| Standard | Title | Recognised by |
|---|
| ASTM G5 | Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements | FDA |
| ASTM F17 | Standard Terminology Relating to Flexible Barrier Packaging | FDA |
| ASTM F67 | Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UN | FDA |
| ASTM F75 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for | FDA |
| ASTM F86 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants | FDA |
| ASTM F90 | Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical I | FDA |
| ASTM F116 | Standard Specification for Medical Screwdriver Bits | FDA |
| ASTM F136 | Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) A | FDA |
| ASTM F138 | Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wir | FDA |
| ASTM F139 | Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet an | FDA |
| ASTM G175 | Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regul | FDA |
| ASTM F366 | Standard Specification for Fixation Pins and Wires | FDA |
| ASTM F382 | Standard Specification and Test Method for Metallic Bone Plates | FDA |
| ASTM F384 | Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Device | FDA |
| ASTM D412 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension | FDA |
| ASTM F451 | Standard Specification for Acrylic Bone Cement | FDA |
| ASTM F543 | Standard Specification and Test Methods for Metallic Medical Bone Screws | FDA |
| ASTM F560 | Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS | FDA |
| ASTM F561 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Flui | FDA |
| ASTM F562 | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical | FDA |
| ASTM F564 | Standard Specification and Test Methods for Metallic Bone Staples | FDA |
| ASTM F565 | Standard Practice for Care and Handling of Orthopedic Implants and Instruments | FDA |
| ASTM F601 | Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants | FDA |
| ASTM F603 | Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application | FDA |
| ASTM F619 | Standard Practice for Extraction of Materials Used in Medical Devices | FDA |
| ASTM F620 | Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta | FDA |
| ASTM F621 | Standard Specification for Stainless Steel Forgings for Surgical Implants | FDA |
| ASTM F623 | Standard Performance Specification for Foley Catheter | FDA |
| ASTM F624 | Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical App | FDA |
| ASTM F629 | Standard Practice for Radiography of Cast Metallic Surgical Implants | FDA |
| ASTM D638 | Standard Test Method for Tensile Properties of Plastics | FDA |
| ASTM F640 | Standard Test Methods for Determining Radiopacity for Medical Use | FDA |
| ASTM E647 | Standard Test Method for Measurement of Fatigue Crack Growth Rates | FDA |
| ASTM F647 | Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical A | FDA |
| ASTM F648 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form f | FDA |
| ASTM E667 | Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers | FDA |
| ASTM F688 | Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, a | FDA |
| ASTM F702 | Standard Specification for Polysulfone Resin for Medical Applications | FDA |
| ASTM F703 | Standard Specification for Implantable Breast Prostheses | FDA |
| ASTM F719 | Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation | FDA |
| ASTM F720 | Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test | FDA |
| ASTM F732 | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses | FDA |
| ASTM F739 | Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials U | FDA |
| ASTM F746 | Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials | FDA |
| ASTM F748 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices | FDA |
| ASTM F749 | Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit | FDA |
| ASTM F750 | Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Inject | FDA |
| ASTM F754 | Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shape | FDA |
| ASTM F755 | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants | FDA |
| ASTM F756 | Standard Practice for Assessment of Hemolytic Properties of Materials | FDA |
| ASTM F763 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials | FDA |
| ASTM D790 | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electr | FDA |
| ASTM D792 | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displac | FDA |
| ASTM F799 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants | FDA |
| ASTM F813 | Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices | FDA |
| ASTM E825 | Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Deter | FDA |
| ASTM F881 | Standard Specification for Silicone Elastomer Facial Implants | FDA |
| ASTM D882 | Standard Test Methods for Tensile Properties of Thin Plastic Sheeting | FDA |
| ASTM F895 | Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity | FDA |
| ASTM F897 | Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws | FDA |
| ASTM F899 | Standard Specification for Wrought Stainless Steels for Surgical Instruments | FDA |
| ASTM D903 | Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds | FDA |
| ASTM F921 | Standard Terminology Relating to Hemostatic Forceps | FDA |
| ASTM F961 | Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical | FDA |
| ASTM F981 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Ma | FDA |
| ASTM F983 | Standard Practice for Permanent Marking of Orthopaedic Implant Components | FDA |
| ASTM F997 | Standard Specification for Polycarbonate Resin for Medical Applications | FDA |
