Medical Implants products maybe tested according to many different Medical Implants Test Method and Standards including:
- ISO 7207 Implants for surgery Components for partial and total knee joint prostheses
- ISO 7206-13:2016 Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
- ISO 7206-10:2003 Part 10: Determination of resistance to static load of modular femoral heads
- ISO 7206-6:2013 Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
- ISO 7206-4:2010 Part 4: Determination of endurance properties and performance of stemmed femoral components
- ISO 7206 Implants for surgery Partial and total hip joint prostheses
- ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
- ISO 7198:2016 Cardiovascular implants and extracorporeal systems Vascular prostheses Tubular vascular grafts and vascular patches
- ISO 7197:2006 Neurosurgical implants Sterile
- single-use hydrocephalus shunts and components
- ISO 5841 Implants for surgery Cardiac pacemakers
- ISO 5840 Cardiovascular implants Cardiac valve prostheses
- ISO 5838 Implants for surgery Metallic skeletal pins and wires
- ISO 5834 Implants for surgery Ultra-high-molecular-weight polyethylene
- ISO 5833:2002 Implants for surgery Acrylic resin cements
- ISO 5832 Implants for surgery ? Metallic materials
- EN 45502-1 Active implantable medical devices - Part 1 General requirements for safety
- marking and information to be provided by the manufacturer
- ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
- ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
- ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- ASTM F451-16 - Standard Specification for Acrylic Bone Cement
- ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
- ASTM F601-18 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
- ASTM F640-12 - Standard Test Methods for Determining Radiopacity for Medical Use
- ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
- ASTM F746-04(2014) - Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
- ASTM F756-17 - Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F813-07(2012) - Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ASTM F838-15a - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
- ASTM F895-11(2016) - Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F897-02(2013) - Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
- ASTM F981-04(2016) - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
- ASTM F1027-86(2017) - Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
- ASTM F1044-05(2017)e1 - Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
- ASTM F1089-18 - Standard Test Method for Corrosion of Surgical Instruments
- ASTM F1147-05(2017)e1 - Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1223-14 - Standard Test Method for Determination of Total Knee Replacement Constraint
- ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
- ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
- ASTM F1635-16 - Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
- ASTM F1798-13 - Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM F1800-12 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
- ASTM F1801-97(2014) - Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
- ASTM F1814-15 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
- ASTM 1854-15 - Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
- ASTM F1874-98(2011) - Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
- ASTM F1903-10 - Standard Practice for Testing For Biological Responses to Particles In Vitro
- ASTM F1904-14 - Standard Practice for Testing the Biological Responses to Particles in vivo
- ASTM F1926/F1926M-14 - Standard Test Method for Dissolution Testing of Calcium Phosphate Granules
- Fabricated Forms
- and Coatings
- ASTM F1983-14 - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
- ASTM F1984-99(2018) - Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
- ASTM F2004-17 - Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
- ASTM F2024-10(2016) - Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
- ASTM F2025-06(2018) - Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
- ASTM F2064-17 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
- ASTM F2077-17 - Test Methods For Intervertebral Body Fusion Devices
- ASTM F2079-09(2017) - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
- ASTM F2118-14 - Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
- ASTM F2129-17b - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- ASTM F2131-02(2012) - Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line
- ASTM F2148-13 - Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
- ASTM F2149-16 - Standard Test Method for Automated Analyses of Cells the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
- ASTM F2150-13 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
- ASTM F2193-18a - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- ASTM F2255-05(2015) - Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
- ASTM F2256-05(2015) - Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
- ASTM F2260-03(2012)e1 - Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR)
- ASTM F2382-17e1 - Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) Spectroscopy
- ASTM F2392-04(2015) - Standard Test Method for Burst Strength of Surgical Sealants
- ASTM F2451-05(2010) - Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F2458-05(2015) - Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
- ASTM F2459-18 - Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
- ASTM F2477-07(2013) - Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
- ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- ASTM F2528-06(2014) - Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
- ASTM F2529-13 - Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
- ASTM F2625-10(2016) - Standard Test Method for Measurement of Enthalpy of Fusion
- Percent Crystallinity
- and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
- ASTM F2664-11 - Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
- ASTM F2721-09(2014) - Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F2778-09(2015) - Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
- ASTM F2808-17 - Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
- ASTM F2884-12 - Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
- ASTM F2888-13 - Standard Test Method for Platelet Leukocyte Count?An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
- ASTM F2901-13 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
- ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
- ASTM F2942-13 - Standard Guide for in vitro Axial
- Bending
- and Torsional Durability Testing of Vascular Stents
- ASTM F2944-12 - Standard Test Method for Automated Colony Forming Unit (CFU) Assays?Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
- ASTM F2977-13 - Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
- ASTM F2998-14 - Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells
- ASTM F3014-14 - Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
- ASTM F3036-13 - Standard Guide for Testing Absorbable Stents
- ASTM F3044-14 - Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
- ASTM F3088-14 - Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
- ASTM F3089-14 - Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
- ASTM F3106-14 - Standard Guide for in vitro Osteoblast Differentiation Assays
- ASTM F3107-14 - Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
- ASTM F3127-16 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
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