Ankerschrauben (ISO 19023:2018)<\/td><\/tr>

DIN EN ISO 21534<\/a>:2009-08<\/b><\/p>

Nichtaktive chirurgische Implantate\u00a0– Implantate zum Gelenkersatz\u00a0– Besondere Anforderungen (ISO\u00a021534:2007)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate\u00a0– Implantate zum Gelenkersatz\u00a0– Besondere Anforderungen (ISO\u00a021534:2007)<\/td><\/tr>

DIN EN ISO 21535<\/a>:2017-04<\/b><\/p>

Nichtaktive chirurgische Implantate\u00a0– Implantate zum Gelenkersatz\u00a0– Besondere Anforderungen an Implantate f\u00fcr den H\u00fcftgelenkersatz (ISO\u00a021535:2007\u00a0+ Amd\u00a01:2016)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate\u00a0– Implantate zum Gelenkersatz\u00a0– Besondere Anforderungen an Implantate f\u00fcr den H\u00fcftgelenkersatz (ISO\u00a021535:2007\u00a0+ Amd\u00a01:2016)<\/td><\/tr>

DIN EN ISO 21536<\/a>:2014-07<\/b><\/p>

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate f\u00fcr den Kniegelenkersatz (ISO 21536:2007 + Amd.1:2014)<\/b><\/b><\/p><\/td>

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate f\u00fcr den Kniegelenkersatz (ISO 21536:2007 + Amd.1:2014)<\/td><\/tr>

DIN EN ISO 22675:2016-12<\/b><\/p>

Prothetik – Pr\u00fcfung von Kn\u00f6chel-Fu\u00df-Passteilen und Fu\u00dfeinheiten – Anforderungen und Pr\u00fcfverfahren (ISO 22675:2016)<\/b><\/b><\/p><\/td>

Prothetik – Pr\u00fcfung von Kn\u00f6chel-Fu\u00df-Passteilen und Fu\u00dfeinheiten – Anforderungen und Pr\u00fcfverfahren (ISO 22675:2016)<\/td><\/tr>

DIN EN ISO 25539<\/a>-1:2018-05<\/b><\/p>

Kardiovaskul\u00e4re Implantate\u00a0– Endovaskul\u00e4re Implantate\u00a0– Teil\u00a01: Endovaskul\u00e4re Prothesen (ISO\u00a025539-1:2017)<\/b><\/b><\/p><\/td>

Kardiovaskul\u00e4re Implantate\u00a0– Endovaskul\u00e4re Implantate\u00a0– Teil\u00a01: Endovaskul\u00e4re Prothesen (ISO\u00a025539-1:2017)<\/td><\/tr>

DIN EN ISO 25539<\/a>-2:2021<\/b><\/p>

Kardiovaskul\u00e4re Implantate – Endovaskul\u00e4re Implantate – Teil 2: Gef\u00e4\u00dfstents (ISO 25539-2:2020)<\/b><\/b><\/p><\/td>

Kardiovaskul\u00e4re Implantate – Endovaskul\u00e4re Implantate – Teil 2: Gef\u00e4\u00dfstents (ISO 25539-2:2020)<\/td><\/tr>

DIN EN ISO 29022:2013<\/b><\/p>

Zahnheilkunde \u2013 Adh\u00e4sion \u2013 Pr\u00fcfung der Abscherverbundfestigkeit mit einer ausgesparten Klinge (ISO 29022:2013)<\/b><\/b><\/p><\/td>

Zahnheilkunde \u2013 Adh\u00e4sion \u2013 Pr\u00fcfung der Abscherverbundfestigkeit mit einer ausgesparten Klinge (ISO 29022:2013)<\/td><\/tr>

DIN EN ISO 527-1:2019-12<\/b><\/p>

Bestimmung der Zugeigenschaften\u00a0– Teil\u00a01: Allgemeine Grunds\u00e4tze<\/b><\/b><\/p><\/td>

Bestimmung der Zugeigenschaften\u00a0– Teil\u00a01: Allgemeine Grunds\u00e4tze<\/td><\/tr>

DIN EN ISO 5832<\/a>-2:2018<\/b><\/p>

Chirurgische Implantate – Metallische Werkstoffe – Teil 2: Unlegiertes Titan (ISO 5832-2:2018)<\/b><\/b><\/p><\/td>

Chirurgische Implantate – Metallische Werkstoffe – Teil 2: Unlegiertes Titan (ISO 5832-2:2018)<\/td><\/tr>

DIN EN ISO 5832-3<\/a>:2022<\/b><\/p>

Chirurgische Implantate\u00a0– Metallische Werkstoffe\u00a0– Teil\u00a03: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO\u00a05832-3:2021)<\/b><\/b><\/p><\/td>

Chirurgische Implantate\u00a0– Metallische Werkstoffe\u00a0– Teil\u00a03: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO\u00a05832-3:2021)<\/td><\/tr>

DIN EN ISO 6872<\/a>:2019-01<\/b><\/p>

Zahnheilkunde\u00a0– Keramische Werkstoffe (ISO\u00a06872:2015)<\/b><\/b><\/p><\/td>

Zahnheilkunde\u00a0– Keramische Werkstoffe (ISO\u00a06872:2015)<\/td><\/tr>

DIN EN ISO 6892-1<\/a>:2020-06<\/b><\/p>

Metallische Werkstoffe\u00a0– Zugversuch\u00a0– Teil\u00a01: Pr\u00fcfverfahren bei Raumtemperatur (ISO\u00a06892-1:2016)<\/b><\/b><\/p><\/td>

Metallische Werkstoffe\u00a0– Zugversuch\u00a0– Teil\u00a01: Pr\u00fcfverfahren bei Raumtemperatur (ISO\u00a06892-1:2016)<\/td><\/tr>