| ASTM F1044 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings | FDA |
| ASTM F1058 | Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, S | FDA |
| ASTM E1061 | Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers | FDA |
| ASTM F1078 | Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades | FDA |
| ASTM F1088 | Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation | FDA |
| ASTM F1089 | Standard Test Method for Corrosion of Surgical Instruments | FDA |
| ASTM F1091 | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation | FDA |
| ASTM E1104 | Standard Specification for Clinical Thermometer Probe Covers and Sheaths | FDA |
| ASTM F1108 | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UN | FDA |
| ASTM E1112 | Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temp | FDA |
| ASTM F1147 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings | FDA |
| ASTM F1160 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Med | FDA |
| ASTM F1169 | Standard Consumer Safety Specification for Full-Size Baby Cribs | FDA |
| ASTM F1185 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants | FDA |
| ASTM F1223 | Standard Test Method for Determination of Total Knee Replacement Constraint | FDA |
| ASTM E1262 | Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphorib | FDA |
| ASTM F1264 | Standard Specification and Test Methods for Intramedullary Fixation Devices | FDA |
| ASTM F1295 | Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Appli | FDA |
| ASTM F1314 | Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molyb | FDA |
| ASTM F1350 | Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical | FDA |
| ASTM F1357 | Standard Specification for Articulating Total Wrist Implants | FDA |
| ASTM F1377 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, | FDA |
| ASTM D1415 | Standard Test Method for Rubber Property - International Hardness | FDA |
| ASTM F1439 | Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Mat | FDA |
| ASTM F1441 | Standard Specification for Soft-Tissue Expander Devices | FDA |
| ASTM F1472 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Appli | FDA |
| ASTM D1505 | Standard Test Method for Density of Plastics by the Density-Gradient Technique | FDA |
| ASTM F1537 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (U | FDA |
| ASTM F1541 | Standard Specification and Test Methods for External Skeletal Fixation Devices | FDA |
| ASTM F1580 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coating | FDA |
| ASTM F1581 | Standard Specification for Composition of Anorganic Bone for Surgical Implants | FDA |
| ASTM F1582 | Standard Terminology Relating to Spinal Implants | FDA |
| ASTM F1586 | Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 M | FDA |
| ASTM F1608 | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Metho | FDA |
| ASTM F1609 | Standard Specification for Calcium Phosphate Coatings for Implantable Materials | FDA |
| ASTM F1611 | Standard Specification for Intramedullary Reamers | FDA |
| ASTM F1635 | Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resin | FDA |
| ASTM F1713 | Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant A | FDA |
| ASTM F1714 | Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices | FDA |
| ASTM F1717 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | FDA |
| ASTM F1781 | Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants | FDA |
| ASTM F1798 | Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechani | FDA |
| ASTM F1800 | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint | FDA |
| ASTM F1801 | Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials | FDA |
| ASTM F1813 | Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Sur | FDA |
| ASTM F1814 | Standard Guide for Evaluating Modular Hip and Knee Joint Components | FDA |
| ASTM F1820 | Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices | FDA |
| ASTM F1828 | Standard Specification for Ureteral Stents | FDA |
| ASTM F1829 | Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear | FDA |
| ASTM F1830 | Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hem | FDA |
| ASTM F1839 | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Or | FDA |
| ASTM F1840 | Standard Terminology for Surgical Suture Needles | FDA |
| ASTM F1841 | Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps | FDA |
| ASTM F1854 | Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants | FDA |
| ASTM F1855 | Standard Specification for Polyoxymethylene (Acetal) for Medical Applications | FDA |
| ASTM F1874 | Standard Test Method for Bend Testing of Needles Used in Surgical Sutures | FDA |
| ASTM F1875 | Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head | FDA |
| ASTM F1877 | Standard Practice for Characterization of Particles | FDA |
| ASTM D1894 | Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheetin | FDA |
| ASTM F1903 | Standard Practice for Testing for Cellular Responses to Particles in vitro | FDA |
| ASTM F1904 | Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Deg | FDA |
| ASTM F1925 | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgi | FDA |
| ASTM F1929 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | FDA |
| ASTM E1965 | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Tempe | FDA |
| ASTM F1978 | Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Usi | FDA |
| ASTM F1980 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | FDA |
