ASTM Medical Device Standards

Medical Device Standards

ASTM International has been at the forefront of developing standards that have shaped the medical device industry. Standards under the medical and surgical device category pertain mostly to cardiology, neurology, audiology, gastroenterology, and plastic surgery.

Over the years, ASTM has continued to expand its medical device standards portfolio, working closely with regulatory bodies, such as the U.S. Food and Drug Administration (FDA), to ensure that its standards align with the latest regulatory requirements.

ASTM Compass is your comprehensive online portal to the world of medical device standards. With a single subscription, you can gain instant access to a vast library of ASTM Medical Device Standards, as well as standards from other leading standards development organizations.

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Spanish Medical and Surgical Devices Standards Collection

The ASTM Medical and Surgical Devices Standards Collection includes standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices.

These standards include materials such as ceramics, metals, and polymers; it also includes standards to address needed fundamental information on biocompatibility, test methodology, and magnetic resonance imaging.

The orthopaedic devices area focuses on methods and practices for osteosynthesis, arthroplasty, and spinal devices. Tissue engineered medical products (TEMPs) standards focus on materials needed in, and practices and methods for, the development and application of TEMPs technologies.

Lastly, a division on computer assisted surgical systems includes a subcommittee on computer-assisted orthopaedic surgical systems (CAOS), which is writing standards for system accuracy.

ASTM Medical Device Standards Sections

  • Orthopaedic Devices
  • Medical and Surgical Devices
  • Tissue Engineered Medical Products
  • Polymeric Materials
  • Metallurgical Materials
  • Ceramic Materials
  • Material Test Methods
  • Biocompatibility Test Methods
  • Osteosynthesis
  • Arthroplasty
  • Spinal Devices
  • Cardiovascular Standards
  • Neurosurgical Standards
  • Plastic and Reconstructive Surgery
  • Mammary Implants
  • Medical and Surgical Instruments
  • Urological Materials and Devices
  • Gastrointestinal Applications
  • Implantable Hearing Devices (IHDs)
  • Computer Assisted Orthopaedic Surgical Systems (CAS systems)
  • Human Clinical Trials
  • Classification and Terminology for Tissue-Engineered Medical Products (TEMPs)
  • Biomaterials and Biomolecules for Tissue Engineered Medical Products (TEMPs)
  • Cells and Tissue Engineered Constructs for Tissue-Engineered Medical Products (TEMPs)
  • Assessment for Tissue-Engineered Medical Products (TEMPs)
  • Adventitious Agents Safety
  • Cell Signaling
  • Absorbable Metals
  • Implants for Surgery
  • Prosthetics and Orthotics

Benefits of Using ASTM Medical Device Standards

Many associations use and reference these ASTM Medical Devices standards, such as the American Academy of Orthopaedic Surgeons (AAOS), the Orthopaedic Surgical Manufacturers Association (OSMA), the American Association of Blood Banks (AABB), and the Association for the Advancement of Medical Instrumentation (AAMI).

AAOS and ASTM often work together to ensure that issues of importance to the surgical community are integrated into these standards. Similarly, OSMA supports these standards to provide transparency in trade for the manufacturing community.

AABB, as a reference in various standards, is becoming more of an integral player in the registry of tissue for TEMPs-related issues. Finally, AAMI and AMS (American Metallurgical Society) are responsible for other medically related standards work also utilized in the medical and surgical device community.

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AENOR UNE EN ISO Medical Standards

AENOR, the Spanish Association for Standardization and Certification, plays a crucial role in the development and dissemination of UNE (Una Norma Española) standards, particularly in the field of medical and surgical devices.

Among the most popular AENOR – UNE medical device standards are UNE-EN ISO 13485 and UNE-EN ISO 14971. UNE-EN ISO 13485 specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices, ensuring they consistently meet customer and regulatory requirements. UNE-EN ISO 14971 focuses on risk management for medical devices, outlining a systematic process for identifying, evaluating, and controlling risks associated with medical devices.

Accessing AENOR standards through ASTM Compass means that manufacturers can easily reference and apply these standards to their products, enhancing marketability and trust in various regions.

Learn More About AENOR UNE Standards

Digital Access to International Medical Device Standards

Whether you’re involved in research and development, manufacturing, quality control, or regulatory compliance, ASTM Compass has the tools and features to streamline your workflow.

