Scope of certification

Test laboratory for medical devices according to ISO 17025

View our Certificate and Scope

ANSI/AAMI NS 28 : 1988/I 2006

Intracranial pressure monitoring devices

Intracranial pressure monitoring devices

ASTM D2990 – 17

Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics

Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics

ASTM D570 – 22

Standard Test Method for Water Absorption of Plastics

Standard Test Method for Water Absorption of Plastics

ASTM D618 – 21

Standard Practice for Conditioning Plastics for Testing

Standard Practice for Conditioning Plastics for Testing

ASTM D638 – 22

Standard Test Method for Tensile Properties of Plastics

Standard Test Method for Tensile Properties of Plastics

ASTM D732 – 17

Standard Test Method for Shear Strength of Plastics by Punch Tool

Standard Test Method for Shear Strength of Plastics by Punch Tool

ASTM D790 – 17

Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

Standard Test Method for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

ASTM D792 – 20

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

ASTM D882 – 18

Standard Test Method for Tensile Properties of Thin Plastic Sheeting

Standard Test Method for Tensile Properties of Thin Plastic Sheeting

ASTM E112 – 13(2021)

Standard Test Methods for Determining Average Grain Size

Standard Test Methods for Determining Average Grain Size

ASTM E1920 – 03 (Reapproved 2021)

Standard Guide for Metallographic Preparation of Thermal Sprayed Coatings

Standard Guide for Metallographic Preparation of Thermal Sprayed Coatings

ASTM E252 – 06(2021)

Standard Test Method for Thickness of Foil, Thin Sheet, and Film by Mass Measurement

Standard Test Method for Thickness of Foil, Thin Sheet, and Film by Mass Measurement

ASTM F1044 – 05(2017)

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

ASTM F1089 – 18

Standard Test Method for Corrosion of Surgical Instruments

Standard Test Method for Corrosion of Surgical Instruments

ASTM F1147 – 05(2017)

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

ASTM F1160 – 14(2017)

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

ASTM F1223 – 20

Standard Test Method for Determination of Total Knee Replacement Constraint

Standard Test Method for Determination of Total Knee Replacement Constraint

ASTM F1264 – 16e

Standard Specification and Test Methods for Intramedullary Fixation Devices

Standard Specification and Test Methods for Intramedullary Fixation Devices

ASTM F1357 – 14(2019)

Standard Specification for Articulating Total Wrist Implants

Standard Specification for Articulating Total Wrist Implants

ASTM F136 – 13(2021)

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F1378 – 18e1

Standard Specification for Shoulder Prostheses

Standard Specification for Shoulder Prostheses

ASTM F1541 – 17

Standard Specification and Test Methods for External Skeletal Fixation Devices

Standard Specification and Test Methods for External Skeletal Fixation Devices

ASTM F1582 – 98(2016)

Standard Terminology Relating to Spinal Implants

Standard Terminology Relating to Spinal Implants

ASTM F1609 – 08(2014)

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ASTM F1635 – 16

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

ASTM F1672 – 14(2019)

Standard Specification for Resurfacing Patellar Prosthesis

Standard Specification for Resurfacing Patellar Prosthesis

ASTM F1714 – 96(2018)

Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices

Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices

ASTM F1717 – 21

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

ASTM F1781 – 21

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

ASTM F1798 – 21

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

ASTM F1800 – 19e

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

ASTM F1801 – 20

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

ASTM F1814 – 22

Standard Guide for Evaluating Modular Hip and Knee Joint Components

Standard Guide for Evaluating Modular Hip and Knee Joint Components

ASTM F1820 – 22

Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device

Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device

ASTM F1828 – 17

Standard Specification for Ureteral Stents

Standard Specification for Ureteral Stents

ASTM F1829 – 17

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

ASTM F1839 – 08(2021)

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

ASTM F1854 – 15

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

ASTM F1875 – 98(2022)

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

ASTM F1877 – 16

Standard Practice for Characterization of Particles

Standard Practice for Characterization of Particles

ASTM F1926/F1926M – 14(2021)

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

ASTM F1978 – 22

Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

ASTM F1980 – 21

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F2003 – 02(2015)

Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene

Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene

ASTM F2009 – 20

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

ASTM F2025 – 06(2018)

Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

ASTM F2028 – 17

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

ASTM F2033 – 20

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

ASTM F2051 – 00 (Reapproved 2022)

Standard Specification for Implantable Saline Filled Breast Prosthesis – Part 9.2.2 (Shell Leakage Testing)

Standard Specification for Implantable Saline Filled Breast Prosthesis – Part 9.2.2 (Shell Leakage Testing)

ASTM F2051 – 00 (Reapproved 2022)

Standard Specification for Implantable Saline Filled Breast Prosthesis – Part 9.2.3 (Shell)

Standard Specification for Implantable Saline Filled Breast Prosthesis – Part 9.2.3 (Shell)

ASTM F2051 – 00 (Reapproved 2022)

Standard Specification for Implantable Saline Filled Breast Prosthesis – Part 9.5 (Abrasion Testing)

Standard Specification for Implantable Saline Filled Breast Prosthesis – Part 9.5 (Abrasion Testing)

