| Standard | Title | Recognised by |
|---|
| ASTM F2391 | Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas | FDA |
| ASTM F2392 | Standard Test Method for Burst Strength of Surgical Sealants | FDA |
| ASTM F2393 | Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for | FDA |
| ASTM F2394 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery | FDA |
| ASTM F2407 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | FDA |
| ASTM F2423 | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses | FDA |
| ASTM F2450 | Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered | FDA |
| ASTM F2458 | Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants | FDA |
| ASTM F2459 | Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via | FDA |
| ASTM F2475 | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials | FDA |
| ASTM F2477 | Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascu | FDA |
| ASTM E2490 | Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by P | FDA |
| ASTM F2502 | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation I | FDA |
| ASTM F2503 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonan | FDA |
| ASTM F2504 | Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices | FDA |
| ASTM F2514 | Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Unifor | FDA |
| ASTM F2516 | Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials | FDA |
| ASTM E2524 | Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles | FDA |
| ASTM F2527 | Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tub | FDA |
| ASTM F2528 | Standard Test Methods for Enteral Feeding Devices with a Retention Balloon | FDA |
| ASTM F2529 | Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demin | FDA |
| ASTM E2535 | Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings | FDA |
| ASTM F2537 | Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromot | FDA |
| ASTM F2554 | Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems | FDA |
| ASTM F2565 | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene | FDA |
| ASTM E2578 | Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Si | FDA |
| ASTM F2579 | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Sur | FDA |
| ASTM F2580 | Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesi | FDA |
| ASTM F2582 | Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components | FDA |
| ASTM F2602 | Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclu | FDA |
| ASTM F2603 | Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds | FDA |
| ASTM F2605 | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromat | FDA |
| ASTM F2606 | Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems | FDA |
| ASTM F2624 | Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spina | FDA |
| ASTM F2625 | Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting P | FDA |
| ASTM F2633 | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical | FDA |
| ASTM F2638 | Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packag | FDA |
| ASTM F2665 | Standard Specification for Total Ankle Replacement Prosthesis | FDA |
| ASTM F2695 | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-To | FDA |
| ASTM F2706 | Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Cons | FDA |
| ASTM F2721 | Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects | FDA |
| ASTM F2722 | Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops | FDA |
| ASTM F2723 | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to D | FDA |
| ASTM F2724 | Standard Test Method for Evaluating Mobile Bearing Knee Dislocation | FDA |
| ASTM F2739 | Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffold | FDA |
| ASTM F2743 | Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Elut | FDA |
| ASTM F2759 | Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in O | FDA |
| ASTM F2777 | Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under | FDA |
| ASTM F2778 | Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Pol | FDA |
| ASTM F2789 | Standard Guide for Mechanical and Functional Characterization of Nucleus Devices | FDA |
| ASTM F2791 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions | FDA |
| ASTM F2819 | Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used fo | FDA |
| ASTM F2820 | Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applicatio | FDA |
| ASTM F2825 | Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery | FDA |
| ASTM E2834 | Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by N | FDA |
| ASTM F2847 | Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use | FDA |
| ASTM F2848 | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns | FDA |
| ASTM E2859 | Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy | FDA |
| ASTM E2865 | Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biolo | FDA |
| ASTM F2885 | Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Su | FDA |
| ASTM F2886 | Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for S | FDA |
| ASTM F2887 | Standard Specification for Total Elbow Prostheses | FDA |
| ASTM F2888 | Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Asses | FDA |
| ASTM F2895 | Standard Practice for Digital Radiography of Cast Metallic Implants | FDA |
| ASTM F2901 | Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices | FDA |
| ASTM F2902 | Standard Guide for Assessment of Absorbable Polymeric Implants | FDA |