You can easily bookmark, annotate, and share standards with your team, fostering collaboration and ensuring everyone is working with the most up-to-date information.
With ASTM Compass, you’ll never miss a critical update or revision to a standard.

The platform provides automatic notifications whenever a standard you’re following is modified, ensuring you’re always in compliance with the latest requirements.

Simplify your process with ASTM Compass and experience the convenience, reliability, and efficiency that only a world-class platform can provide.

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ASTM Medical Device Spanish Translations (Coming in 2025)

  • ASTM F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
  • ASTM F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
  • ASTM F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
  • ASTM F543 Specification and Test Methods for Metallic Medical Bone Screws
  • ASTM F640 Test Methods for Determining Radiopacity for Medical Use
  • ASTM F756 Practice for Assessment of Hemolytic Properties of Materials
  • ASTM F899 Specification for Wrought Stainless Steels for Surgical Instruments
  • ASTM F981 Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
  • ASTM F1350 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
  • ASTM F1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1980 Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
  • ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2063 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
  • ASTM F2077 Test Methods for Intervertebral Body Fusion Devices
  • ASTM F2129 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
  • ASTM F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2267 Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
  • ASTM F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • ASTM F2516 Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
  • ASTM F2554 Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
  • ASTM F2633 Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
  • ASTM F3127 Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
  • ASTM F3129 Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
  • ASTM F3208 Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

List of All ASTM Medical Device Standards

Arthroplasty Standards

  • ASTM F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
  • ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
  • ASTM F3143-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
  • ASTM F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
  • ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
  • ASTM F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
  • ASTM F370-94(1999) Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
  • ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
  • ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
  • ASTM F2091-15 Standard Specification for Acetabular Prostheses (Withdrawn 2023)
  • ASTM F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
  • ASTM F3161-16 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
  • ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
  • ASTM F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
  • ASTM F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
  • ASTM F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
  • ASTM F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
  • ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
  • ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
  • ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
  • ASTM F2025-06(2018) Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
  • ASTM F1714-96(2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
  • ASTM F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
  • ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
  • ASTM F1672-14(2019) Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
  • ASTM F2943-14(2019) Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
  • ASTM F2385-15(2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
  • ASTM F1800-19e1 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
  • ASTM F1612-95(2005) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion (Withdrawn 2011)
  • ASTM F1440-92(2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion (Withdrawn 2012)
  • ASTM F1636-95e2 Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)
  • ASTM F1715-00e1 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)
  • ASTM F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
  • ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
  • ASTM F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
  • ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
  • ASTM F1875-98(2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
  • ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants
  • ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
  • ASTM F2887-23 Standard Specification for Total Elbow Prostheses
  • ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
  • ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
  • ASTM F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
  • ASTM F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
  • ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

Assessment for TEMPs

  • ASTM F2529-13(2021) Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
  • ASTM F3223-17 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
  • ASTM F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
  • ASTM F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
  • ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
  • ASTM F2903-11 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
  • ASTM F2451-05(2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
  • ASTM F2884-21 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
  • ASTM F3225-17(2022) Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
  • ASTM F2721-09(2023) Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects

Biocompatibility Test Methods

  • ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
  • ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
  • ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
  • ASTM F2151-01 Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007)
  • ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
  • ASTM F895-11(2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
  • ASTM F2147-01(2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
  • ASTM F1877-16 Standard Practice for Characterization of Particles
  • ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
  • ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
  • ASTM F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
  • ASTM E1262-88(2018) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
  • ASTM F1984-99(2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
  • ASTM F1439-03(2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
  • ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
  • ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
  • ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
  • ASTM F2888-19 Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
  • ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
  • ASTM F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
  • ASTM E1280-97(2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity (Withdrawn 2015)
  • ASTM E1202-87(2008) Standard Guide for Development of Micronucleus Assay Standards (Withdrawn 2013)
  • ASTM E1397-91(2008) Standard Practice for In Vitro Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)
  • ASTM E1398-91(2008) Standard Practice for In Vivo Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)
  • ASTM E1263-97(2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes (Withdrawn 2015)
  • ASTM F2567-06(2010) Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
  • ASTM F2065-00(2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
  • ASTM F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)
  • ASTM F1905-98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
  • ASTM F719-20e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
  • ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
  • ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
  • ASTM F2808-23 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 F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
  • ASTM F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
  • ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

