ASTM is one of the leading developers of standards for medical devices. EUROLAB Lab; ASTM medical device standards cover a truly broad spectrum, with 24 categories addressing everything from surgical instruments to automated analysis. As much research and education goes into the medical industry, standardization plays a key role in accomplishing this effort efficiently. There are over 300 standards organized below for your convenience by use, industry and theme.
ASTM test standards are in the following categories.
Medical/Surgical Instruments
ASTM F1980-21
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
ASTM E1061-01(2014)
Standard Specification for Direct-Read Liquid Crystal Forehead Thermometers
ASTM F1026-86 (2014)
Standard Specification for General Labor and Performance Measurements of Hemostatic Forceps
ASTM F1079-87 (2014)
Standard Specification for Attached and Unmounted Surgical Scissors
ASTM F3014-14
Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
ASTM E1112-00(2018)
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
ASTM F921-10 (2018)
Standard Terminology for Hemostatic Forceps
ASTM F1078-10 (2018)
Standard Terminology for Surgical Scissors—Attached and Unattached Blades
ASTM F1874-98 (2011)
Standard Test Method for Bending Needles Used in Surgical Sutures
ASTM F2062-00 (2018)
Standard Specification for Square Drive Interconnects in Surgical Instruments
ASTM E1299-96(2016)
Standard Specification for the Reusable Phase Change Type Fever Thermometer for the Intermittent Determination of Human Temperature
ASTM E667-98(2017)
Mercury-Mercury, Standard Specification for Maximum Self-Registering Clinical Thermometers
ASTM E825-98(2016)
Standard Specification for a Phase Change Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
ASTM E1104-98(2016)
Standard Specification for Clinical Thermometer Probe Covers and Cases
ASTM E1965-98(2016)
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
ASTM F1840-10 (2016)
Standard Terminology for Surgical Suture Needles
ASTM F1325-91 (2016)
Standard Specification for Stainless Steel Sewing Needle Holders - General Labor Requirements and Corresponding Test Methods
ASTM F1613-95 (2016)
Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
ASTM F1638-95(2016)e1
Standard Terminology for Surgical Tissue/Garment/Pick-Up Forceps (Thumb Type)
ASTM F1744-96 (2016)
Standard Guide for the Care and Use of Stainless Steel Surgical Instruments
ASTM F2132-01(2008)e1
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
Adventurous Agents Security
ASTM F2383-11
Standard Guide to Evaluation of Adventitious Agents in Tissue Engineered Medicinal Products (TEMPs)
Arthroplasty
ASTM F3161-16
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopedic Total Knee Femoral Components at Closing Conditions
ASTM F1781-21
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
ASTM F1814-15
Standard Guide to Evaluating Modular Hip and Knee Joint Components
ASTM F2068-15
Standard Specification for Femoral Prostheses—Metallic Implants
ASTM F2091-15
Standard Specification for Acetabular Prostheses
ASTM F2385-15 (2019)
Standard Practice for Determining Femoral Head Penetration into the Acetabular Components of Total Hip Replacement Using Clinical Radiographs
ASTM F2722-21
Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotation Stops
ASTM F3047M-15
Standard Guide for High-Demand Hip Simulator Abrasion Testing of Rigid Articulations
ASTM F3141-17a
Standard Guide for Total Knee Replacement Loading Profiles
ASTM F1223-20
Standard Test Method for Determining Total Knee Replacement Restriction
ASTM F1357-14 (2019)
Standard Specification for Articulation of Total Wrist Implants
ASTM F1672-14 (2019)
Standard Specification for Resurfacing Patellar Prosthesis
ASTM F2028-17
Standard Test Methods for Dynamic Evaluation of Glenoid Relaxation or Separation
ASTM F2582-20
Standard Test Method for Dynamic Compression Between Femoral and Acetabular Hip Components
ASTM F2943-14 (2019)
Standard Guide to the Presentation of End-User Labeling Information for Musculoskeletal Implants
ASTM F2979-20