DIN EN ISO 7198<\/a>:2017-07<\/b><\/p>

Kardiovaskul\u00e4re Implantate und extrakorporale Systeme – Vaskul\u00e4re Prothesen – Tubulare vaskul\u00e4re Transplantate und Gef\u00e4\u00dfpatches (ISO 7198:2016)<\/b><\/b><\/p><\/td>

Kardiovaskul\u00e4re Implantate und extrakorporale Systeme – Vaskul\u00e4re Prothesen – Tubulare vaskul\u00e4re Transplantate und Gef\u00e4\u00dfpatches (ISO 7198:2016)<\/td><\/tr>

DIN EN ISO 7864:2016-12<\/b><\/p>

Sterile Injektionskan\u00fclen f\u00fcr den Einmalgebrauch – Anforderungen und Pr\u00fcfverfahren (ISO 7864:2016)<\/b><\/b><\/p><\/td>

Sterile Injektionskan\u00fclen f\u00fcr den Einmalgebrauch – Anforderungen und Pr\u00fcfverfahren (ISO 7864:2016)<\/td><\/tr>

DIN EN ISO 80369-20<\/a>:2015-09<\/b><\/p>

Verbindungsst\u00fccke mit kleinem Durchmesser f\u00fcr Fl\u00fcssigkeiten und Gase in medizinischen Anwendungen – Teil 20: Allgemeine Pr\u00fcfverfahren (ISO 80369-20:2015)<\/b><\/b><\/p><\/td>

Verbindungsst\u00fccke mit kleinem Durchmesser f\u00fcr Fl\u00fcssigkeiten und Gase in medizinischen Anwendungen – Teil 20: Allgemeine Pr\u00fcfverfahren (ISO 80369-20:2015)<\/td><\/tr>

DIN EN ISO 9626:2016<\/b><\/p>

Kan\u00fclenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten \u2013 Anforderungen und Pr\u00fcfverfahren (ISO 9626:2016)<\/b><\/b><\/p><\/td>

Kan\u00fclenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten \u2013 Anforderungen und Pr\u00fcfverfahren (ISO 9626:2016)<\/td><\/tr>

DIN ISO 13926-1<\/a>:2020-02<\/b><\/p>

Pen-Systeme – Teil 1: Glaszylinder f\u00fcr Pen-Injektoren zur medizinischen Verwendung (ISO 13926-1:2004)<\/b><\/b><\/p><\/td>

Pen-Systeme – Teil 1: Glaszylinder f\u00fcr Pen-Injektoren zur medizinischen Verwendung (ISO 13926-1:2004)<\/td><\/tr>

DIN ISO 5832-4<\/a>:2015-12<\/b><\/p>

Chirurgische Implantate – Metallische Werkstoffe – Teil 4: Kobalt-Chrom-Molybd\u00e4n-Gusslegierung (ISO 5832-4:2014)<\/b><\/b><\/p><\/td>

Chirurgische Implantate – Metallische Werkstoffe – Teil 4: Kobalt-Chrom-Molybd\u00e4n-Gusslegierung (ISO 5832-4:2014)<\/td><\/tr>

DIN ISO 5834-2:2020<\/b><\/p>

Chirurgische Implantate \u2013 Ultrahochmolekulares Polyethylen \u2013 Teil 2: Halbzeuge (ISO 5834-2:2019)<\/b><\/b><\/p><\/td>

Chirurgische Implantate \u2013 Ultrahochmolekulares Polyethylen \u2013 Teil 2: Halbzeuge (ISO 5834-2:2019)<\/td><\/tr>

ISO 10328<\/a>:2016<\/b><\/p>

Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods<\/b><\/b><\/p><\/td>

Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods<\/td><\/tr>

ISO 10555-1:2013<\/b><\/p>

Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements<\/b><\/b><\/p><\/td>

Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements<\/td><\/tr>

ISO 10555-3<\/a>:2013<\/b><\/p>

Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters<\/b><\/b><\/p><\/td>

Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters<\/td><\/tr>

ISO 10555-4<\/a>:2013<\/b><\/p>

Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters<\/b><\/b><\/p><\/td>

Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters<\/td><\/tr>

ISO 10555-5<\/a>:2013<\/b><\/p>

Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters<\/b><\/b><\/p><\/td>

Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters<\/td><\/tr>

ISO 11070<\/a>:2014<\/b><\/p>

Sterile single-use intravascular introducers, dilators and guidewires<\/b><\/b><\/p><\/td>

Sterile single-use intravascular introducers, dilators and guidewires<\/td><\/tr>

ISO 1143:2021<\/b><\/p>

Metallic materials – Rotating bar bending fatigue testing<\/b><\/b><\/p><\/td>

Metallic materials – Rotating bar bending fatigue testing<\/td><\/tr>

ISO 11491<\/a>:2017<\/b><\/p>

Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses<\/b><\/b><\/p><\/td>

Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses<\/td><\/tr>

ISO 11608-1<\/a>:2022<\/b><\/p>

Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems<\/b><\/b><\/p><\/td>

Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems<\/td><\/tr>

ISO 11608-2<\/a>:2022<\/b><\/p>

Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles<\/b><\/b><\/p><\/td>

Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles<\/td><\/tr>

ISO 11608-3<\/a>:2022<\/b><\/p>

Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers<\/b><\/b><\/p><\/td>

Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers<\/td><\/tr>

ISO 11608-4<\/a>:2022<\/b><\/p>

Pen-injectors for medical use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors<\/b><\/b><\/p><\/td>

Pen-injectors for medical use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors<\/td><\/tr>