ASTM F2068 – 15

Standard Specification for Femoral Prostheses – Metallic Implants

Standard Specification for Femoral Prostheses – Metallic Implants

ASTM F2077 – 22

Test method for intervertebral body fusion devices

Test method for intervertebral body fusion devices

ASTM F2079 – 09(2022)

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM F2081 – 06(2022)

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM F2083 – 21

Standard Specification for Total Knee Prosthesis

Standard Specification for Total Knee Prosthesis

ASTM F2091 – 15

Standard Specification for Acetabular Prostheses

Standard Specification for Acetabular Prostheses

ASTM F2118 – 14(2020)

Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

ASTM F2129 – 19a

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

ASTM F2180 – 17

Standard Specification for Metallic Implantable Strands and Cables

Standard Specification for Metallic Implantable Strands and Cables

ASTM F2193 – 20

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

ASTM F2217/F2217M – 13(2018)

Standard Practice for Coating/Adhesive Weight Determination

Standard Practice for Coating/Adhesive Weight Determination

ASTM F2267 – 22

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

ASTM F2345 – 21

Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

ASTM F2346 – 18

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

ASTM F2394 – 07(2022)

Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System

Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System

ASTM F2423 – 11(2020)

Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses

Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses

ASTM F2477 – 19

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2502 – 17

Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants

Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants

ASTM F2514 – 21

Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM F2516 – 22

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

ASTM F2528 – 06(2014)

Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

ASTM F2580 – 18

Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

ASTM F2582 – 20

Standard Test Method for Impingement of Acetabular Prostheses

Standard Test Method for Impingement of Acetabular Prostheses

ASTM F2606 – 08(2021)

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ASTM F2624 – 12(2020)

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

ASTM F2665 – 21

Standard Specification for Total Ankle Replacement Prosthesis

Standard Specification for Total Ankle Replacement Prosthesis

ASTM F2694 – 16(2020)

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

ASTM F2706 – 18

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

ASTM F2722 – 21

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops

ASTM F2723 – 21

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation

ASTM F2724 – 21

Standard Test Method for Evaluating Mobile Bearing Knee Dislocation

Standard Test Method for Evaluating Mobile Bearing Knee Dislocation

ASTM F2743 – 11(2018)

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

ASTM F2777 – 16

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

ASTM F2789 – 10(2020)

Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

ASTM F2790 – 10(2019)e

Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

ASTM F2791 – 15

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

ASTM F2824 – 10(2020)

Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids

Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids

ASTM F2887 – 17

Standard Specification for Total Elbow Prostheses

Standard Specification for Total Elbow Prostheses

ASTM F2902 – 16e

Standard Guide for Assessment of Absorbable Polymeric

Standard Guide for Assessment of Absorbable Polymeric

ASTM F2942 – 19

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F2952 – 14

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

ASTM F2979 – 20

Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses

Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses

ASTM F2996 – 20

Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

ASTM F3014 – 14

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

ASTM F3018 – 17

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices

ASTM F3036 – 21

Standard Guide for Testing Absorbable Stents

Standard Guide for Testing Absorbable Stents

ASTM F3044 – 20

Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

ASTM F3047M – 15

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

ASTM F3067 – 14(2021)

Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents

ASTM F3087 – 15

Standard Specification for Acrylic Molding Resin for Medical Implant Applications

Standard Specification for Acrylic Molding Resin for Medical Implant Applications

ASTM F3090 – 20

Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement

Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement

ASTM F3140 – 17

Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

ASTM F3141 – 17a

Standard Guide for Total Knee Replacement Loading Profiles

Standard Guide for Total Knee Replacement Loading Profiles

ASTM F3143 – 20

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator

ASTM F3161 – 16

Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions

Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions

ASTM F3172 – 15(2021)

Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

ASTM F3210 – 22e1

Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions

Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions

ASTM F3211 – 17

Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices

Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices

ASTM F3295 – 18

Standard Guide for Impingement Testing of Total Disc Prostheses

Standard Guide for Impingement Testing of Total Disc Prostheses

ASTM F3334 – 19

Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components

Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components

ASTM F3335 – 20

Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

ASTM F3446 – 20

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator

Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator

ASTM F3505 – 21

Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance

Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance

ASTM F3574 – 22

Standard Test Methods for Sacroiliac Joint Fusion Devices

Standard Test Methods for Sacroiliac Joint Fusion Devices

ASTM F366 – 17

Standard Specification for Fixation Pins and Wires

Standard Specification for Fixation Pins and Wires

ASTM F382 – 17

Standard Specification and Test Method for Metallic Bone Plates

Standard Specification and Test Method for Metallic Bone Plates

ASTM F384 – 17

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

ASTM F451 – 21

Standard Specification for Acrylic Bone Cement

Standard Specification for Acrylic Bone Cement

ASTM F543 – 17

Standard Specification and Test Methods for Metallic Medical Bone Screws

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F561 – 19

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

ASTM F564 – 17

Standard Specification and Test Methods for Metallic Bone Staples

Standard Specification and Test Methods for Metallic Bone Staples

ASTM F601 – 18

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

ASTM F648 – 21

Ultra-High-Molecular-Weight Polyethylene Powder and Standard Specification for Fabricated Form for Surgical Implants