Standard Guide for Characterization of Articulated Surface Wear in Reclaimed Metal-on-Metal and other Hard-on-Rigid Hip Prostheses
ASTM F2665-21
Standard Specification of Total Ankle Prosthesis
ASTM F2724-21
Standard Test Method for Evaluation of Mobile Bearing Knee Dislocation
ASTM F1820-13
Standard Test Method for Determining Forces to Disassemble Modular Acetabular Devices
ASTM F2580-18
Standard Practice for Evaluating the Modular Attachment of a Proximal Fixation Femoral Hip Replacement
ASTM F2978-20
Standards Guide for Optimizing Scanning Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices Using Magnetic Resonance Imaging
ASTM F2996-20
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopedic Hip Femur Roots
ASTM F1714-96 (2018)
Standard Guide for Gravimetric Wear Evaluation of Prosthetic Hip Designs on Simulator Devices
ASTM F2345-21
Standard Test Methods for Determining the Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
ASTM F2723-21
Mobile Bearing Knee Tibial Baseplate/Standard Test Method for Evaluating Bearing Resistance to Dynamic Disengagement
ASTM F1378-18e1
Standard Specification for Shoulder Prostheses
ASTM F1800-19
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F2033-20
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bed Surfaces Made of Metallic, Ceramic, and Polymeric Materials
ASTM F2083-21
Standard Specification for the Knee Replacement Prosthesis
ASTM F2887-17
Standard Specification for Total Elbow Prostheses
ASTM F2025-06 (2018)
Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Evaluation
ASTM F2009-20
Standard Test Method for Determining Axial Disassembly Force of Conical Connections of Modular Dentures
ASTM F2777-16
Standard Test Method for Evaluating Strength and Deformation of the Tibial Insert under High Flexion
ASTM F1829-17
Standard Test Method for Static Evaluation of Anatomical Glenoid Locking Mechanism in Cutting
Evaluation for TEMPs
ASTM F2721-09 (2014)
Standard Guidelines for Preclinical Evaluation of Critical-Size Segmental Bone Defects in vivo
ASTM F2529-13 (2021)
Standard Guide to Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) in vivo
ASTM F2884-12
Standard Guidelines for Preclinical Evaluation of Spinal Fusion in Live
ASTM F2903-11
Standard Guide for Tissue Engineered Medical Products (TEMPs) to Enhance Tendon and Ligament Surgical Repair
ASTM F2451-05 (2010)
Standard Guide for In vivo Evaluation of Implantable Devices Intended for Articular Cartilage Repair or Regeneration
Biocompatibility Test Methods
ASTM F619-20
Standard Practice for Extraction of Materials Used in Medical Devices
ASTM F1904-14
Standard Practice for Testing Biological Responses to Particles in vivo
ASTM F1983-14
Standard Practice for Evaluating Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM E1262-88(2018)
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
ASTM F720-17
Standard Practice for Testing for Contact Allergens in Guinea pigs: Guinea pig Maximization Test
ASTM F749-20
Standard Practice for Evaluation of Material Extracts by Intracutaneous Injection in the Rabbit
ASTM F756-17
Standard Practice for Evaluating Hemolytic Properties of Materials
ASTM F1408-20a
Standard Practice for Subcutaneous Screening Test for Implant Materials
ASTM F1439-03 (2018)
Standard Guide for Lifetime Bioassay Performance for Tumorigenic Potential of Implant Materials
ASTM F1984-99 (2018)
Standard Practice for Testing Full Complement Activation in Serum with Solids
ASTM F2148-18
Standard Practice for Evaluating Delayed Contact Hypersensitivity Using Murine Local Lymph Node Test (LLNA)
ASTM F2888-19
Standard Practice for Platelet Leukocyte Count—Hemocompatibility Assessment Measurement of Cardiovascular Materials in a Lab Setting
ASTM F2901-19
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
ASTM F719-20e1
Standard Practice for Testing Ingredients in Rabbits for Primary Skin Irritation
ASTM F750-20
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
ASTM F813-20
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
ASTM F1027-86 (2017)