ISO 11608-5<\/a>:2022<\/b><\/p>

Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions<\/b><\/b><\/p><\/td>

Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions<\/td><\/tr>

ISO 12189<\/a>:2008<\/b><\/p>

Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support<\/b><\/b><\/p><\/td>

Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support<\/td><\/tr>

ISO 13175-3<\/a>:2012<\/b><\/p>

Implants for surgery – Calcium phosphates – Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes<\/b><\/b><\/p><\/td>

Implants for surgery – Calcium phosphates – Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes<\/td><\/tr>

ISO 13179<\/a>-1:2021<\/b><\/p>

Implants for surgery – Plasma-sprayed unalloyed titanium coatings on metallic surgical implants – Part 1: General requirements<\/b><\/b><\/p><\/td>

Implants for surgery – Plasma-sprayed unalloyed titanium coatings on metallic surgical implants – Part 1: General requirements<\/td><\/tr>

ISO 13314:2011<\/b><\/p>

Mechanical testing of metals \u2014 Ductility testing \u2014 Compression test for porous and cellular metals<\/b><\/b><\/p><\/td>

Mechanical testing of metals \u2014 Ductility testing \u2014 Compression test for porous and cellular metals<\/td><\/tr>

ISO 13356<\/a>:2015<\/b><\/p>

Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)<\/b><\/b><\/p><\/td>

Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)<\/td><\/tr>

ISO 13402<\/a>:1995<\/b><\/p>

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure<\/b><\/b><\/p><\/td>

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure<\/td><\/tr>

ISO 13779-2<\/a>:2018<\/b><\/p>

Implants for surgery – Hydroxyapatite – Part 2: Thermally sprayed coatings of hydroxyapatite<\/b><\/b><\/p><\/td>

Implants for surgery – Hydroxyapatite – Part 2: Thermally sprayed coatings of hydroxyapatite<\/td><\/tr>

ISO 13779-4<\/a>:2018<\/b><\/p>

Implants for surgery – Hydroxyapatite – Part 4: Determination of coating adhesion strength<\/b><\/b><\/p><\/td>

Implants for surgery – Hydroxyapatite – Part 4: Determination of coating adhesion strength<\/td><\/tr>

ISO 13926-1<\/a>:2004<\/b><\/p>

Pen systems – Part 1: Glass cylinders for pen-injectors for medical use<\/b><\/b><\/p><\/td>

Pen systems – Part 1: Glass cylinders for pen-injectors for medical use<\/td><\/tr>

ISO 14242-1<\/a>:2014<\/b><\/p>

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<\/b><\/b><\/p><\/td>

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<\/td><\/tr>

ISO 14242-1<\/a>:2014\/Amd 1:2018<\/b><\/p>

Implants for surgery – Wear of total hip-joint prostheses \u2013 Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test \u2013 Amendment 1<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total hip-joint prostheses \u2013 Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test \u2013 Amendment 1<\/td><\/tr>

ISO 14242-2<\/a>:2016<\/b><\/p>

Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement<\/td><\/tr>

ISO 14242-4<\/a>:2018<\/b><\/p>

Implants for surgery – Wear of total hip-joint prostheses – Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total hip-joint prostheses – Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading<\/td><\/tr>

ISO 14243-1<\/a>:2009\/Amd 1:2020<\/b><\/p>

Implants for surgery – Wear of total knee-joint prostheses – Part\u00a01: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total knee-joint prostheses – Part\u00a01: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test<\/td><\/tr>

ISO 14243-2<\/a>:2016<\/b><\/p>

Implants for surgery – Wear of total knee-joint prostheses – Part\u00a02: Methods of measurement<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total knee-joint prostheses – Part\u00a02: Methods of measurement<\/td><\/tr>

ISO 14243-3<\/a>:2014\/Amd 1:2020<\/b><\/p>

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<\/b><\/b><\/p><\/td>

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<\/td><\/tr>

ISO 14243-5<\/a>:2019<\/b><\/p>

Implants for surgery – Wear of total knee prostheses – Part 5: Durability performance of the patellofemoral joint<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total knee prostheses – Part 5: Durability performance of the patellofemoral joint<\/td><\/tr>

ISO 14607:2018<\/b><\/p>

Non-active surgical implants \u2014 Mammary implants \u2014 Particular requirements<\/b><\/b><\/p><\/td>

Non-active surgical implants \u2014 Mammary implants \u2014 Particular requirements<\/td><\/tr>

ISO 14705<\/a>:2016<\/b><\/p>

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for hardness of monolithic ceramics at room temperature<\/b><\/b><\/p><\/td>

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for hardness of monolithic ceramics at room temperature<\/td><\/tr>

ISO 14801<\/a>:2016<\/b><\/p>

Dentistry – Implants – Dynamic loading test for endosseous dental implants<\/b><\/b><\/p><\/td>

Dentistry – Implants – Dynamic loading test for endosseous dental implants<\/td><\/tr>

ISO 14879-1<\/a>:2020<\/b><\/p>

Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays<\/b><\/b><\/p><\/td>

Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays<\/td><\/tr>

ISO 15142<\/a>-1:2003<\/b><\/p>

Implants for surgery – Metal intramedullary nailing systems – Part\u00a01: Intramedullary nails<\/b><\/b><\/p><\/td>

Implants for surgery – Metal intramedullary nailing systems – Part\u00a01: Intramedullary nails<\/td><\/tr>

ISO 15142-2<\/a>:2003<\/b><\/p>

Implants for surgery – Metal intramedullary nailing systems – Part\u00a02: Locking components<\/b><\/b><\/p><\/td>

Implants for surgery – Metal intramedullary nailing systems – Part\u00a02: Locking components<\/td><\/tr>

