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List of Medical Device and Implant Standards

427 standards

American National Standards Institute Inc.

  • 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F982 – Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)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  • ASTM F882 – Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)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 F881 – Standard Specification for Silicone Elastomer Facial Implants

  • 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  • ASTM F787 – Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)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 F750 – Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse

  • 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 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 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 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 F624 – Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

  • 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 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 F565 – Standard Practice for Care and Handling of Orthopedic Implants and Instruments

  • ASTM F544 – Reference Chart for Pictorial Cortical Bone Screw Classification (Withdrawn 1998)

  • ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws

  • 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 F3570 – Standard Terminology Relating to Microphysiological Systems

  • 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 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 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 F3306 – Standard Test Method for Ion Release Evaluation of Medical Implants

  • 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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1375 - Demolition Materials (549) 1377 - Cartridge and Propellant Actuated Devices and Components (524) 4720 - Hose and Flexible Tubing (552) 4730 - Hose, Pipe, Tube, Lubrication, and Railing Fittings (1823) 5120 - Hand Tools, Nonedged, Nonpowered (1124) 5305 - Screws (781) 5306 - Bolts (996) 5310 - Nuts and Washers (864) 5330 - Packing and Gasket Materials (583) 5340 - Hardware, Commercial (953) 5905 - Resistor (753) 5910 - Capacitors (783) 5930 - Switches (1012) 5935 - Connectors, Electrical (4357) 5940 - Lugs, Terminals, and Terminal Strips (564) 5945 - Relays and Solenoids (733) 5950 - Coils and Transformers (856) 5960 - Electron Tubes and Associated Hardware (1630) 5961 - Semiconductor Devices and Associated Hardware (707) 6145 - Wire and Cable, Electrical (1629) 6240 - Electric Lamps (662) 6505 - Drugs and Biologicals (1343) 6515 - Medical and Surgical Instruments, Equipment, and Supplies (1907) 6520 - Dental Instruments, Equipment, and Supplies (790) 6530 - Hospital Furniture, Equipment, Utensils, and Supplies (745) 6610 - Flight Instruments (540) 6625 - Electrical and Electronic Properties Measuring and Testing Instruments (1241) 6640 - Laboratory Equipment and Supplies (1187) 6810 - Chemicals (1114) 8010 - Paints, Dopes, Varnishes, and Related Products (2046) 8030 - Preservative and Sealing Compounds (554) 8140 - Ammunition and Nuclear Ordnance Boxes, Packages and Special Containers (797) 8305 - Textile Fabrics (910) 8415 - Clothing, Special Purpose (660) 8455 - Badges and Insignia (3093) 8915 - Fruits and Vegetables (531) 9330 - Plastics Fabricated Materials (759) FACR (1647) ISDA (1776) ISDD (786) ISDF (1827) ISDN (581) MISC (1045) PACK (539) SESS (581)

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