Standard Practice for Evaluating Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM F895-11 (2016)
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F748-16
Standard Practice for Selecting General Biological Test Methods for Materials and Devices
ASTM F763-04 (2016)
Standard Practice for Short-Term Screening of Implant Materials
ASTM F981-04 (2016)
Standard Practice for Evaluating the Compatibility of Biomaterials for Surgical Implants with respect to the Effect of Materials on Muscle and Attachment to Bone
ASTM F1877-16
Standard Practice for Characterization of Particles
ASTM F1903-18
Standard Practice for Testing Cellular Responses to Particles in a laboratory setting
ASTM F2147-01 (2016)
Standard Practice for the Guinea Pig: Split Adjuvant and Closed Patch Test for Contact Allergens
ASTM F2382-18
Standard Test Method for Evaluation of Medical Device Materials in Contact with Circulating Blood at Partial Thromboplastin Time (PTT)
ASTM F2808-17
Standard Test Method for Performing the Back of the Knee (BTK) Test to Evaluate Skin Irritation Response to Products and Materials with Repeated or Prolonged Skin Contact
Biomaterials and Biomolecules for TEMPs
ASTM F2347-15
Standard Guide for the Characterization and Testing of Hyaluronan as Starting Materials for Use in Biomedical and Tissue Engineered Medicinal Product Applications
ASTM F2791-15
Standard Guide for Two-Dimensional Evaluation of Surface Texture of Non-Porous Biomaterials
ASTM F2064-17
Standard Guide for Characterization and Testing of Alginates as Starting Materials for Use in Biomedical and Tissue Engineering Medicinal Product Applications
ASTM F2952-14
Standard Guide for Determining the Average Darcy Permeability Coefficient for a Porous Tissue Scaffold
ASTM F3089-14
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ASTM F2150-19
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Medicinal Products Used in Regenerative Medicine and Tissue Engineering
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 F2131-21
Standard Test Method for In vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-20 (rhBMP-2) Using W-2 Mouse Stromal Cell Line
ASTM F2603-06 (2020)
Standard Guide to Interpreting Images of Polymeric Tissue Scaffolds
ASTM F2259-10(2012)e1
Standard Test Method for Determination of Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance ( 1 H NMR) Spectroscopy
ASTM F2260-18
Standard Test Method for Determining the Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance ( 1 H NMR) Spectroscopy
ASTM F2103-18
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials for Use in Biomedical and Tissue Engineering Medicinal Product Applications
ASTM F2212-20
Standard Guide to the Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
ASTM F2883-11
Standard Guide for Characterization of Ceramic and Mineral-Based Scaffolds Used as Devices for Tissue Engineered Medical Products (TEMPs) and Surgical Implant Applications
ASTM F2900-11
Standard Guide for Characterization of Hydrogels Used in Regenerative Medicine
ASTM F2450-18
Standard Guide to Evaluating the Microstructure of Polymeric Scaffolds for Use in Tissue-Engineering Medical Products
ASTM F2027-16
Standard Guide for Characterization and Testing of Raw or Starting Materials 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)
Cardiovascular Standards
ASTM F3172-15 (2021)
Design Validation for Endovascular Devices Standard Guide for Device Size and Specimen Size Selection
ASTM F3067-14 (2021)
Standard Guide for Radial Loading of Balloon Expandable and Self-Expanding Vascular Stents
ASTM F2514-21
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
ASTM F2606-08 (2021)
Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
ASTM F2942-19
Axial, Flexural, and Torsional Strength Testing of Vascular Stents in a Standard Guide Laboratory setting
ASTM F3036-21
Standard Guide for Testing Absorbable Stents
ASTM F1830-19
Standard Practice for Blood Collection and Preparation for Dynamic Evaluation of Hemolysis on Blood Pumps in the laboratory setting
ASTM F1841-19e1
Standard Practice for Evaluation of Hemolysis in Continuous Flow Blood Pumps