| ASTM F1983 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Impla | FDA |
| ASTM F1984 | Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials | FDA |
| ASTM F2003 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma | FDA |
| ASTM F2004 | Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysi | FDA |
| ASTM F2005 | Standard Terminology for Nickel-Titanium Shape Memory Alloys | FDA |
| ASTM F2009 | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular | FDA |
| ASTM F2024 | Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxy | FDA |
| ASTM F2026 | Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Application | FDA |
| ASTM F2027 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineer | FDA |
| ASTM F2028 | Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation | FDA |
| ASTM F2033 | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Ma | FDA |
| ASTM F2038 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Fo | FDA |
| ASTM F2042 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - | FDA |
| ASTM F2051 | Standard Specification for Implantable Saline Filled Breast Prosthesis | FDA |
| ASTM F2052 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devic | FDA |
| ASTM F2062 | Standard Specification for Square Drive Interconnections on Surgical Instruments | FDA |
| ASTM F2063 | Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and S | FDA |
| ASTM F2064 | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for | FDA |
| ASTM F2066 | Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Application | FDA |
| ASTM F2077 | Test Methods for Intervertebral Body Fusion Devices | FDA |
| ASTM F2079 | Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents | FDA |
| ASTM F2081 | Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular S | FDA |
| ASTM F2095 | Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restra | FDA |
| ASTM F2096 | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble T | FDA |
| ASTM F2097 | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products | FDA |
| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical Face Masks | FDA |
| ASTM F2101 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Ma | FDA |
| ASTM F2102 | Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended | FDA |
| ASTM F2103 | Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended | FDA |
| ASTM F2118 | Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone | FDA |
| ASTM F2119 | Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | FDA |
| ASTM F2129 | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determin | FDA |
| ASTM F2132 | Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Med | FDA |
| ASTM F2146 | Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surg | FDA |
| ASTM F2148 | Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymp | FDA |
| ASTM F2150 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Me | FDA |
| ASTM F2172 | Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers | FDA |
| ASTM F2180 | Standard Specification for Metallic Implantable Strands and Cables | FDA |
| ASTM F2181 | Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants | FDA |
| ASTM F2193 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spi | FDA |
| ASTM F2203 | Standard Test Method for Linear Measurement Using Precision Steel Rule | FDA |
| ASTM F2211 | Standard Classification for Tissue Engineered Medical Products (TEMPs) | FDA |
| ASTM F2212 | Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implan | FDA |
| ASTM F2213 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Ma | FDA |
| ASTM F2214 | Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High | FDA |
| ASTM F2224 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Imp | FDA |
| ASTM F2227 | Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Tr | FDA |
| ASTM F2228 | Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorpora | FDA |
| ASTM F2229 | Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low | FDA |
| ASTM F2250 | Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible | FDA |
| ASTM F2251 | Standard Test Method for Thickness Measurement of Flexible Packaging Material | FDA |
| ASTM F2255 | Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading | FDA |
| ASTM F2256 | Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading | FDA |
| ASTM F2257 | Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenu | FDA |
| ASTM F2258 | Standard Test Method for Strength Properties of Tissue Adhesives in Tension | FDA |
| ASTM F2260 | Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear | FDA |
| ASTM F2267 | Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device | FDA |
| ASTM F2312 | Standard Terminology Relating to Tissue Engineered Medical Products | FDA |
| ASTM F2313 | Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Im | FDA |
| ASTM F2315 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels | FDA |
| ASTM F2338 | Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method | FDA |
| ASTM F2345 | Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral He | FDA |
| ASTM F2346 | Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs | FDA |
| ASTM F2347 | Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for | FDA |
| ASTM F2381 | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weig | FDA |
| ASTM F2382 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on | FDA |
| ASTM F2385 | Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total H | FDA |