ISO 15142<\/a>-3:2003<\/b><\/p>

Implants for surgery – Metal intramedullary nailing systems – Part\u00a03: Connection devices and reamer diameter measurements<\/b><\/b><\/p><\/td>

Implants for surgery – Metal intramedullary nailing systems – Part\u00a03: Connection devices and reamer diameter measurements<\/td><\/tr>

ISO 15676:2016<\/b><\/p>

Cardiovascular implants and artificial organs – Requirements for single- use tubing packs for cardiopulmonary by pass and extracorporeal membrane oxygenation (ECMO)<\/b><\/b><\/p><\/td>

Cardiovascular implants and artificial organs – Requirements for single- use tubing packs for cardiopulmonary by pass and extracorporeal membrane oxygenation (ECMO)<\/td><\/tr>

ISO 15912<\/a>:2016<\/b><\/p>

Dentistry – Refractory investment and die material<\/b><\/b><\/p><\/td>

Dentistry – Refractory investment and die material<\/td><\/tr>

ISO 16061<\/a>:2021<\/b><\/p>

Instruments for use in association with non-active surgical implants \u2014 General requirements – 7.2 Pre-clinical evaluation<\/b><\/b><\/p><\/td>

Instruments for use in association with non-active surgical implants \u2014 General requirements – 7.2 Pre-clinical evaluation<\/td><\/tr>

ISO 16402<\/a>:2008<\/b><\/p>

Implants for surgery – Acrylic resin cement – Flexural fatigue testing of acrylic resin cements used in orthopaedics<\/b><\/b><\/p><\/td>

Implants for surgery – Acrylic resin cement – Flexural fatigue testing of acrylic resin cements used in orthopaedics<\/td><\/tr>

ISO 16429<\/a>:2004<\/b><\/p>

Implants for surgery – Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods<\/b><\/b><\/p><\/td>

Implants for surgery – Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods<\/td><\/tr>

ISO 17853<\/a>:2011<\/b><\/p>

Wear of implant materials – Polymer and metal wear particles – Isolation and characterization<\/b><\/b><\/p><\/td>

Wear of implant materials – Polymer and metal wear particles – Isolation and characterization<\/td><\/tr>

ISO 18192-1<\/a>:2011<\/b><\/p>

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<\/b><\/b><\/p><\/td>

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<\/td><\/tr>

ISO 18192-1<\/a>:2011\/Amd 1:2018<\/b><\/p>

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 \u2013 Amendment 1<\/b><\/b><\/p><\/td>

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 \u2013 Amendment 1<\/td><\/tr>

ISO 18192-2<\/a>:2010<\/b><\/p>

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 2: Nucleus replacements<\/b><\/b><\/p><\/td>

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 2: Nucleus replacements<\/td><\/tr>

ISO 18192-3<\/a>:2017<\/b><\/p>

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<\/b><\/b><\/p><\/td>

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<\/td><\/tr>

ISO 18754:2013<\/b><\/p>

Fine ceramics (advanced ceramics, advanced technical ceramics) – Determination of density and apparent porosity<\/b><\/b><\/p><\/td>

Fine ceramics (advanced ceramics, advanced technical ceramics) – Determination of density and apparent porosity<\/td><\/tr>
ISO 19023:2018-06 Dentistry – Orthodontic anchor screws<\/b><\/b><\/td>Dentistry – Orthodontic anchor screws<\/td><\/tr>

ISO 19213:2017<\/b><\/p>

Implants for surgery – Test methods of material for use as a cortical bone model<\/b><\/b><\/p><\/td>

Implants for surgery – Test methods of material for use as a cortical bone model<\/td><\/tr>

ISO 20160<\/a>:2006<\/b><\/p>

Implants for surgery – Metallic materials – Classification of microstructures for alpha+beta titanium alloy bars<\/b><\/b><\/p><\/td>

Implants for surgery – Metallic materials – Classification of microstructures for alpha+beta titanium alloy bars<\/td><\/tr>

ISO 21534<\/a>:2007<\/b><\/p>

Non-active surgical implants – Joint replacement implants – Particular requirements<\/b><\/b><\/p><\/td>

Non-active surgical implants – Joint replacement implants – Particular requirements<\/td><\/tr>

ISO 21535<\/a>:2023<\/b><\/p>

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants<\/b><\/b><\/p><\/td>

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants<\/td><\/tr>

ISO 21535<\/a>:2007\/Amd 1:2016<\/b><\/p>

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants<\/b><\/b><\/p><\/td>

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants<\/td><\/tr>

ISO 21536<\/a>:2023<\/b><\/p>

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants<\/b><\/b><\/p><\/td>

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants<\/td><\/tr>

ISO 21536<\/a>:2007\/Amd 1:2014<\/b><\/p>

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants<\/b><\/b><\/p><\/td>

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants<\/td><\/tr>

ISO 22214<\/a>:2006<\/b><\/p>

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for cyclic bending fatigue of monolithic ceramics at room temperature<\/b><\/b><\/p><\/td>

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for cyclic bending fatigue of monolithic ceramics at room temperature<\/td><\/tr>

ISO 22622<\/a>:2019<\/b><\/p>

Implants for surgery \u2014 Wear of total ankle-joint prostheses \u2014 Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test<\/b><\/b><\/p><\/td>

Implants for surgery \u2014 Wear of total ankle-joint prostheses \u2014 Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test<\/td><\/tr>

ISO 22675:2016<\/b><\/p>

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods<\/b><\/b><\/p><\/td>

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods<\/td><\/tr>

ISO 22683:2022<\/b><\/p>

Dentistry – Rotational adaptability test between implant body and implant abutment in dental implant systems<\/b><\/b><\/p><\/td>