| ASTM F2914 | Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices | FDA |
| ASTM F2924 | Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed | FDA |
| ASTM F2942 | Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents | FDA |
| ASTM F2943 | Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in | FDA |
| ASTM F2944 | Standard Practice for Automated Colony Forming Unit (CFU) Assays - Image Acquisition and Analysi | FDA |
| ASTM E2948 | Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire | FDA |
| ASTM F2971 | Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing | FDA |
| ASTM F2977 | Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants | FDA |
| ASTM F2978 | Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal | FDA |
| ASTM F2979 | Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on | FDA |
| ASTM F2989 | Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Imp | FDA |
| ASTM F2996 | Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femo | FDA |
| ASTM F3001 | Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low | FDA |
| ASTM F3004 | Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound | FDA |
| ASTM F3018 | Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfa | FDA |
| ASTM E3025 | Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in | FDA |
| ASTM F3036 | Standard Guide for Testing Absorbable Stents | FDA |
| ASTM F3039 | Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by | FDA |
| ASTM F3044 | Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants | FDA |
| ASTM F3047M | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations | FDA |
| ASTM F3067 | Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents | FDA |
| ASTM D3078 | Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission | FDA |
| ASTM F3087 | Standard Specification for Acrylic Molding Resins for Medical Implant Applications | FDA |
| ASTM F3090 | Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement | FDA |
| ASTM F3107 | Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of | FDA |
| ASTM F3109 | Standard Test Method for Verification of Multi-Axis Force Measuring Platforms | FDA |
| ASTM F3122 | Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufac | FDA |
| ASTM F3127 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices | FDA |
| ASTM F3129 | Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint | FDA |
| ASTM F3140 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar K | FDA |
| ASTM F3141 | Standard Guide for Total Knee Replacement Loading Profiles | FDA |
| ASTM F3143 | Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacem | FDA |
| ASTM F3160 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical I | FDA |
| ASTM F3161 | Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femora | FDA |
| ASTM F3172 | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular De | FDA |
| ASTM F3186 | Standard Specification for Adult Portable Bed Rails and Related Products | FDA |
| ASTM F3206 | Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies | FDA |
| ASTM F3207 | Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Mod | FDA |
| ASTM F3208 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical | FDA |
| ASTM F3211 | Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices | FDA |
| ASTM F3212 | Standard Test Method for Coring Testing of Huber Needles | FDA |
| ASTM F3224 | Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonan | FDA |
| ASTM E3247 | Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Ligh | FDA |
| ASTM F3259 | Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds | FDA |
| ASTM F3260 | Standard Test Method for Determining the Flexural Stiffness of Medical Textiles | FDA |
| ASTM F3275 | Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clea | FDA |
| ASTM E3275 | Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiolog | FDA |
| ASTM F3276 | Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to | FDA |
| ASTM F3292 | Standard Practice for Inspection of Spinal Implants Undergoing Testing | FDA |
| ASTM F3293 | Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable | FDA |
| ASTM F3295 | Standard Guide for Impingement Testing of Total Disc Prostheses | FDA |
| ASTM F3302 | Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Tita | FDA |
| ASTM F3306 | Standard Test Method for Ion Release Evaluation of Medical Implants | FDA |
| ASTM F3320 | Standard Guide forCoating Characterization of Drug Coated Balloons | FDA |
| ASTM F3321 | Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods fo | FDA |
| ASTM F3333 | Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Pol | FDA |
| ASTM F3334 | Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Co | FDA |
| ASTM F3335 | Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices F | FDA |
| ASTM F3357 | Standard Guide for Designing Reusable Medical Devices for Cleanability | FDA |
| ASTM F3374 | Standard Guide for Active Fixation Durability of Endovascular Prostheses | FDA |
| ASTM F3384 | Standard Specification for Polydioxanone Polymer Resins for Surgical Implants | FDA |
| ASTM F3434 | Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/P | FDA |
| ASTM F3437 | Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation | FDA |
| ASTM F3446 | Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants | FDA |
| ASTM F3456 | Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications f | FDA |