ASTM F2079-09 (2017)
Standard Test Method for Measuring Intrinsic Elastic Rebound of Balloon Expandable Stents
ASTM F2081-06 (2017)
Standard Guide for the Characterization and Presentation of Dimensional Properties of Vascular Stents
ASTM F2394-07 (2017)
Standard Guide for Measuring Fixation of a Balloon Expandable Vascular Stent Mounted to a Delivery System
ASTM F2477-19
Standard Test Methods forPulsatile Strength Testing of Vascular Stents in a laboratory setting
ASTM F2914-12 (2018)
Standard Guide to Determining Shelf-Life Assay Qualities for Endovascular Devices
ASTM F2743-11 (2018)
Standard Guide for Coating Inspection and Acute Particle Characterization of Coated Drug-Eluting Vascular Stent Systems
cell signal
ASTM F2998-14
User's Guide to Fluorescent Microscopy to Measure the Spreading Area of Fixed Cells
Cells and Tissue Engineering Structures for TEMPs
ASTM F3088-14
Standard Test Method for Using the Centrifuge Method to Quantify/Study Cell-Material Adhesive Interactions
ASTM F3106-14
Osteoblast Differentiation Assays in Laboratory Medium with Standard Guidelines
ASTM F2997-21
Standard Practice for Quantification of Calcium Accumulations in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
ASTM F2944-20
Standard Practice for Automated Colony Formation Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumeration and Characterization of Cells and Colonies in Culture
ASTM F2315-18
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissues in Alginate Gels
ASTM F2664-19e1
Standard Guide to Evaluating Physical Attachment of Cells to Biomaterial Surfaces
ASTM F2739-19
Standard Guide to Measuring Cell Viability and Related Attributes in Biomaterial Scaffolds
ASTM F2149-16
Standard Test Method for Automated Analysis of Cells—Electric Detection Zone Method for Numbering and Sizing of Single Cell Suspensions
Ceramic Materials
ASTM F1926/F1926M-14(2021)
Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Manufactured Forms and Coatings
ASTM F1185-03 (2014)
Standard Specification for Hydroxylapatite Composition for Surgical Implants
ASTM F1609-08 (2014)
Standard Specification for Calcium Phosphate Coatings for Implantable Materials
ASTM F2224-09 (2020)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
ASTM F603-12 (2020)
Standard Specification for High-Purity Condensed Aluminum Oxide for Medical Application
ASTM F1581-08 (2020)
Standard Specification for Inorganic Bone Composition for Surgical Implants
ASTM F2393-12 (2020)
Standard Specification for High Purity Condensed Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
ASTM F1088-18
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
ASTM F2024-10 (2021)
Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma Spray Hydroxyapatite Coatings
ASTM F1538-03 (2017)
Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation
Classification and Terminology for TEMPs
ASTM F3163-16
Standard Guide for Classification of Cellular and/or Tissue Based Products (CTPs) for Skin Wounds
ASTM F2211-13 (2021)
Standard Classification for Tissue Engineered Medicinal Products (TEMPs)
ASTM F2312-11 (2020)
Standard Terminology for Medical Products Manufactured in Tissue Engineering
ASTM F2311-08
Standard Guide for Classification of Therapeutic Skin Substitutes
Computer Aided Orthopedic Surgery Systems
ASTM F3107-14
Standard Test Method for Measuring Accuracy After Mechanical Disturbances in Reference Frames of Computer-Aided Surgical Systems
ASTM F2554-18
Standard Practice for Measuring Positional Accuracy of Computer-Aided Surgical Systems
Editorial and Terminology
ASTM F2809-10
Standard Terminology for Medical and Surgical Equipment and Devices
GI Applications
ASTM F2528-06 (2014)
Standard Test Methods for Retention Balloon Enteral Feeding Devices
ASTM F1992-99 (2007)
Standard Practice for Reprocessing Reusable, Heat Resistant Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
Human Clinical Trials
ASTM F3037-15
Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs)
Implantable Hearing Aids (IHDs)
ASTM F2504-05 (2014)