Ultra-High-Molecular-Weight Polyethylene Powder and Standard Specification for Fabricated Form for Surgical Implants

ASTM F703 – 18(2022)

Standard Specification for Implantable Breast Prostheses – Part 10.2 (Gel Penetration Test Method)

Standard Specification for Implantable Breast Prostheses – Part 10.2 (Gel Penetration Test Method)

ASTM F703 – 18(2022)

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.3 (Silicone Gel Test Method)

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.3 (Silicone Gel Test Method)

ASTM F703 – 18(2022)

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.4 (Gel Cohesion)

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.4 (Gel Cohesion)

ASTM F703 – 18(2022)

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.5 (Gel Bleed Test Method)

Standard Specification for Implantable Breast Prostheses – Part 9.2.1.5 (Gel Bleed Test Method)

ASTM F732 – 17

Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

ASTM F746 – 04(2021)

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

ASTM F88/F88M – 21

Standard Test Method for Seal Strength of Flexible Barrier Materials

Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F897 – 19

Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

ASTM G102 – 89(2015)e

Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements

Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements

DIN 50113:2018

Prüfung metallischer Werkstoffe – Umlaufbiegeversuch

Prüfung metallischer Werkstoffe – Umlaufbiegeversuch

DIN 50134:2008-10

Prüfung von metallischen Werkstoffen – Druckversuch an metallischen zellularen Werkstoffen

Prüfung von metallischen Werkstoffen – Druckversuch an metallischen zellularen Werkstoffen

DIN EN 455-2:2015-07

Medical gloves for single use – Part 2: Requirements and testing for physical properties

Medical gloves for single use – Part 2: Requirements and testing for physical properties

DIN EN 843-2:2007-03

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil 2: Bestimmung des Elastizitätsmoduls, Schubmoduls und der Poissonzahl

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil 2: Bestimmung des Elastizitätsmoduls, Schubmoduls und der Poissonzahl

DIN EN 843-4:2005-08

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil 4: Härteprüfung nach Vickers, Knoop und Rockwell

Hochleistungskeramik – Mechanische Eigenschaften monolithischer Keramik bei Raumtemperatur – Teil 4: Härteprüfung nach Vickers, Knoop und Rockwell

DIN EN ISO 10328:2016-12

Prothetik – Prüfung der Struktur von Prothesen der unteren Gliedmaßen – Anforderungen und Prüfverfahren (ISO 10328:2016)

Prothetik – Prüfung der Struktur von Prothesen der unteren Gliedmaßen – Anforderungen und Prüfverfahren (ISO 10328:2016)

DIN EN ISO 10555-1:2018

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013 + Amd 1:2017)

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013 + Amd 1:2017)

DIN EN ISO 10555-3:2013-11

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 3: Zentrale venöse Katheter (ISO 10555-3:2013)

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 3: Zentrale venöse Katheter (ISO 10555-3:2013)

DIN EN ISO 10555-4:2013-11

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 4: Ballondilatationskatheter (ISO 10555-4:2013)

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 4: Ballondilatationskatheter (ISO 10555-4:2013)

DIN EN ISO 10555-5:2013-11

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 5: Periphere Katheter mit innen liegender Kanüle (ISO 10555-5:2013)

Intravaskuläre Katheter – Sterile Katheter zur einmaligen Verwendung – Teil 5: Periphere Katheter mit innen liegender Kanüle (ISO 10555-5:2013)

DIN EN ISO 11070:2019-04

Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO 11070:2014 + Amd 1:2018)

Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO 11070:2014 + Amd 1:2018)

DIN EN ISO 11607-1:2017-10

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte – Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte – Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme

DIN EN ISO 11608-1:2022-09

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 1: Kanülenbasierte Injektionssysteme (ISO 11608-1:2022)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 1: Kanülenbasierte Injektionssysteme (ISO 11608-1:2022)

DIN EN ISO 11608-2:2022-09

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 2: Kanülen (ISO 11608-2:2022)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 2: Kanülen (ISO 11608-2:2022)

DIN EN ISO 11608-3:2022-09

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 3: Fertigbehälter (ISO 11608-3:2022)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 3: Fertigbehälter (ISO 11608-3:2022)

DIN EN ISO 11608-4:2022-09

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO 11608-4:2022)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile enthalten (ISO 11608-4:2022)

DIN EN ISO 11608-5:2022-11

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)

Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)

DIN EN ISO 11953:2010-11

Klinisches Verhalten manuell angewandter Drehmomentschlüssel

Klinisches Verhalten manuell angewandter Drehmomentschlüssel

DIN EN ISO 13356:2016-02

Chirurgische Implantate – Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP) (ISO 13356:2015)

Chirurgische Implantate – Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkondioxid (Y-TZP) (ISO 13356:2015)

DIN EN ISO 13402:2001-02

Chirurgische und zahnärztliche Handinstrumente – Bestimmung der Beständigkeit gegenüber Sterilisation, Korrosion und Wärmebehandlung (ISO 13402:1995)