Dentistry – Rotational adaptability test between implant body and implant abutment in dental implant systems<\/td><\/tr>

ISO 23089-2<\/a>:2021<\/b><\/p>

Implants for surgery \u2014 Pre-clinical mechanical assessment of spinal implants and particular requirements \u2014 Part 2: Spinal intervertebral body fusion devices<\/b><\/b><\/p><\/td>

Implants for surgery \u2014 Pre-clinical mechanical assessment of spinal implants and particular requirements \u2014 Part 2: Spinal intervertebral body fusion devices<\/td><\/tr>

ISO 25539-1<\/a>:2017<\/b><\/p>

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses<\/b><\/b><\/p><\/td>

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses<\/td><\/tr>

ISO 25539-2<\/a>:2020<\/b><\/p>

Cardiovascular implants – Endovascular devices – Part 2: Vascular stents<\/b><\/b><\/p><\/td>

Cardiovascular implants – Endovascular devices – Part 2: Vascular stents<\/td><\/tr>

ISO 29022:2013<\/b><\/p>

Dentistry \u2014 Adhesion \u2014 Notched-edge shear bond strength test<\/b><\/b><\/p><\/td>

Dentistry \u2014 Adhesion \u2014 Notched-edge shear bond strength test<\/td><\/tr>

ISO 4967<\/a>:2013<\/b><\/p>

Steel – Determination of content of non-metallic inclusions – Micrographic method using standard diagrams<\/b><\/b><\/p><\/td>

Steel – Determination of content of non-metallic inclusions – Micrographic method using standard diagrams<\/td><\/tr>

ISO 527-1:2019<\/b><\/p>

Plastics – Determination of tensile properties – Part 1: General principles<\/b><\/b><\/p><\/td>

Plastics – Determination of tensile properties – Part 1: General principles<\/td><\/tr>

ISO 5832-2:2018<\/b><\/p>

Implants for surgery \u2014 Metallic materials \u2014 Part 2: Unalloyed titanium<\/b><\/b><\/p><\/td>

Implants for surgery \u2014 Metallic materials \u2014 Part 2: Unalloyed titanium<\/td><\/tr>

ISO 5832-3<\/a>:2021<\/b><\/p>

Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy<\/b><\/b><\/p><\/td>

Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy<\/td><\/tr>
ISO 5832-4:2024 Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy<\/b><\/b><\/td>Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy<\/td><\/tr>

ISO 5833<\/a>:2002<\/b><\/p>

Implants for surgery – Acrylic resin cements<\/b><\/b><\/p><\/td>

Implants for surgery – Acrylic resin cements<\/td><\/tr>

ISO 5834-2:2019<\/b><\/p>

Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 2: Moulded forms<\/b><\/b><\/p><\/td>

Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 2: Moulded forms<\/td><\/tr>

ISO 5834-3<\/a>:2019<\/b><\/p>

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 3: Accelerated ageing methods<\/b><\/b><\/p><\/td>

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 3: Accelerated ageing methods<\/td><\/tr>

ISO 5838-1<\/a>:2013<\/b><\/p>

Implants for surgery – Skeletal pins and wires – Part 1: Material and mechanical requirements<\/b><\/b><\/p><\/td>

Implants for surgery – Skeletal pins and wires – Part 1: Material and mechanical requirements<\/td><\/tr>

ISO 5838-2<\/a>:1991<\/b><\/p>

Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions<\/b><\/b><\/p><\/td>

Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions<\/td><\/tr>

ISO 5838-3<\/a>:1993<\/b><\/p>

Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires<\/b><\/b><\/p><\/td>

Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires<\/td><\/tr>

ISO 6474-1<\/a>:2019<\/b><\/p>

Implants for surgery – Ceramic materials \u2013 Part 1: Ceramic materials based on high purity alumina<\/b><\/b><\/p><\/td>

Implants for surgery – Ceramic materials \u2013 Part 1: Ceramic materials based on high purity alumina<\/td><\/tr>

ISO 6474-2<\/a>:2019<\/b><\/p>

Implants for surgery – Ceramic materials \u2013 Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement<\/b><\/b><\/p><\/td>

Implants for surgery – Ceramic materials \u2013 Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement<\/td><\/tr>

ISO 6475:1989<\/b><\/p>

Implants for surgery – Metal bone screws with asymmetrical thread and spherical under-surface – Mechanical requirements and test methods<\/b><\/b><\/p><\/td>

Implants for surgery – Metal bone screws with asymmetrical thread and spherical under-surface – Mechanical requirements and test methods<\/td><\/tr>

ISO 6872<\/a>:2015+Amd1:2018<\/b><\/p>

Dentistry – Ceramic materials<\/b><\/b><\/p><\/td>

Dentistry – Ceramic materials<\/td><\/tr>

ISO 6892-1<\/a>:2019<\/b><\/p>

Metallic materials – Tensile testing – Part 1: Method of test at room temperature<\/b><\/b><\/p><\/td>

Metallic materials – Tensile testing – Part 1: Method of test at room temperature<\/td><\/tr>

ISO 7198<\/a>:2016<\/b><\/p>

Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches<\/b><\/b><\/p><\/td>

Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches<\/td><\/tr>

ISO 7206-1<\/a>:2008<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a01: Classification and designation of dimensions<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a01: Classification and designation of dimensions<\/td><\/tr>

ISO 7206-10<\/a>:2018\/Amd 1:2021<\/b><\/p>

Implants for surgery – Partial and total hip-joint prostheses – Part\u00a010: Determination of resistance to static load of modular femoral heads<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip-joint prostheses – Part\u00a010: Determination of resistance to static load of modular femoral heads<\/td><\/tr>