Standard Practice for Defining System Output of Implantable Middle Ear Hearing Aids
Medical Material Test Methods
ASTM F1854-15
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
ASTM F2052-21
Standard Test Method for Measurement of Magnetically Induced Displacement Force in Medical Devices in a Magnetic Resonance Environment
ASTM F2082-15
Standard Test Method for Determining the Conversion Temperature of Nickel-Titanium Shape Memory Alloys by Flexural and Free Recovery
ASTM F2129-19a
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine Corrosion Susceptibility of Small Implant Devices
ASTM F1536-95(2015)e1
Standard Test Method for Determining Strength and Curing Time of Synthetic Water Activated Polyurethane Fiberglass Orthopedic Casting Tape
ASTM F2003-02 (2015)
Standard Practice for Accelerated Aging of Ultra High Molecular Weight Polyethylene After Gamma Irradiation in Air
ASTM F2255-05 (2015)
Standard Test Method for Tensile Loading Strength Properties of Tissue Adhesives in Lap-Shear
ASTM F2256-05 (2015)
Standard Test Method for Strength Properties of T-Peel with Tensile Loading of Tissue Adhesives
ASTM F2258-05 (2015)
Standard Test Method for Strength Properties of Tissue Adhesives in Tension
ASTM F2392-04 (2015)
Standard Test Method for Bursting Strength of Surgical Sealants
ASTM F2458-05 (2015)
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
ASTM F2778-09 (2020)
Standard Test Method for Measuring Percent Crystallinity of Polyetheretherketone (PEEK) Polymers via Specular Reflection Fourier Transform Infrared Spectroscopy (R-FTIR)
ASTM F2819-10(2015)e2
Standard Test Methods for Accuracy Measurement of Rod, Rod, Tube, and Wire for Medical Devices
ASTM F746-04 (2021)
Standard Test Method for Pitting or Crack Corrosion of Metallic Surgical Implant Materials
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 F1801-20
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
ASTM F1875-98 (2014)
Standard Practice for Friction Corrosion Testing of Modular Implant Interfaces: Hip Femur Head-Bore and Tapered Conical Interface
ASTM F2118-14 (2020)
Standard Test Method for Constant Amplitude of Force-Controlled Fatigue Test of Acrylic Bone Cement Materials
ASTM F2516-18
Standard Test Method for Tensile Testing of Nickel-Titanium Superelastic Materials
ASTM F3044-20
Standard Test Method for Evaluating Galvanic Corrosion Potential for Medical Implants
ASTM F561-19
Standard Practice for Retrieval and Analysis of Medical Devices and Associated Tissues and Fluids
ASTM F897-19
Standard Test Method for Measuring Friction Corrosion of Osteosynthesis Plates and Screws
ASTM F2102-17
Standard Guide to Evaluating the Extent of Oxidation in Polyethylene Forms for Surgical Implants
ASTM F2119-07 (2013)
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2503-20
Standard Practice for Marking Medical Devices and Other Items for Safety in a Magnetic Resonance Environment
ASTM F2754/F2754M-21
Standard Test Method for Measurement of Camber, Casting, Helical and Helical Direction of Helical Wire
ASTM F2977-20
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
ASTM F2995-16
Standard Guide for Transport of Potentially Infectious Materials, Tissues and Liquids
ASTM F640-20
Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F1978-18
Standard Test Method for Measuring the Wear Resistance of Metallic Thermal Spray Coatings Using Taber Abrasive
ASTM F2459-18
Standard Test Method for Residue Extraction from Metallic Medical Components and Quantification by Gravimetric Analysis
ASTM F2182-19e2
Standard Test Method for the Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
ASTM F1044-05(2017)e1
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
ASTM F732-17
Standard Test Method for Abrasion Testing of Polymeric Materials Used in Total Joint Prostheses
ASTM F1147-05(2017)e1
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1635-16
In vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Manufactured Forms for Surgical Implants
ASTM F2213-17
Standard Test Method for Measuring Magnetically Induced Torque in Medical Devices in a Magnetic Resonance Environment