Chirurgische und zahnärztliche Handinstrumente – Bestimmung der Beständigkeit gegenüber Sterilisation, Korrosion und Wärmebehandlung (ISO 13402:1995)

DIN EN ISO 14607:2018

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.2.1 / Anhang B.1 & B.2 (Prüfung auf Unversehrtheit der Hülle)

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.2.1 / Anhang B.1 & B.2 (Prüfung auf Unversehrtheit der Hülle)

DIN EN ISO 14607:2018

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.2.2.1 / Anhang C.1 (Ermüdungsprüfung)

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.2.2.1 / Anhang C.1 (Ermüdungsprüfung)

DIN EN ISO 14607:2018

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.2.2.2 / Anhang C.2 (Aufprallprüfung)

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.2.2.2 / Anhang C.2 (Aufprallprüfung)

DIN EN ISO 14607:2018

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.3.3.2 / Anhang E (Kohäsionsprüfung Silikongel)

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.3.3.2 / Anhang E (Kohäsionsprüfung Silikongel)

DIN EN ISO 14607:2018

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.3.3.3 / Anhang F (Penetration von Silikongel)

Nichtaktive chirurgische Implantate – Mammaimplantate – Besondere Anforderungen – Part 7.2.3.3.3 / Anhang F (Penetration von Silikongel)

DIN EN ISO 14801:2017-03

Zahnheilkunde – Implantate – Dynamische Belastungsprüfung für enossale Dentalimplantate (ISO 14801:2016)

Zahnheilkunde – Implantate – Dynamische Belastungsprüfung für enossale Dentalimplantate (ISO 14801:2016)

DIN EN ISO 15912:2016-08

Zahnheilkunde – Einbettmassen und hochtemperaturbeständige Stumpfmaterialien (ISO 15912:2016)

Zahnheilkunde – Einbettmassen und hochtemperaturbeständige Stumpfmaterialien (ISO 15912:2016)

DIN EN ISO 16061:2021

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden – Allgemeine Anforderungen (ISO 16061:2021) – 7.2 Präklinische Bewertung

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden – Allgemeine Anforderungen (ISO 16061:2021) – 7.2 Präklinische Bewertung

DIN EN ISO 21534:2009-08

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen (ISO 21534:2007)

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen (ISO 21534:2007)

DIN EN ISO 21535:2017-04

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007 + Amd 1:2016)

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007 + Amd 1:2016)

DIN EN ISO 21536:2014-07

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2007 + Amd.1:2014)

Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate für den Kniegelenkersatz (ISO 21536:2007 + Amd.1:2014)

DIN EN ISO 22675:2016-12

Prothetik – Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten – Anforderungen und Prüfverfahren (ISO 22675:2016)

Prothetik – Prüfung von Knöchel-Fuß-Passteilen und Fußeinheiten – Anforderungen und Prüfverfahren (ISO 22675:2016)

DIN EN ISO 25539-1:2017-09

Kardiovaskuläre Implantate – Endovaskuläre Implantate – Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2017)

Kardiovaskuläre Implantate – Endovaskuläre Implantate – Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2017)

DIN EN ISO 25539-2:2021

Kardiovaskuläre Implantate – Endovaskuläre Implantate – Teil 2: Gefäßstents (ISO 25539-2:2020)

Kardiovaskuläre Implantate – Endovaskuläre Implantate – Teil 2: Gefäßstents (ISO 25539-2:2020)

DIN EN ISO 29022:2013

Zahnheilkunde – Adhäsion – Prüfung der Abscherverbundfestigkeit mit einer ausgesparten Klinge (ISO 29022:2013)

Zahnheilkunde – Adhäsion – Prüfung der Abscherverbundfestigkeit mit einer ausgesparten Klinge (ISO 29022:2013)

DIN EN ISO 527-1:2012-06

Bestimmung der Zugeigenschaften – Teil 1: Allgemeine Grundsätze

Bestimmung der Zugeigenschaften – Teil 1: Allgemeine Grundsätze

DIN EN ISO 5832-2:2018

Chirurgische Implantate – Metallische Werkstoffe – Teil 2: Unlegiertes Titan (ISO 5832-2:2018)

Chirurgische Implantate – Metallische Werkstoffe – Teil 2: Unlegiertes Titan (ISO 5832-2:2018)

DIN EN ISO 5832-3:2022

Chirurgische Implantate – Metallische Werkstoffe – Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO 5832-3:2021)

Chirurgische Implantate – Metallische Werkstoffe – Teil 3: Titan 6-Aluminium 4-Vanadium Knetlegierung (ISO 5832-3:2021)

DIN EN ISO 643:2013-05

Stahl – Mikrophotographische Bestimmung der erkennbaren Korngröße (ISO 643:2012)

Stahl – Mikrophotographische Bestimmung der erkennbaren Korngröße (ISO 643:2012)

DIN EN ISO 6872:2015-11

Zahnheilkunde – Keramische Werkstoffe (ISO 6872:2015)

Zahnheilkunde – Keramische Werkstoffe (ISO 6872:2015)