ISO 7206-10<\/a>:2018\/Amd 1:2021<\/b><\/p>

Implants for surgery – Partial and total hip-joint prostheses – Part\u00a010: Determination of resistance to static load of modular femoral heads<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip-joint prostheses – Part\u00a010: Determination of resistance to static load of modular femoral heads<\/td><\/tr>

ISO 7206-12<\/a>:2016<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells<\/td><\/tr>

ISO 7206-13<\/a>:2016<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a013: Determination of resistance to torque of head fixation of stemmed femoral components<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a013: Determination of resistance to torque of head fixation of stemmed femoral components<\/td><\/tr>

ISO 7206-13<\/a>:2016\/Amd1:2022<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses \u2013 Part\u00a013: Determination of resistance to torque of head fixation of stemmed femoral components – Amendment 1<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses \u2013 Part\u00a013: Determination of resistance to torque of head fixation of stemmed femoral components – Amendment 1<\/td><\/tr>

ISO 7206-2<\/a>:2011<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a02: Articulating surfaces made of metallic, ceramic and plastics materials<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a02: Articulating surfaces made of metallic, ceramic and plastics materials<\/td><\/tr>

ISO 7206-2<\/a>:2011\/Amd 1:2016<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a02: Articulating surfaces made of metallic, ceramic and plastics materials<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a02: Articulating surfaces made of metallic, ceramic and plastics materials<\/td><\/tr>

ISO 7206-4<\/a>:2010\/Amd 1:2017<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a04: Determination of endurance properties and performance of stemmed femoral components<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a04: Determination of endurance properties and performance of stemmed femoral components<\/td><\/tr>

ISO 7206-6<\/a>:2013<\/b><\/p>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a06: Endurance properties testing and performance requirements of neck region of stemmed femoral components<\/b><\/b><\/p><\/td>

Implants for surgery – Partial and total hip joint prostheses – Part\u00a06: Endurance properties testing and performance requirements of neck region of stemmed femoral components<\/td><\/tr>

ISO 7207-1<\/a>:2007<\/b><\/p>

Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification, definitions and designation of dimensions<\/b><\/b><\/p><\/td>

Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification, definitions and designation of dimensions<\/td><\/tr>
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<\/b><\/b><\/td>Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials<\/td><\/tr>
ISO 7207-2:2011\/Amd1:2016 Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials AMENDMENT 1<\/b><\/b><\/td>Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials AMENDMENT 1<\/td><\/tr>

ISO 7207-2<\/a>:2020\/Amd 2:2020<\/b><\/p>

Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials<\/b><\/b><\/p><\/td>

Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials<\/td><\/tr>

ISO 7438<\/a>:2020<\/b><\/p>

Metallic materials – Bend test<\/b><\/b><\/p><\/td>

Metallic materials – Bend test<\/td><\/tr>

ISO 7864:2016<\/b><\/p>

Sterile hypodermic needles for single use \u2014 Requirements and test methods<\/b><\/b><\/p><\/td>

Sterile hypodermic needles for single use \u2014 Requirements and test methods<\/td><\/tr>

ISO 80369-20<\/a>: 2015<\/b><\/p>

Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods<\/b><\/b><\/p><\/td>

Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods<\/td><\/tr>

ISO 9585<\/a>:1990<\/b><\/p>

Implants for surgery – Determination of bending strength and stiffness of bone plates<\/b><\/b><\/p><\/td>

Implants for surgery – Determination of bending strength and stiffness of bone plates<\/td><\/tr>

ISO 9626:2016<\/b><\/p>

Stainless steel needle tubing for the manufacture of medical devices \u2014 Requirements and test methods<\/b><\/b><\/p><\/td>

Stainless steel needle tubing for the manufacture of medical devices \u2014 Requirements and test methods<\/td><\/tr>

ISO\/TR 18130<\/a>:2016<\/b><\/p>

Dentistry – Screw loosening test using cyclic torsional loading for implant body\/implant abutment connection of endosseous dental implants<\/b><\/b><\/p><\/td>

Dentistry – Screw loosening test using cyclic torsional loading for implant body\/implant abutment connection of endosseous dental implants<\/td><\/tr>

ISO\/TS 13498<\/a>:2011<\/b><\/p>

Dentistry – Torsion test of implant body\/connecting part joints of endosseous dental implant systems<\/b><\/b><\/p><\/td>

Dentistry – Torsion test of implant body\/connecting part joints of endosseous dental implant systems<\/td><\/tr>