Biomaterials and Biomolecules for TEMPs

  • ASTM F3354-19 Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
  • ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
  • ASTM F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
  • ASTM F3274-21 Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
  • ASTM F2259-10(2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy (Withdrawn 2021)
  • ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
  • ASTM F3510-21 Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
  • ASTM F2605-16 Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
  • ASTM F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
  • ASTM F3142-16 Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
  • 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 F3515-21 Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications
  • ASTM F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
  • ASTM F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
  • ASTM F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
  • ASTM F2602-18 Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
  • ASTM F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
  • ASTM F2883-11 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
  • ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
  • ASTM F2603-06(2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
  • ASTM F2131-21 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 F2952-22 Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
  • ASTM F3089-23 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
  • ASTM F2791-24 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
  • ASTM F3659-24 Standard Guide for Bioinks Used in Bioprinting

Cardiovascular Standards

  • ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
  • ASTM F1841-19e1 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
  • ASTM F3067-14(2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
  • ASTM F2606-08(2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
  • ASTM F3172-15(2021) Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
  • ASTM F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
  • ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
  • ASTM F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
  • ASTM F3320-18 Standard Guide for Coating Characterization of Drug Coated Balloons
  • ASTM F2743-11(2018) Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
  • ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
  • ASTM F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
  • ASTM F3036-21 Standard Guide for Testing Absorbable Stents
  • ASTM F2079-09(2022) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
  • ASTM F2081-06(2022) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
  • ASTM F2394-07(2022) Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System
  • ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
  • ASTM F2914-12(2024) Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
  • ASTM F3575-24 Standard Guide for Model Development for Particulate Generation Testing of Endovascular Devices

Cell Signaling

  • F2998-14 Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells (Withdrawn 2023)
  • F3294-18 Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy

Cells and Tissue Engineered Constructs for TEMPs

  • ASTM F2739-19 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
  • ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
  • ASTM F3209-16 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
  • ASTM F2386-04 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
  • ASTM F2997-21 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
  • ASTM F2149-16 Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
  • ASTM F2664-19e1 Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
  • ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
  • ASTM F3369-19e1 Standard Guide for Assessing the Skeletal Myoblast Phenotype
  • ASTM F2210-02(2010) Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
  • ASTM F2944-20 Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
  • ASTM F3504-21 Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
  • ASTM F3106-22 Standard Guide for in vitro Osteoblast Differentiation Assays
  • ASTM F3088-22 Standard Practice for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
  • ASTM F3570-22 Standard Terminology Relating to Microphysiological Systems

Ceramic Materials

  • ASTM F1926/F1926M-14(2021) Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
  • ASTM F1658-95 Test Method for Shear Testing of Calcium Phosphate Coatings (Withdrawn 2000)
  • ASTM F1659-95 Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates (Withdrawn 2005)
  • ASTM F1501-95 Test Method for Tension Testing of Calcium Phosphate Coatings (Withdrawn 2000)
  • ASTM F1873-98 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)
  • ASTM F603-12(2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
  • ASTM F2393-12(2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
  • ASTM F1581-08(2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
  • ASTM F2224-09(2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
  • ASTM F2024-10(2021) Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
  • ASTM F1088-23 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
  • ASTM F1185-23 Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
  • ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
  • ASTM F1538-24 Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation

Classification and Terminology for TEMPs

  • ASTM F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)
  • ASTM F2312-11(2020) Standard Terminology Relating to Tissue Engineered Medical Products
  • ASTM F2311-08 Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
  • ASTM F3163-22 Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds

Computer Assisted Orthopedic Surgical Systems

  • ASTM F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
  • ASTM F3107-14(2023) Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