ASTM F2537-06 (2017)
Standard Practice for Calibrating Linear Displacement Sensor Systems Used to Measure Micromotion
ASTM F2004-17
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM F2381-19
Standard Test Method for Evaluating Trans-vinylene Yield in Irradiated Ultra High Molecular Weight Polyethylene Forms for Surgical Implants by Infrared Spectroscopy
ASTM F2625-10 (2016)
Standard Test Method for the Measurement of Fusion Enthalpy, Percent Crystallinity, and Melting Point of Ultra-High Molecular Weight Polyethylene by Differential Scanning Calorimetry
ASTM F2847-17
Standard Practice for Reporting and Evaluation of Residue on Disposable Implants and Sterile Disposable Instruments
ASTM F1634-95 (2016)
Standard Practice for In vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
ASTM F2183-02 (2008)
Standard Test Method for Small Punch Testing of Ultra High Molecular Weight Polyethylene Used in Surgical Implants
ASTM F2214-16
Determination of Network Parameters of In-situ Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
Metallurgical Medical Materials
ASTM F629-20
Standard Practice for Radiography of Cast Metallic Surgical Implants
ASTM F1350-15
Standard Specification for Forged 18Chrome-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
ASTM F2005-21
Standard Terminology for Nickel-Titanium Shape Memory Alloys
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 Alpha Plus Beta Condition
ASTM F90-14
Standard Specification for Forged Cobalt-20Chrome-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
ASTM F688-19
Standard Specification for Forged Cobalt-35Nickel-20Chrome-10Molybdenum-Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
ASTM F961-20
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
ASTM F1108-21
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
ASTM F1472-20a
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
ASTM F2181-20
Standard Specification for Forged Seamless Stainless Steel Tubing for Surgical Implants
ASTM F2257-14
Standard Specification for Small-Diameter Tubing for Forged Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Implants (UNS S31673)
ASTM F67-13 (2017)
Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
ASTM F86-21
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
ASTM F136-13(2021)e1
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra-Low Intermediate) Alloy for Surgical Implant Applications (UNS R56401)
ASTM F562-22
Standard Specification for Forging 35Cobalt-35Nickel-20Chrome-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
ASTM F601-18
Standard Practice for Fluorescent Penetrating Examination of Metallic Surgical Implants
ASTM F1377-21
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537 and UNS R31538)
ASTM F1713-08(2021)e1
Standard Specification for Forged Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
ASTM F1813-21
Standard Specification for Forged Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
ASTM F2146-22
Standard Specification for Forged Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
ASTM F2633-19
Standard Specification for Forged Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM F2989-21
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
ASTM F3046-21
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)
ASTM F1314-18
Standard Specification for Forged Nitrogen-Reinforced 22 Chromium–13 Nickel–5 Manganese–2,5 Molybdenum Stainless Steel Alloy Rod and Wire for Surgical Implants (UNS S20910)
ASTM F560-17
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
ASTM F1586-21
Standard Specification for Forged Nitrogen-Reinforced 21Chrome - 10Nickel - 3Manganese - 2.5Molybdenum Stainless Steel Alloy Rod for Surgical Implants (UNS S31675)
ASTM F2066-18
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
ASTM F138-19
Standard Specification for Forged 18Chrome-14Nickel-2.5Molybdenum Stainless Steel Rod and Wire for Surgical Implants (UNS S31673)
ASTM F899-20
Standard Specification for Forged Stainless Steels for Surgical Instruments
ASTM F75-18