PI-11<\/a> : 2021-11<\/b><\/p>

Druckversuch statisch\/dynamisch Pfanneninserts<\/b><\/b><\/p><\/td>

Druckversuch statisch\/dynamisch Pfanneninserts<\/td><\/tr>

PI-14<\/a> : 2021-11<\/b><\/p>

Compression Test Hip Ball static\/dynamic<\/b><\/b><\/p><\/td>

Compression Test Hip Ball static\/dynamic<\/td><\/tr>

PI-17<\/a> : 2018-10<\/b><\/p>

Determination of Total Knee Implant Contact Pressure<\/b><\/b><\/p><\/td>

Determination of Total Knee Implant Contact Pressure<\/td><\/tr>

PI-19<\/a> : 2018-10<\/b><\/p>

Gliding Nail Fatigue Test<\/b><\/b><\/p><\/td>

Gliding Nail Fatigue Test<\/td><\/tr>

PI-27\u00a0: 2014-11<\/b><\/p>

Pen Injector 60 IU Stop<\/b><\/b><\/p><\/td>

Pen Injector 60 IU Stop<\/td><\/tr>

PI-28 : 2014-11<\/b><\/p>

Pen Injector 300 IU Stop<\/b><\/b><\/p><\/td>

Pen Injector 300 IU Stop<\/td><\/tr>

PI-29 : 2014-11<\/b><\/p>

Pen Injector Fluid Solvent Exposure<\/b><\/b><\/p><\/td>

Pen Injector Fluid Solvent Exposure<\/td><\/tr>

PI-3<\/a>: 2017-01<\/b><\/p>

Luxationsversuch 2 (LUX2)<\/b><\/b><\/p><\/td>

Luxationsversuch 2 (LUX2)<\/td><\/tr>

PI-30 : 2014-11<\/b><\/p>

Pen Injector Dose accuracy different dose pattern<\/b><\/b><\/p><\/td>

Pen Injector Dose accuracy different dose pattern<\/td><\/tr>

PI-31 : 2014-11<\/b><\/p>

Pen Injector Drop Test Resistance with Increased Demands<\/b><\/b><\/p><\/td>

Pen Injector Drop Test Resistance with Increased Demands<\/td><\/tr>

PI-32 : 2014-11<\/b><\/p>

Pen Injector Cap Removal Force Test<\/b><\/b><\/p><\/td>

Pen Injector Cap Removal Force Test<\/td><\/tr>

PI-33 : 2014-11<\/b><\/p>

Pen Injector Needle Cover Interference<\/b><\/b><\/p><\/td>

Pen Injector Needle Cover Interference<\/td><\/tr>

PI-35 : 2014-11<\/b><\/p>

Pen Injector Dispense Force Test<\/b><\/b><\/p><\/td>

Pen Injector Dispense Force Test<\/td><\/tr>

PI-36 : 2014-11<\/b><\/p>

Pen Injector Dialing torque to set a dose<\/b><\/b><\/p><\/td>

Pen Injector Dialing torque to set a dose<\/td><\/tr>

PI-37 : 2014-11<\/b><\/p>

Pen Injector Dial Stop Torque 0 I.U.<\/b><\/b><\/p><\/td>

Pen Injector Dial Stop Torque 0 I.U.<\/td><\/tr>

PI-38 : 2014-11<\/b><\/p>

Pen Injector Dose number character height Dose Window Distortion<\/b><\/b><\/p><\/td>

Pen Injector Dose number character height Dose Window Distortion<\/td><\/tr>

PI-39 : 2014-11<\/b><\/p>

Pen Injector Dose accuracy after dial stop break torque<\/b><\/b><\/p><\/td>

Pen Injector Dose accuracy after dial stop break torque<\/td><\/tr>

PI-40 : 2014-11<\/b><\/p>

Pen Injector Disassembly Force Test<\/b><\/b><\/p><\/td>

Pen Injector Disassembly Force Test<\/td><\/tr>

PI-41 : 2014-11<\/b><\/p>

Pen Injector Dust Ingress<\/b><\/b><\/p><\/td>

Pen Injector Dust Ingress<\/td><\/tr>

PI-52<\/a> : 2015-10<\/b><\/p>

Expulsion test – spinal implants<\/b><\/b><\/p><\/td>

Expulsion test – spinal implants<\/td><\/tr>

PI-53<\/a> : 2010-11<\/b><\/p>

Fatigue testing of stemmed femoral TKA components<\/b><\/b><\/p><\/td>

Fatigue testing of stemmed femoral TKA components<\/td><\/tr>

PI-54 : 2010-11<\/b><\/p>

Mechanical Test – VBR spinal implants<\/b><\/b><\/p><\/td>

Mechanical Test – VBR spinal implants<\/td><\/tr>

PI-57 : 2013-10<\/b><\/p>

DIN EN 12006-3 : 2009-08 – Nichtaktive chirurgische Implantate – Besondere Anforderungen an Herz- und Gef\u00e4\u00dfimplantate – Teil 3: Blutgef\u00e4\u00dfstents und Hohlvenenfilter<\/b><\/b><\/p><\/td>

DIN EN 12006-3 : 2009-08 – Nichtaktive chirurgische Implantate – Besondere Anforderungen an Herz- und Gef\u00e4\u00dfimplantate – Teil 3: Blutgef\u00e4\u00dfstents und Hohlvenenfilter<\/td><\/tr>

PI-58<\/a> :2013-10<\/b><\/p>

ISO 7206-8 – Endurance performance of stemmed femoral components with application of torsion<\/b><\/b><\/p><\/td>

ISO 7206-8 – Endurance performance of stemmed femoral components with application of torsion<\/td><\/tr>

PI-60<\/a> : 2014-10<\/b><\/p>

ISO 6474 (1994): Implants for surgery – Ceramic materials based on high purity alumina<\/b><\/b><\/p><\/td>

ISO 6474 (1994): Implants for surgery – Ceramic materials based on high purity alumina<\/td><\/tr>

PI-61<\/a> : 2021-12<\/b><\/p>

Reverse Shoulder System Wear Test<\/b><\/b><\/p><\/td>

Reverse Shoulder System Wear Test<\/td><\/tr>

PI-62<\/a> : 2014-10<\/b><\/p>

Anatomic Shoulder System Wear Test<\/b><\/b><\/p><\/td>

Anatomic Shoulder System Wear Test<\/td><\/tr>

PI-64<\/a> : 2016-04<\/b><\/p>

Total hip joint prostheses – 3D Frictional torque<\/b><\/b><\/p><\/td>

Total hip joint prostheses – 3D Frictional torque<\/td><\/tr>

PI-65<\/a>: 2018-10<\/b><\/p>

Determination of Total Ankle Replacement Contact Pressure<\/b><\/b><\/p><\/td>

Determination of Total Ankle Replacement Contact Pressure<\/td><\/tr>

PI-68<\/a>: 2019-04<\/b><\/p>

(WK52025) Standard Test Method for Metallic Bone Plates Used in Small Bone Fracture Fixation<\/b><\/b><\/p><\/td>