Consumer Rubber Products

  • ASTM D3772-15(2021) Standard Specification for Industrial Rubber Finger Cots
  • ASTM D7427-16(2021) Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex (Withdrawn 2023)
  • ASTM D8389-21 Standard Performance Specification for Urinary Intermittent Catheters
  • ASTM D7329-07(2018) Standard Specification for Food Preparation and Food Handling (Food Service) Gloves
  • ASTM D6976-13(2018) Standard Specification for Rubber Contraceptives—Vaginal Diaphragms
  • ASTM D7558-09(2019) Standard Test Method for Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram, and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves
  • ASTM D7907-14(2019) Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
  • ASTM D7850-19 Standard Specification for Biological Properties of Industry Reference Materials (IRM)
  • ASTM D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
  • ASTM F623-19 Standard Performance Specification for Foley Catheter
  • ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
  • ASTM D4679-21 Standard Specification for Rubber General Purpose, Household or Beautician Gloves
  • ASTM D8419-21 Standard Specification for Anesthesia Reservoir Bags
  • ASTM D7246-06(2021) Standard Test Method for Detection of Holes in Polyethylene Food Service Gloves
  • ASTM D6355-07(2022) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
  • ASTM D7102-17(2022) Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
  • ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
  • ASTM D3899-93e2 Standard Specification for Rubber Contraceptives-Vaginal Diaphragms (Withdrawn 2002)
  • ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
  • ASTM D3579-77(2023) Standard Specification for Rubber Surgical Drainage Tubes, Penrose-Type
  • ASTM D6324-11(2023) Standard Specification for Male Condoms Made from Polyurethane
  • ASTM D6499-18(2023) Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
  • ASTM D7160-16(2023) Standard Practice for Determination of Expiration Dating for Medical Gloves
  • ASTM D7161-16(2023) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
  • ASTM D7198-05(2023) Standard Specification for Disposable Embalming Gloves for Single-Use Applications
  • ASTM D8238-18(2023) Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins
  • ASTM D6284-17(2023) Standard Test Method for Rubber Property—Effect of Aqueous Solutions with Available Chlorine and Chloramine
  • ASTM D3577-19(2023) Standard Specification for Rubber Surgical Gloves
  • ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
  • ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves
  • ASTM D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
  • ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
  • ASTM D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
  • ASTM D6978-05(2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
  • ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves
  • ASTM D7661-23 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
  • ASTM D4316-95(2023) Standard Specification for Elastomeric Water Bottles

GI Applications

  • ASTM F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera (Withdrawn 2009)
  • ASTM F1992-99(2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)
  • ASTM F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

Human Clinical Trials

  • ASTM F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
  • ASTM F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
  • ASTM F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery

Implantable Hearing Devices (IHDs)

  • ASTM F2504-05(2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

Plastic and Reconstructive Surgery

  • ASTM F703-18(2022) Standard Specification for Implantable Breast Prostheses
  • ASTM F881-94(2022) Standard Specification for Silicone Elastomer Facial Implants
  • ASTM F1441-03(2022) Standard Specification for Soft-Tissue Expander Devices
  • ASTM F2051-00(2022) Standard Specification for Implantable Saline-Filled Breast Prostheses

Material Test Methods

  • ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
  • ASTM F3487-20 Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
  • ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
  • ASTM F2381-19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
  • ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
  • ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
  • ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024)
  • ASTM F2255-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
  • ASTM F2392-04(2015) Standard Test Method for Burst Strength of Surgical Sealants
  • ASTM F2258-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
  • ASTM F2256-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
  • ASTM F2458-05(2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
  • ASTM F1634-95(2016) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017)
  • ASTM F746-04(2021) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
  • ASTM F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
  • ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
  • ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • ASTM F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
  • ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
  • ASTM F2819-10(2015)e2 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
  • ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
  • ASTM F1044-05(2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
  • ASTM F1160-14(2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
  • ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments
  • ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
  • ASTM F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
  • ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
  • ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
  • ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
  • ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
  • ASTM F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
  • ASTM F3335-20 Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
  • ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix, and Direction of Helix of Coiled Wire
  • ASTM F2183-02(2008) Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
  • ASTM F2118-14(2020) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
  • ASTM F2778-09(2020) Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
  • ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
  • ASTM F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
  • ASTM F1536-95(2015)e1 Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape (Withdrawn 2021)
  • ASTM F3268-18a Standard Guide for in vitro Degradation Testing of Absorbable Metals
  • ASTM F3275-22 Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
  • ASTM F3336-22 Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
  • ASTM F3276-22 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
  • ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2516-22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
  • ASTM F1978-22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
  • ASTM F3127-22 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
  • ASTM F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
  • ASTM F640-23 Standard Test Methods for Determining Radiopacity for Medical Use
  • ASTM F3109-23 Standard Practice for Verification of Multi-Axis Force Measuring Platforms
  • ASTM F3602-23 Standard Guide for Assessing the Compatibility of a Cleaning Brush Part with Different Substrates Used in the Construction of Medical Devices
  • ASTM F2214-23 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
  • ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
  • ASTM F2082/F2082M-23 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
  • ASTM F2503-23e1 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • ASTM F2995-24 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
  • ASTM F3438-24 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
  • ASTM F2625-24 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 F1147-24 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
  • ASTM F2119-24 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