| ASTM D3492 | Standard Specification for Rubber Contraceptives (Male Condoms) | FDA |
| ASTM F3495 | Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components | FDA |
| ASTM F3502 | Standard Specification for Barrier Face Coverings | FDA |
| ASTM F3505 | Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance | FDA |
| ASTM F3574 | Standard Test Methods for Sacroiliac Joint Fusion Devices | FDA |
| ASTM D3577 | Standard Specification for Rubber Surgical Gloves | FDA |
| ASTM D3578 | Standard Specification for Rubber Examination Gloves | FDA |
| ASTM F3604 | Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical | FDA |
| ASTM F3631 | Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion | FDA |
| ASTM F3690 | Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance | FDA |
| ASTM F3738 | Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under | FDA |
| ASTM F3766 | Standard Guide for Content and Format of Test Report Summaries for Medical and Surgical Material | FDA |
| ASTM D3772 | Standard Specification for Industrial Rubber Finger Cots | FDA |
| ASTM D4169 | Standard Practice for Performance Testing of Shipping Containers and Systems | FDA |
| ASTM D4332 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing | FDA |
| ASTM D5151 | Standard Test Method for Detection of Holes in Medical Gloves | FDA |
| ASTM D5250 | Standard Specification for Poly(vinyl chloride) Gloves for Medical Application | FDA |
| ASTM D5712 | Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Nat | FDA |
| ASTM D6124 | Standard Test Method for Residual Powder on Medical Gloves | FDA |
| ASTM D6319 | Standard Specification for Nitrile Examination Gloves for Medical Application | FDA |
| ASTM D6355 | Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves | FDA |
| ASTM D6499 | Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber | FDA |
| ASTM D6977 | Standard Specification for Polychloroprene Examination Gloves for Medical Application | FDA |
| ASTM D6978 | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy D | FDA |
| ASTM D7103 | Standard Guide for Assessment of Medical Gloves | FDA |
| ASTM D7160 | Standard Practice for Determination of Expiration Dating for Medical Gloves | FDA |
| ASTM D7386 | Standard Practice for Performance Testing of Packages for Single Delivery Systems | FDA |
| ASTM D7661 | Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber La | FDA |
| ASTM D7866 | Standard Specification for Radiation Attenuating Protective Gloves | FDA |
| ASTM D7907 | Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Exami | FDA |
| ASTM F1408-20a | Standard Practice for Subcutaneous Screening Test for Implant Materials | FDA |
| ASTM F2028-25a | Standard Test Methods for Dynamic Evaluation of Glenoid Loosening | FDA |
| ASTM F2129-19a | Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determin | FDA |
| ASTM F3268-18a | Standard Guide for in vitro Degradation Testing of Absorbable Metals | FDA |
| ASTM F3301-18a | Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Therm | FDA |
| ASTM F3502-22a | Standard Specification for Barrier Face Coverings | FDA |
| ASTM F88/F88M-23 | Standard Test Method for Seal Strength of Flexible Barrier Materials | FDA |
| ASTM F1378-18e1 | Standard Specification for Shoulder Prostheses | FDA |
| ASTM F2182-19e2 | Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Impla | FDA |
| ASTM F3210-22e1 | Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditio | FDA |
| ASTM F3287-17e1 | Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method | FDA |
| ASTM D6976-13R18 | Standard Specification for Rubber Contraceptives - Vaginal Diaphragms | FDA |
| ASTM F1140/F1140M-13 | Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages | FDA |
| ASTM F1670/F1670M-17a | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by S | FDA |
| ASTM F1670/F1670M-24a | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by S | FDA |
| ASTM F1671/F1671M-22 | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by B | FDA |
| ASTM F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Hor | FDA |
| ASTM F1862/F1862M-24 | Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Hor | FDA |
| ASTM F1886/F1886M-16 | Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspect | FDA |
| ASTM F1926/F1926M-14 | Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules | FDA |
| ASTM F2054/F2054M-13 | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurizati | FDA |
| ASTM F2082/F2082M-16 | Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Me | FDA |
| ASTM F2082/F2082M-23 | Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and F | FDA |
| ASTM F2217/F2217M-13 | Standard Practice for Coating/Adhesive Weight Determination | FDA |
| ASTM F2252/F2252M-13 | Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using T | FDA |
| ASTM F2407/F2407M-23a | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | FDA |
| ASTM F2754/F2754M-21 | Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wir | FDA |
| ASTM F3091/F3091M-14 | Standard Specification for Powder Bed Fusion of Plastic Materials | FDA |
| ASTM F3352/F3352M-23a | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities | FDA |
| ASTM F3352/F3352M-23b | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities | FDA |
| ASTM F3395/F3395M-19 | Standard Specification for Neurosurgical Head Holder Devices | FDA |