DIN EN ISO 6892-1:2017-02

Metallische Werkstoffe – Zugversuch – Teil 1: Prüfverfahren bei Raumtemperatur (ISO 6892-1:2016)

Metallische Werkstoffe – Zugversuch – Teil 1: Prüfverfahren bei Raumtemperatur (ISO 6892-1:2016)

DIN EN ISO 7198:2017-07

Kardiovaskuläre Implantate und extrakorporale Systeme – Vaskuläre Prothesen – Tubulare vaskuläre Transplantate und Gefäßpatches (ISO 7198:2016)

Kardiovaskuläre Implantate und extrakorporale Systeme – Vaskuläre Prothesen – Tubulare vaskuläre Transplantate und Gefäßpatches (ISO 7198:2016)

DIN EN ISO 7864:2016-12

Sterile Injektionskanülen für den Einmalgebrauch – Anforderungen und Prüfverfahren (ISO 7864:2016)

Sterile Injektionskanülen für den Einmalgebrauch – Anforderungen und Prüfverfahren (ISO 7864:2016)

DIN EN ISO 80369-20:2015-09

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen – Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen – Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2015)

DIN EN ISO 9626:2016

Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten – Anforderungen und Prüfverfahren (ISO 9626:2016)

Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten – Anforderungen und Prüfverfahren (ISO 9626:2016)

DIN ISO 13926-1:2005-10

Pen-Systeme – Teil 1: Glaszylinder für Pen-Injektoren zur medizinischen Verwendung (ISO 13926-1:2004)

Pen-Systeme – Teil 1: Glaszylinder für Pen-Injektoren zur medizinischen Verwendung (ISO 13926-1:2004)

DIN ISO 5832-4:2015-12

Chirurgische Implantate – Metallische Werkstoffe – Teil 4: Kobalt-Chrom-Molybdän-Gusslegierung (ISO 5832-4:2014)

Chirurgische Implantate – Metallische Werkstoffe – Teil 4: Kobalt-Chrom-Molybdän-Gusslegierung (ISO 5832-4:2014)

DIN ISO 5834-2:2020

Chirurgische Implantate – Ultrahochmolekulares Polyethylen – Teil 2: Halbzeuge (ISO 5834-2:2019)

Chirurgische Implantate – Ultrahochmolekulares Polyethylen – Teil 2: Halbzeuge (ISO 5834-2:2019)

ISO 10328:2016

Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods

Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods

ISO 10555-1:2013

Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements

Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements

ISO 10555-1:2013/Amd 1:2017

Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements

Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements

ISO 10555-3:2013

Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters

Intravascular catheters – Sterile and single-use catheters – Part 3: Central venous catheters

ISO 10555-4:2013

Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters

Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters

ISO 10555-5:2013

Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters

Intravascular catheters – Sterile and single-use catheters – Part 5: Over-needle peripheral catheters

ISO 11070:2014

Sterile single-use intravascular introducers, dilators and guidewires

Sterile single-use intravascular introducers, dilators and guidewires

ISO 1143:2021

Metallic materials – Rotating bar bending fatigue testing

Metallic materials – Rotating bar bending fatigue testing

ISO 11491:2017

Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses

Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses

ISO 11608-1:2022

Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems

Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems

ISO 11608-2:2022

Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles

Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles

ISO 11608-3:2022

Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers

Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers

ISO 11608-4:2022

Pen-injectors for medical use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

Pen-injectors for medical use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

ISO 11608-5:2022

Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions

Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions

ISO 12189:2008

Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support

Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support

ISO 13175-3:2012

Implants for surgery – Calcium phosphates – Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes

Implants for surgery – Calcium phosphates – Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes

ISO 13179-1:2021

Implants for surgery – Plasma-sprayed unalloyed titanium coatings on metallic surgical implants – Part 1: General requirements

Implants for surgery – Plasma-sprayed unalloyed titanium coatings on metallic surgical implants – Part 1: General requirements

ISO 13314:2011

Mechanical testing of metals — Ductility testing — Compression test for porous and cellular metals

Mechanical testing of metals — Ductility testing — Compression test for porous and cellular metals

ISO 13356:2015

Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

ISO 13402:1995

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure

Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 13779-2:2018

Implants for surgery – Hydroxyapatite – Part 2: Thermally sprayed coatings of hydroxyapatite

Implants for surgery – Hydroxyapatite – Part 2: Thermally sprayed coatings of hydroxyapatite

ISO 13779-4:2018

Implants for surgery – Hydroxyapatite – Part 4: Determination of coating adhesion strength

Implants for surgery – Hydroxyapatite – Part 4: Determination of coating adhesion strength

ISO 13926-1:2004

Pen systems – Part 1: Glass cylinders for pen-injectors for medical use

Pen systems – Part 1: Glass cylinders for pen-injectors for medical use

ISO 14242-1:2014

Implants for surgery – Wear of total hip-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

Implants for surgery – Wear of total hip-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

ISO 14242-1:2014/Amd 1:2018

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 – Amendment 1

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 – Amendment 1

ISO 14242-2:2016

Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement

Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement

ISO 14242-4:2018

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

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

ISO 14243-1:2009/Amd 1:2020

Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test

Implants for surgery – Wear of total knee-joint prostheses – Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test