Standard Specification for Casting Alloy for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Surgical Implants (UNS R30075)
ASTM F139-19
Standard Specification for Forged 18Chrome-14Nickel-2.5Molybdenum Stainless Steel Plate and Strip for Surgical Implants (UNS S31673)
ASTM F621-12(2021)e1
Standard Specification for Stainless Steel Forgings for Surgical Implants
ASTM F1091-20
Standard Specification for Wrought Cobalt-20Chrome-15Tungsten-10Nickel-Alloy Surgical Fixation Wire (UNS R30605)
ASTM F1580-18
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
ASTM F2063-18
Standard Specification for Forged Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2229-21
Standard Specification for Forged, Nitrogen-Reinforced 23Manganese-21Chromium-1Molybdenum Low Nickel Stainless Steel Alloy Rod and Wire for Surgical Implants (UNS S29108)
ASTM F2581-12 (2017)
Standard Specification for Forged Nitrogen-Reinforced 11Manganese-17Chromium-3Molybdenum Low Nickel Stainless Steel Alloy Rod and Wire for Surgical Implants (UNS S29225)
ASTM F799-19
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
ASTM F1295-16
Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
ASTM F1537-20
Standard Specification for Forged Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM F2885-17
Standard Specification for Metal Injection-Moulded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
ASTM F1089-18
Standard Test Method for Corrosion of Surgical Instruments
ASTM F2384-10 (2016)
Standard Specification for Forged Zirconium-2.5 Niobium Alloy for Surgical Implant Applications (UNS R60901)
ASTM F2527-16
Standard Specification for Forged Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubes for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
ASTM F2886-17
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
ASTM F1058-16
Standard Specification for Forged 40Cobalt-20Chrome-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
Neurosurgery Standards
ASTM F452-76 (2014)
Standard Specification for Preformed Cranioplasty Plates
ASTM F647-94 (2014)
Standard Practice for Evaluation and Determination of Implantable Shunt Groups for Neurosurgery Practice
ASTM F700-93 (2014)
Standard Practice for the Care and Use of Intracranial Aneurysm Clips and Instruments
ASTM F1831-17
Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
ASTM F701-81 (2008)
Standard Practice for the Care and Use of Neurosurgical Implants and Instruments
ASTM F982-86 (2008)
Standard Specification for the Characteristics of Surgically Implanted Clamps for Carotid Occlusion
ASTM F1266-89 (2008)
Standard Performance Specification for Cerebral Stereotactic Instruments
ASTM F1719-96 (2008)
Standard Specification for Image-Interactive Stereotactic and Localization Systems
Osteosynthesis
ASTM F366-17
Standard Specification for Fixing Pins and Wires
ASTM F564-17
Standard Specification and Test Methods for Metallic Bone Staples
ASTM F1541-17
Standard Specification and Test Methods for Exoskeleton Detection Devices
ASTM F2180-17
Standard Specification for Metallic Implantable Wires and Cables
ASTM F382-17
Standard Specification and Test Method for Metallic Bone Plates
ASTM F1264-16e1
Standard Specification and Test Methods for Intramedullary Fixation Devices
ASTM F565-21
Standard Practice for the Care and Use of Orthopedic Implants and Instruments
ASTM F983-86 (2018)
Standard Practice for Permanent Marking of Orthopedic Implant Components
ASTM F1611-20
Standard Specification for Intramedullary Reamers
ASTM F543-17
Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F116-12 (2021)
Standard Specification for Medical Screwdriver Bits
ASTM F384-17
Standard Specifications and Test Methods for Metallic Angle Orthopedic Fracture Detectors
ASTM F1839-08 (2021)
Standard Specification for Rigid Polyurethane Foam for Use as Standard Material for Testing Orthopedic Devices and Appliances
ASTM F2502-17
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Plastic and Reconstructive Surgery
ASTM F881-94 (2014)
Standard Specification for Silicone Elastomer Facial Implants
ASTM F1441-03 (2014)
Standard Specification for Soft Tissue Extender Devices