Medical/Surgical Instruments

  • ASTM F3014-14 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures (Withdrawn 2023)
  • ASTM F1744-96(2016) Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
  • ASTM E667-98(2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers (Withdrawn 2022)
  • ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
  • ASTM F2062-00(2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
  • ASTM F1078-10(2018) Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
  • ASTM F921-10(2018) Standard Terminology Relating to Hemostatic Forceps
  • ASTM F882-84(2002) Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
  • ASTM F1874-98(2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures (Withdrawn 2020)
  • ASTM F2132-01(2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps (Withdrawn 2017)
  • ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
  • ASTM F1026-86(2022) Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
  • ASTM F1079-87(2022) Standard Specification for Inserted and Noninserted Surgical Scissors
  • ASTM F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
  • ASTM F1613-95(2023) Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
  • ASTM F1638-95(2023) Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
  • ASTM F1840-10(2023) Standard Terminology for Surgical Suture Needles
  • ASTM E825-98(2023) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
  • ASTM E1104-98(2023) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
  • ASTM E1299-96(2023) Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature
  • ASTM E1965-98(2023) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
  • ASTM F1325-91(2023) Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods

Metallurgical Materials

  • ASTM F563-00 Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
  • ASTM F2229-21 Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
  • ASTM F1341-99 Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications (Withdrawn 2006)
  • ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
  • ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
  • ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
  • ASTM F1058-16 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
  • ASTM F621-12(2021)e1 Standard Specification for Stainless Steel Forgings for Surgical Implants
  • ASTM F136-13(2021)e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
  • ASTM F67-13(2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
  • ASTM F2581-12(2017) Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
  • ASTM F1813-21 Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
  • ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
  • ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
  • ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
  • ASTM F1580-18 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
  • ASTM F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
  • ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
  • ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
  • ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
  • ASTM F139-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
  • ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
  • ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
  • ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
  • ASTM F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
  • ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
  • ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
  • ASTM F745-07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
  • ASTM F2181-20 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
  • ASTM F3046-21 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)
  • ASTM F3273-17(2021)e1 Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
  • ASTM F2989-21 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
  • ASTM F1713-08(2021)e1 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
  • ASTM F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
  • ASTM F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
  • ASTM F2146-22 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
  • ASTM F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
  • ASTM F2257-22 Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
  • ASTM F1472-23 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
  • ASTM F2885-17(2023) Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
  • ASTM F90-23 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
  • ASTM F2066-23 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
  • ASTM F75-23 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
  • ASTM F2886-17(2023) Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
  • ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
  • ASTM F899-23 Standard Specification for Wrought Stainless Steels for Surgical Instruments
  • ASTM F2527-24 Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
  • ASTM F1295-24 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
  • ASTM F1350-24 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
  • ASTM F2384-24 Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
  • ASTM F1314-24 Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

Neurosurgical Standards

  • ASTM F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)
  • ASTM F1831-17 Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
  • ASTM F1266-89(2008) Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)
  • ASTM F982-86(2008) Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
  • ASTM F622-79(2002) Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
  • ASTM F1719-96(2008) Standard Specification for Image-Interactive Stereotactic and Localization Systems (Withdrawn 2017)
  • ASTM F701-81(2008) Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017)
  • ASTM F700-93(2022) Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
  • ASTM F647-22 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
  • ASTM F452-76(2022) Standard Specification for Preformed Cranioplasty Plates