ISO 14243-2:2016

Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement

Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement

ISO 14243-3:2014/Amd 1:2020

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

Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test

ISO 14243-5:2019

Implants for surgery – Wear of total knee prostheses – Part 5: Durability performance of the patellofemoral joint

Implants for surgery – Wear of total knee prostheses – Part 5: Durability performance of the patellofemoral joint

ISO 14607:2018

Non-active surgical implants — Mammary implants — Particular requirements

Non-active surgical implants — Mammary implants — Particular requirements

ISO 14705:2016

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for hardness of monolithic ceramics at room temperature

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for hardness of monolithic ceramics at room temperature

ISO 14801:2016

Dentistry – Implants – Dynamic loading test for endosseous dental implants

Dentistry – Implants – Dynamic loading test for endosseous dental implants

ISO 14879-1:2020

Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays

Implants for surgery – Total knee-joint prostheses – Part 1: Determination of endurance properties of knee tibial trays

ISO 15142-1:2003

Implants for surgery – Metal intramedullary nailing systems – Part 1: Intramedullary nails

Implants for surgery – Metal intramedullary nailing systems – Part 1: Intramedullary nails

ISO 15142-2:2003

Implants for surgery – Metal intramedullary nailing systems – Part 2: Locking components

Implants for surgery – Metal intramedullary nailing systems – Part 2: Locking components

ISO 15142-3:2003

Implants for surgery – Metal intramedullary nailing systems – Part 3: Connection devices and reamer diameter measurements

Implants for surgery – Metal intramedullary nailing systems – Part 3: Connection devices and reamer diameter measurements

ISO 15676:2016

Cardiovascular implants and artificial organs – Requirements for single- use tubing packs for cardiopulmonary by pass and extracorporeal membrane oxygenation (ECMO)

Cardiovascular implants and artificial organs – Requirements for single- use tubing packs for cardiopulmonary by pass and extracorporeal membrane oxygenation (ECMO)

ISO 15912:2016

Dentistry – Refractory investment and die material

Dentistry – Refractory investment and die material

ISO 16061:2021

Instruments for use in association with non-active surgical implants — General requirements – 7.2 Pre-clinical evaluation

Instruments for use in association with non-active surgical implants — General requirements – 7.2 Pre-clinical evaluation

ISO 16402:2008

Implants for surgery – Acrylic resin cement – Flexural fatigue testing of acrylic resin cements used in orthopaedics

Implants for surgery – Acrylic resin cement – Flexural fatigue testing of acrylic resin cements used in orthopaedics

ISO 16429:2004

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

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

ISO 17853:2011

Wear of implant materials – Polymer and metal wear particles – Isolation and characterization

Wear of implant materials – Polymer and metal wear particles – Isolation and characterization

ISO 18192-1:2011

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test

ISO 18192-1:2011/Amd 1:2018

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 – Amendment 1

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test – Amendment 1

ISO 18192-2:2010

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 2: Nucleus replacements

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 2: Nucleus replacements

ISO 18192-3:2017

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions

Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions

ISO 18754:2013

Fine ceramics (advanced ceramics, advanced technical ceramics) – Determination of density and apparent porosity

Fine ceramics (advanced ceramics, advanced technical ceramics) – Determination of density and apparent porosity

ISO 19213:2017

Implants for surgery – Test methods of material for use as a cortical bone model

Implants for surgery – Test methods of material for use as a cortical bone model

ISO 20160:2006

Implants for surgery – Metallic materials – Classification of microstructures for alpha+beta titanium alloy bars

Implants for surgery – Metallic materials – Classification of microstructures for alpha+beta titanium alloy bars

ISO 21534:2007

Non-active surgical implants – Joint replacement implants – Particular requirements

Non-active surgical implants – Joint replacement implants – Particular requirements

ISO 21535:2007

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants

ISO 21535:2007/Amd 1:2016

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants

ISO 21536:2007

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

ISO 21536:2007/Amd 1:2014

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

ISO 22214:2006

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for cyclic bending fatigue of monolithic ceramics at room temperature

Fine ceramics (advanced ceramics, advanced technical ceramics) – Test method for cyclic bending fatigue of monolithic ceramics at room temperature

ISO 22622:2019

Implants for surgery — Wear of total ankle-joint prostheses — Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test

Implants for surgery — Wear of total ankle-joint prostheses — Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test

ISO 22675:2016

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods

Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods

ISO 23089-2:2021

Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices

Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements — Part 2: Spinal intervertebral body fusion devices

ISO 25539-1:2017

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

ISO 25539-2:2020

Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

Cardiovascular implants – Endovascular devices – Part 2: Vascular stents

ISO 29022:2013

Dentistry — Adhesion — Notched-edge shear bond strength test

Dentistry — Adhesion — Notched-edge shear bond strength test

ISO 37:2017

Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties

Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties

ISO 4967:2013

Steel – Determination of content of non-metallic inclusions – Micrographic method using standard diagrams

Steel – Determination of content of non-metallic inclusions – Micrographic method using standard diagrams