ASTM F2051-00 (2014)
Standard Specification for Implantable Saline-Filled Breast Prosthesis
Polymeric Materials
ASTM F2848-21
Standard Specification for Medical-Grade Ultra High Molecular Weight Polyethylene Yarns
ASTM F624-09(2015)e1
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
ASTM F602-09 (2015)
Standard Criteria for Implantable Thermoset Epoxy Plastics
ASTM F639-09 (2015)
Standard Specification for Polyethylene Plastics for Medical Applications
ASTM F665-09 (2015)
Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F754-08 (2015)
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Manufactured from Granular Molding Powders
ASTM F3087-15
Standard Specification for Acrylic Molding Resins for Medical Implant Applications
ASTM F641-09 (2014)
Standard Specification for Implantable Epoxy Electronic Encapsulants
ASTM F648-21
Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Manufactured Form for Surgical Implants
ASTM F2026-17
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
ASTM F2565-21
Standard Guide for Forms Made of Comprehensive Irradiation Crosslinked Ultra High Molecular Weight Polyethylene for Surgical Implant Applications
ASTM F2695-12 (2020)
Standard Specification for Ultra High Molecular Weight Polyethylene Powder Blended with Alpha-Tocopherol (Vitamin E) and Forms Manufactured for Surgical Implant Applications
ASTM F2820-12(2021)e1
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
ASTM F2902-16e1
Standard Guide for Evaluation of Absorbable Polymeric Implants
ASTM F755-19
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
ASTM F1855-00 (2019)
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
ASTM F2038-18
Standard Guidelines for Silicone Elastomers, Gels, and Foams for Medical Applications Part I—Formulations and Uncured Materials
ASTM F2042-18
Standard Guidelines for Silicone Elastomers, Gels, and Foams for Medical Applications Part II—Crosslinking and Manufacturing
ASTM F2759-19
Standard Guide for Evaluation of Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F702-18
Standard Specification for Polysulfone Resin for Medical Applications
ASTM F997-18
Standard Specification for Polycarbonate Resin for Medical Applications
ASTM F2313-18
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with a Fraction greater than or equal to 70% Glycolide
ASTM F2579-18
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
ASTM F1925-17
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
ASTM F451-21
Standard Specification for Acrylic Bone Cement
Spine Devices
ASTM F1717-21
Standard Test Methods for Spine Implant Structures in the Vertebrectomy Model
ASTM F2789-10 (2020)
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
ASTM F2077-18
Test Methods for Intervertebral Body Fusion Devices
ASTM F2193-20
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F2706-18
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Structures in a Vertebrectomy Model
ASTM F2790-10(2019)e1
Standard Practice for Static and Dynamic Characterization of Motion-Sparing Lumbar Total Facet Prosthesis
ASTM F1798-21
Standard Test Method for Evaluation of Static and Fatigue Properties of Interconnect Mechanisms and Sub-Assemblies Used in Spinal Arthrodesis Implants
ASTM F2694-16 (2020)
Standard Practice for Functional and Wear Evaluation of Mobility-Retaining Lumbar Total Facet Prostheses
ASTM F2624-12 (2020)
Standard Test Method for Static, Dynamic, and Abrasion Evaluation of Extra-Discal Unilevel Spinal Structures
ASTM F1582-98 (2016)
Standard Terminology for Spinal Implants
ASTM F2267-04 (2018)
Standard Test Method for Measuring Load-Induced Insertion of an Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F2346-18
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
ASTM F2423-11 (2020)
Standard Guide for the Functional, Kinematic, and Wear Evaluation of Total Disk Prostheses
Urological Materials and Devices
ASTM F1828-17
Standard Specification for Ureteral Stents
ASTM F623-19
Standard Performance Specification for Foley Catheter
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