(WK52025) Standard Test Method for Metallic Bone Plates Used in Small Bone Fracture Fixation<\/td><\/tr>

PI-70: 2016-02<\/b><\/p>

(WK28214) Practice for Accelerated Fretting Corrosion Testing of Modular Head and Neck Taper Junctions Used in Total Hip Replacement<\/b><\/b><\/p><\/td>

(WK28214) Practice for Accelerated Fretting Corrosion Testing of Modular Head and Neck Taper Junctions Used in Total Hip Replacement<\/td><\/tr>

PI-76<\/a>: 2016-02<\/b><\/p>

(WK45142) Standard Practice for Mechanical Characterization of Spinous Process Plates<\/b><\/b><\/p><\/td>

(WK45142) Standard Practice for Mechanical Characterization of Spinous Process Plates<\/td><\/tr>

PI-82<\/a>: 2018-10<\/b><\/p>

Determination of Screw Compression Force<\/b><\/b><\/p><\/td>

Determination of Screw Compression Force<\/td><\/tr>

PI-85: 2022-01<\/b><\/p>

(ISO 14607:2007 (Part 7.2.2.5.4 (Annex E.3)) Mammary Implants – Static and Fatigue Rupture Test<\/b><\/b><\/p><\/td>

(ISO 14607:2007 (Part 7.2.2.5.4 (Annex E.3)) Mammary Implants – Static and Fatigue Rupture Test<\/td><\/tr>

PI-86: 2022-01<\/b><\/p>

FEA ASTM F2582 worst-case determination impingement between polyethylene acetabular liner and metallic shell<\/b><\/b><\/p><\/td>

FEA ASTM F2582 worst-case determination impingement between polyethylene acetabular liner and metallic shell<\/td><\/tr>

PI-87: 2022-01<\/b><\/p>

FEA ISO 7206-6 femoral stem neck test<\/b><\/b><\/p><\/td>

FEA ISO 7206-6 femoral stem neck test<\/td><\/tr>

PI-89<\/a>: 2022-12<\/b><\/p>

Implants for Surgery – Partial and total shoulder joint prosthesis Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres<\/b><\/b><\/p><\/td>

Implants for Surgery – Partial and total shoulder joint prosthesis Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres<\/td><\/tr>

PI-90<\/a>: 2022-12<\/b><\/p>

Implants for Surgery – Partial and total shoulder joint prosthesis Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses<\/b><\/b><\/p><\/td>

Implants for Surgery – Partial and total shoulder joint prosthesis Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses<\/td><\/tr>

PI-91<\/a>: 2022-01<\/b><\/p>

Fatigue testing of transfemoral fixations<\/b><\/b><\/p><\/td>

Fatigue testing of transfemoral fixations<\/td><\/tr>

PI-92: 2022-12<\/b><\/p>

Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants<\/b><\/b><\/p><\/td>

Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants<\/td><\/tr>

PI-94: 2024-01<\/b><\/p>

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures<\/b><\/b><\/p><\/td>

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures<\/td><\/tr>

PI-95: 2024-06<\/b><\/p>

Standard Specification for Resurfacing Patellar Prosthesis<\/b><\/b><\/p><\/td>

Standard Specification for Resurfacing Patellar Prosthesis<\/td><\/tr>

PI-96: 2024-06<\/b><\/p>

Standard Specification for Knee Replacement Prosthesis<\/b><\/b><\/p><\/td>

Standard Specification for Knee Replacement Prosthesis<\/td><\/tr>

PI-97: 2024-06<\/b><\/p>

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants<\/b><\/b><\/p><\/td>

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants<\/td><\/tr>

PI-98: 2024-06<\/b><\/p>

Standard Specification for Femoral Prostheses-Metallic Implants<\/b><\/b><\/p><\/td>

Standard Specification for Femoral Prostheses-Metallic Implants<\/td><\/tr>

PI-99: 2024-06<\/b><\/p>

Standard Specification for Acetabular Prostheses<\/b><\/b><\/p><\/td>

Standard Specification for Acetabular Prostheses<\/td><\/tr>

PI-100: 2024-07<\/b><\/p>

Implants for surgery – Bone anchoring systems – Part 1: Impact, expandable and threaded suture anchors requirements<\/b><\/b><\/p><\/td>

Implants for surgery – Bone anchoring systems – Part 1: Impact, expandable and threaded suture anchors requirements<\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t\t
\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Scope of certification Test laboratory for medical devices according to ISO 17025 Certificate Scope View our Certificate and Scope ASME V&V40 – 2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices ANSI\/AAMI NS 28 1988\/I 2006 Intracranial […]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-5423","page","type-page","status-publish","hentry"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"Kilian Pallauf","author_link":"https:\/\/endolab.org\/de\/author\/kilian-pallauf\/"},"uagb_comment_info":0,"uagb_excerpt":"Scope of certification Test laboratory for medical devices according to ISO 17025 Certificate Scope View our Certificate and Scope ASME V&V40 – 2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices ANSI\/AAMI NS 28 1988\/I 2006 Intracranial…","_links":{"self":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/pages\/5423","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/comments?post=5423"}],"version-history":[{"count":97,"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/pages\/5423\/revisions"}],"predecessor-version":[{"id":11055,"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/pages\/5423\/revisions\/11055"}],"wp:attachment":[{"href":"https:\/\/endolab.org\/de\/wp-json\/wp\/v2\/media?parent=5423"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}