ISO 5832-2:2018

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

ISO 5832-3:2021

Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

ISO 5833:2002

Implants for surgery – Acrylic resin cements

Implants for surgery – Acrylic resin cements

ISO 5834-2:2019

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

ISO 5834-3:2019

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 3: Accelerated ageing methods

Implants for surgery – Ultra-high-molecular-weight polyethylene – Part 3: Accelerated ageing methods

ISO 5838-1:2013

Implants for surgery – Skeletal pins and wires – Part 1: Material and mechanical requirements

Implants for surgery – Skeletal pins and wires – Part 1: Material and mechanical requirements

ISO 5838-2:1991

Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions

Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – Dimensions

ISO 5838-3:1993

Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires

Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires

ISO 643:2012

Steels – Micrographic determination of the apparent grain size

Steels – Micrographic determination of the apparent grain size

ISO 6474-1:2019

Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina

Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high purity alumina

ISO 6474-2:2019

Implants for surgery – Ceramic materials – Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

Implants for surgery – Ceramic materials – Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

ISO 6475:1989

Implants for surgery – Metal bone screws with asymmetrical thread and spherical under-surface – Mechanical requirements and test methods

Implants for surgery – Metal bone screws with asymmetrical thread and spherical under-surface – Mechanical requirements and test methods

ISO 6872:2015

Dentistry – Ceramic materials

Dentistry – Ceramic materials

ISO 6892-1:2016

Metallic materials – Tensile testing – Part 1: Method of test at room temperature

Metallic materials – Tensile testing – Part 1: Method of test at room temperature

ISO 7198:2016

Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches

Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches

ISO 7206-1:2008

Implants for surgery – Partial and total hip joint prostheses – Part 1: Classification and designation of dimensions

Implants for surgery – Partial and total hip joint prostheses – Part 1: Classification and designation of dimensions

ISO 7206-10:2018/Amd 1:2021

Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads

Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads

ISO 7206-10:2018/Amd 1:2021

Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads

Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads

ISO 7206-12:2016

Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells

Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells

ISO 7206-13:2016

Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components

Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components

ISO 7206-13:2016/Amd1:2022

Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components – Amendment 1

Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components – Amendment 1

ISO 7206-2:2011

Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

ISO 7206-2:2011/Amd 1:2016

Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces made of metallic, ceramic and plastics materials

ISO 7206-4:2010

Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components

Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components

ISO 7206-6:2013

Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

ISO 7207-1:2007

Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification, definitions and designation of dimensions

Implants for surgery – Components for partial and total knee joint prostheses – Part 1: Classification, definitions and designation of dimensions

ISO 7207-2:2020/Amd 2:2020

Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials

Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials

ISO 7438:2020

Metallic materials – Bend test

Metallic materials – Bend test

ISO 7864:2016

Sterile hypodermic needles for single use — Requirements and test methods

Sterile hypodermic needles for single use — Requirements and test methods

ISO 80369-20: 2015

Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods

Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods

ISO 8827:1988

Implants for surgery – Staples with parallel legs for orthopaedic use – General requirements

Implants for surgery – Staples with parallel legs for orthopaedic use – General requirements

ISO 9585:1990

Implants for surgery – Determination of bending strength and stiffness of bone plates

Implants for surgery – Determination of bending strength and stiffness of bone plates

ISO 9626:2016

Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

ISO/TR 18130:2016

Dentistry – Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants

Dentistry – Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants

ISO/TS 13498:2011

Dentistry – Torsion test of implant body/connecting part joints of endosseous dental implant systems

Dentistry – Torsion test of implant body/connecting part joints of endosseous dental implant systems

PI-11 : 2021-11

Druckversuch statisch/dynamisch Pfanneninserts

Druckversuch statisch/dynamisch Pfanneninserts

PI-14 : 2021-11

Compression Test Hip Ball static/dynamic

Compression Test Hip Ball static/dynamic

PI-17 : 2018-10

Determination of Total Knee Implant Contact Pressure

Determination of Total Knee Implant Contact Pressure

PI-19 : 2018-10

Gliding Nail Fatigue Test

Gliding Nail Fatigue Test

PI-27 : 2014-11

Pen Injector 60 IU Stop

Pen Injector 60 IU Stop

PI-28 : 2014-11

Pen Injector 300 IU Stop

Pen Injector 300 IU Stop

PI-29 : 2014-11

Pen Injector Fluid Solvent Exposure

Pen Injector Fluid Solvent Exposure

PI-3: 2017-01

Luxationsversuch 2 (LUX2)

Luxationsversuch 2 (LUX2)

PI-30 : 2014-11

Pen Injector Dose accuracy different dose pattern

Pen Injector Dose accuracy different dose pattern

PI-31 : 2014-11

Pen Injector Drop Test Resistance with Increased Demands

Pen Injector Drop Test Resistance with Increased Demands

PI-32 : 2014-11

Pen Injector Cap Removal Force Test

Pen Injector Cap Removal Force Test

PI-33 : 2014-11

Pen Injector Needle Cover Interference

Pen Injector Needle Cover Interference

PI-35 : 2014-11

Pen Injector Dispense Force Test

Pen Injector Dispense Force Test

PI-36 : 2014-11

Pen Injector Dialing torque to set a dose

Pen Injector Dialing torque to set a dose

PI-37 : 2014-11

Pen Injector Dial Stop Torque 0 I.U.