Osteosynthesis

  • ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
  • ASTM F117-95(1999)e1 Test Method for Driving Torque of Medical Bone Screws (Withdrawn 2001)
  • ASTM F1028-86(1991) Specification for Tri-Fin Nails (Withdrawn 1996)
  • ASTM F1622-95(2000) Test Method for Measuring the Torsional Properties of Metallic Bone Screws (Withdrawn 2001)
  • ASTM F1745-96 Test Method for External Fixator Connectors (Withdrawn 2000)
  • ASTM F1746-96 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements (Withdrawn 2000)
  • ASTM F1747-96 Test Method for External Fixator Joints (Withdrawn 2000)
  • ASTM F1748-96 Test Method for External Fixator Subassemblies (Withdrawn 2000)
  • ASTM F1539-95(1999) Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples (Withdrawn 2000)
  • ASTM F1691-96 Test Method for Determining Axial Pull-Out Strength of Medical Bone Screws (Withdrawn 2001)
  • ASTM F1540-95(1999) Test Method for Pull-Out Fixation Strength of Metallic Bone Staples (Withdrawn 2000)
  • ASTM F1660-95(1999) Test Method for Elastic Static Bending of Metallic Bone Staples (Withdrawn 2000)
  • ASTM F1610-95(1999) Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples (Withdrawn 2000)
  • ASTM F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
  • ASTM F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices
  • ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
  • ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables
  • ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
  • ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
  • ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
  • ASTM F983-86(2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
  • ASTM F1611-20 Standard Specification for Intramedullary Reamers
  • ASTM F116-12(2021) Standard Specification for Medical Screwdriver Bits
  • ASTM F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
  • ASTM F787-82(1991) Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)
  • ASTM F367-81(1991) Specification for Holes and Slots for Inch Cortical Bone Screws (Withdrawn 1997)
  • ASTM F544-92 Reference Chart for Pictorial Cortical Bone Screw Classification (Withdrawn 1998)
  • ASTM F3437-23 Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
  • ASTM F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws
  • ASTM F366-24 Standard Specification for Fixation Pins and Wires

Polymeric Materials

  • ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
  • ASTM F754-08(2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
  • ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
  • ASTM F604-94 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
  • ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
  • ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
  • ASTM F624-09(2015)e1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
  • ASTM F665-09(2015) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
  • ASTM F602-09(2015) Standard Criteria for Implantable Thermoset Epoxy Plastics
  • ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
  • ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
  • ASTM F451-21 Standard Specification for Acrylic Bone Cement
  • ASTM F2902-16e1 Standard Guide for Assessment of Absorbable Polymeric Implants
  • ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
  • ASTM F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
  • ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
  • ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
  • ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
  • ASTM F2313-18 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
  • ASTM F1855-00(2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
  • ASTM F2759-19 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
  • ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
  • ASTM F1579-02e1 Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)
  • ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
  • ASTM F1876-98(2003)e1 Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn 2012)
  • ASTM F2695-12(2020) Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
  • ASTM F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
  • ASTM F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
  • ASTM F641-09(2023) Standard Specification for Implantable Epoxy Electronic Encapsulants
  • ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
  • ASTM F639-09(2024) Standard Specification for Polyethylene Plastics for Medical Applications

Spinal Devices

  • ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
  • ASTM F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
  • ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1582-98(2016) Standard Terminology Relating to Spinal Implants
  • ASTM F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses
  • ASTM F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
  • ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
  • ASTM F2790-10(2019)e1 Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
  • ASTM F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
  • ASTM F2789-10(2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
  • ASTM F2694-16(2020) Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
  • ASTM F2624-12(2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
  • ASTM F2423-11(2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
  • ASTM F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
  • ASTM F2077-22 Standard Test Methods for Intervertebral Body Fusion Devices
  • ASTM F3631-24 Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
  • ASTM F2267-24 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Urological Materials and Devices

  • ASTM F1828-22 Standard Specification for Ureteral Stents
discussion

Join the ASTM Medical and Surgical Materials and Devices Committee

ASTM formed the Medical and Surgical Materials and Devices (F04) Committee, which focused specifically on creating standards for the rapidly growing medical device sector. This committee brought together medical professionals, engineers, scientists, and industry leaders to develop standards that addressed the unique challenges and requirements of medical devices.

The Medical and Surgical Materials and Devices committee meets twice each year, in May and November, with about 190 members attending over two days of technical meetings capped by a symposium or workshop on relevant topics in the medical/surgical materials and device industry. The Committee, with a membership of 1050, currently has jurisdiction of over 338 standards, published in the Annual Book of ASTM Standards, Volumes 13.02.

ASTM Committee on Medical and Surgical Materials and Devices

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