List of Medical Device and Implant Standards

• ASTM D6319 – Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM F138 – Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F2063 – Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
• ASTM F997 – Standard Specification for Polycarbonate Resin for Medical Applications
• ASTM F981 – Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
• ASTM F982 – Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
• ASTM F983 – Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F961 – Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
• ASTM F921 – Standard Terminology Relating to Hemostatic Forceps
• ASTM F881 – Standard Specification for Silicone Elastomer Facial Implants
• ASTM F882 – Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
• ASTM F895 – Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
• ASTM F897 – Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
• ASTM F899 – Standard Specification for Wrought Stainless Steels for Surgical Instruments
• ASTM F90 – Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
• ASTM F86 – Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• ASTM F813 – Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
• ASTM F787 – Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)
• ASTM F799 – Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• ASTM F75 – Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F754 – Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
• ASTM F755 – Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
• ASTM F756 – Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F763 – Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
• ASTM F750 – Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
• ASTM F732 – Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• ASTM F745 – Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
• ASTM F746 – Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• ASTM F748 – Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F749 – Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
• ASTM F700 – Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
• ASTM F701 – Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017)
• ASTM F702 – Standard Specification for Polysulfone Resin for Medical Applications
• ASTM F703 – Standard Specification for Implantable Breast Prostheses
• ASTM F719 – Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
• ASTM F720 – Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
• ASTM F67 – Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F688 – Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
• ASTM F648 – Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• ASTM F665 – Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
• ASTM F629 – Standard Practice for Radiography of Cast Metallic Surgical Implants
• ASTM F639 – Standard Specification for Polyethylene Plastics for Medical Applications
• ASTM F640 – Standard Test Methods for Determining Radiopacity for Medical Use
• ASTM F641 – Standard Specification for Implantable Epoxy Electronic Encapsulants
• ASTM F647 – Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
• ASTM F601 – Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• ASTM F602 – Standard Criteria for Implantable Thermoset Epoxy Plastics
• ASTM F603 – Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• ASTM F604 – Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
• ASTM F619 – Standard Practice for Extraction of Materials Used in Medical Devices
• ASTM F620 – Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• ASTM F621 – Standard Specification for Stainless Steel Forgings for Surgical Implants
• ASTM F622 – Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
• ASTM F623 – Standard Performance Specification for Foley Catheter
• ASTM F624 – Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
• ASTM F565 – Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F560 – Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
• ASTM F561 – Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• ASTM F562 – Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
• ASTM F563 – Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
• ASTM F564 – Standard Specification and Test Methods for Metallic Bone Staples
• ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws
• ASTM F544 – Reference Chart for Pictorial Cortical Bone Screw Classification (Withdrawn 1998)
• ASTM F451 – Standard Specification for Acrylic Bone Cement
• ASTM F452 – Standard Specification for Preformed Cranioplasty Plates
• ASTM F370 – Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
• ASTM F382 – Standard Specification and Test Method for Metallic Bone Plates
• ASTM F384 – Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• ASTM F3574 – Standard Test Methods for Sacroiliac Joint Fusion Devices
• ASTM F3602 – Standard Guide for Assessing the Compatibility of a Cleaning Brush Part with Different Substrates Used in the Construction of Medical Devices
• ASTM F366 – Standard Specification for Fixation Pins and Wires
• ASTM F367 – Specification for Holes and Slots for Inch Cortical Bone Screws (Withdrawn 1997)
• ASTM F3570 – Standard Terminology Relating to Microphysiological Systems
• ASTM F3487 – Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
• ASTM F3504 – Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
• ASTM F3505 – Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
• ASTM F3510 – Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• ASTM F3515 – Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications
• ASTM F3438 – Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3446 – Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
• ASTM F3448 – Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
• ASTM F3374 – Standard Guide for Active Fixation Durability of Endovascular Prostheses
• ASTM F3384 – Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
• ASTM F3395/F3395M – Standard Specification for Neurosurgical Head Holder Devices
• ASTM F3354 – Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
• ASTM F3357 – Standard Guide for Designing Reusable Medical Devices for Cleanability
• ASTM F3368 – Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
• ASTM F3369 – Standard Guide for Assessing the Skeletal Myoblast Phenotype
• ASTM F3333 – Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• ASTM F3334 – Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
• ASTM F3335 – Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
• ASTM F3336 – Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
• ASTM F3306 – Standard Test Method for Ion Release Evaluation of Medical Implants
• ASTM F3320 – Standard Guide for Coating Characterization of Drug Coated Balloons
• ASTM F3321 – Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3292 – Standard Practice for Inspection of Spinal Implants Undergoing Testing
• ASTM F3293 – Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
• ASTM F3294 – Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy
• ASTM F3295 – Standard Guide for Impingement Testing of Total Disc Prostheses
• ASTM F3268 – Standard Guide for in vitro Degradation Testing of Absorbable Metals

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