Pen Injector Dial Stop Torque 0 I.U.

PI-38 : 2014-11

Pen Injector Dose number character height Dose Window Distortion

Pen Injector Dose number character height Dose Window Distortion

PI-39 : 2014-11

Pen Injector Dose accuracy after dial stop break torque

Pen Injector Dose accuracy after dial stop break torque

PI-40 : 2014-11

Pen Injector Disassembly Force Test

Pen Injector Disassembly Force Test

PI-41 : 2014-11

Pen Injector Dust Ingress

Pen Injector Dust Ingress

PI-52 : 2015-10

Expulsion test – spinal implants

Expulsion test – spinal implants

PI-53 : 2010-11

Fatigue testing of stemmed femoral TKA components

Fatigue testing of stemmed femoral TKA components

PI-54 : 2010-11

Mechanical Test – VBR spinal implants

Mechanical Test – VBR spinal implants

PI-57 : 2013-10

DIN EN 12006-3 : 2009-08 – Nichtaktive chirurgische Implantate – Besondere Anforderungen an Herz- und Gefäßimplantate – Teil 3: Blutgefäßstents und Hohlvenenfilter

DIN EN 12006-3 : 2009-08 – Nichtaktive chirurgische Implantate – Besondere Anforderungen an Herz- und Gefäßimplantate – Teil 3: Blutgefäßstents und Hohlvenenfilter

PI-58 :2013-10

ISO 7206-8 – Endurance performance of stemmed femoral components with application of torsion

ISO 7206-8 – Endurance performance of stemmed femoral components with application of torsion

PI-60 : 2014-10

ISO 6474 (1994): Implants for surgery – Ceramic materials based on high purity alumina

ISO 6474 (1994): Implants for surgery – Ceramic materials based on high purity alumina

PI-61 : 2021-12

Reverse Shoulder System Wear Test

Reverse Shoulder System Wear Test

PI-62 : 2014-10

Anatomic Shoulder System Wear Test

Anatomic Shoulder System Wear Test

PI-64 : 2016-04

Total hip joint prostheses – 3D Frictional torque

Total hip joint prostheses – 3D Frictional torque

PI-65: 2018-10

Determination of Total Ankle Replacement Contact Pressure

Determination of Total Ankle Replacement Contact Pressure

PI-68: 2019-04

(WK52025) Standard Test Method for Metallic Bone Plates Used in Small Bone Fracture Fixation

(WK52025) Standard Test Method for Metallic Bone Plates Used in Small Bone Fracture Fixation

PI-70: 2016-02

(WK28214) Practice for Accelerated Fretting Corrosion Testing of Modular Head and Neck Taper Junctions Used in Total Hip Replacement

(WK28214) Practice for Accelerated Fretting Corrosion Testing of Modular Head and Neck Taper Junctions Used in Total Hip Replacement

PI-71: 2016-02

(WK34814) Standard Guide for Collection and Evaluation of Metallic Products from Environmental Tests

(WK34814) Standard Guide for Collection and Evaluation of Metallic Products from Environmental Tests

PI-73: 2022-06

(ASTM F3210 – 22) Fatigue Testing of Total Knee Femoral Components under Closing Conditions

(ASTM F3210 – 22) Fatigue Testing of Total Knee Femoral Components under Closing Conditions

PI-76: 2016-02

(WK45142) Standard Practice for Mechanical Characterization of Spinous Process Plates

(WK45142) Standard Practice for Mechanical Characterization of Spinous Process Plates

PI-82: 2018-10

Determination of Screw Compression Force

Determination of Screw Compression Force

PI-85: 2022-01

(ISO 14607:2007 (Part 7.2.2.5.4 (Annex E.3)) Mammary Implants – Static and Fatigue Rupture Test

(ISO 14607:2007 (Part 7.2.2.5.4 (Annex E.3)) Mammary Implants – Static and Fatigue Rupture Test

PI-86: 2022-01

FEA ASTM F2582 worst-case determination impingement between polyethylene acetabular liner and metallic shell

FEA ASTM F2582 worst-case determination impingement between polyethylene acetabular liner and metallic shell

PI-87: 2022-01

FEA ISO 7206-6 femoral stem neck test

FEA ISO 7206-6 femoral stem neck test

PI-89: 2022-12

Implants for Surgery – Partial and total shoulder joint prosthesis Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres

Implants for Surgery – Partial and total shoulder joint prosthesis Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres

PI-90: 2022-12

Implants for Surgery – Partial and total shoulder joint prosthesis Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses

Implants for Surgery – Partial and total shoulder joint prosthesis Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses

PI-91: 2022-01

Fatigue testing of transfemoral fixations

Fatigue testing of transfemoral fixations

PI-92: 2022-12

Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants

Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants

PI-93: 2022-10

(ASTM F2477 – WK78802) Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

(ASTM F2477 – WK78802) Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents