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ASTM Medical Device Standards

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards.

 Medical/Surgical Instruments
 Adventitious Agents Safety
 Arthroplasty
 Assessment for TEMPs
 Biocompatibility Test Methods
 Biomaterials and Biomolecules for TEMPs
 Cardiovascular Standards
 Cell Signaling
 Cells and Tissue Engineered Constructs for TEMPs
 Ceramic Materials
 Classification and Terminology for TEMPs
 Computer Assisted Orthopaedic Surgical Systems
 Editorial and Terminology
 GI Applications
 Human Clinical Trials
 Implantable Hearing Devices (IHDs)
 Material Test Methods
 Metallurgical Materials
 Neurosurgical Standards
 Osteosynthesis
 Plastic and Reconstructive Surgery
 Polymeric Materials
 Spinal Devices
 Urological Materials and Devices

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-Reading Liquid Crystal Forehead Thermometers

ASTM F1026-86(2014)

Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

ASTM F1079-87(2014)

Standard Specification for Inserted and Noninserted 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 Relating to Hemostatic Forceps

ASTM F1078-10(2018)

Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades

ASTM F1874-98(2011)

Standard Test Method for Bend Testing of Needles Used in Surgical Sutures

ASTM F2062-00(2018)

Standard Specification for Square Drive Interconnections on Surgical Instruments

ASTM E1299-96(2016)

Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature

ASTM E667-98(2017)

Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

ASTM E825-98(2016)

Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature

ASTM E1104-98(2016)

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

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 Suture Needle Holders-General Workmanship 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/Dressing/Pick-Up Forceps (Thumb-Type)

ASTM F1744-96(2016)

Standard Guide for Care and Handling 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

Adventitious Agents Safety

ASTM F2383-11

Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

Arthroplasty

ASTM F3161-16

Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions

ASTM F1781-21

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

ASTM F1814-15

Standard Guide for 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 Acetabular Components of Total Hip Replacement Using Clinical Radiographs

ASTM F2722-21

Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops

ASTM F3047M-15

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

ASTM F3141-17a

Standard Guide for Total Knee Replacement Loading Profiles

ASTM F1223-20

Standard Test Method for Determination of Total Knee Replacement Constraint

ASTM F1357-14(2019)

Standard Specification for Articulating Total Wrist Implants

ASTM F1672-14(2019)

Standard Specification for Resurfacing Patellar Prosthesis

ASTM F2028-17

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

ASTM F2582-20

Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components

ASTM F2943-14(2019)

Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

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 F2665-21

Standard Specification for Total Ankle Replacement Prosthesis

ASTM F2724-21

Standard Test Method for Evaluating Mobile Bearing Knee Dislocation

ASTM F1820-13

Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

ASTM F2580-18

Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

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 F2996-20

Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

ASTM F1714-96(2018)

Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices

ASTM F2345-21

Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

ASTM F2723-21

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation

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 Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

ASTM F2083-21

Standard Specification for 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 Assessment

ASTM F2009-20

Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

ASTM F2777-16

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

ASTM F1829-17

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

Assessment for TEMPs

ASTM F2721-09(2014)

Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects

ASTM F2529-13(2021)

Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)

ASTM F2884-12

Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

ASTM F2903-11

Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair

ASTM F2451-05(2010)

Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

Biocompatibility Test Methods

ASTM F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

ASTM F1904-14

Standard Practice for Testing the Biological Responses to Particles in vivo

ASTM F1983-14

Standard Practice for Assessment of 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 Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

ASTM F749-20

Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

ASTM F756-17

Standard Practice for Assessment of Hemolytic Properties of Materials

ASTM F1408-20a

Standard Practice for Subcutaneous Screening Test for Implant Materials

ASTM F1439-03(2018)

Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

ASTM F1984-99(2018)

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

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 F719-20e1

Standard Practice for Testing Materials 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 Assessment of 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 Generic 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 Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

ASTM F1877-16

Standard Practice for Characterization of Particles

ASTM F1903-18

Standard Practice for Testing for Cellular Responses to Particles in vitro

ASTM F2147-01(2016)

Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

ASTM F2382-18

Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

ASTM F2808-17

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

Biomaterials and Biomolecules for TEMPs

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 F2791-15

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

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 F2952-14

Standard Guide for Determining the Mean 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 Regenerative Medicine and Tissue-Engineered Medical Products

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-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line

ASTM F2603-06(2020)

Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds

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

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 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 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

ASTM F2900-11

Standard Guide for Characterization of Hydrogels used in Regenerative Medicine

ASTM F2450-18

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered 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)

Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

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

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F3036-21

Standard Guide for Testing Absorbable Stents

ASTM F1830-19

Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps

ASTM F1841-19e1

Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

ASTM F2079-09(2017)

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM F2081-06(2017)

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM F2394-07(2017)

Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM F2477-19

Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2914-12(2018)

Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

ASTM F2743-11(2018)

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

Cell Signaling

ASTM F2998-14

Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells

Cells and Tissue Engineered Constructs for TEMPs

ASTM F3088-14

Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions

ASTM F3106-14

Standard Guide for in vitro Osteoblast Differentiation Assays

ASTM F2997-21

Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis

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 F2315-18

Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

ASTM F2664-19e1

Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods

ASTM F2739-19

Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds

ASTM F2149-16

Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions

Ceramic Materials

ASTM F1926/F1926M-14(2021)

Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

ASTM F1185-03(2014)

Standard Specification for Composition of Hydroxylapatite 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 Dense Aluminum Oxide for Medical Application

ASTM F1581-08(2020)

Standard Specification for Composition of Anorganic Bone for Surgical Implants

ASTM F2393-12(2020)

Standard Specification for High-Purity Dense 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-Sprayed 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 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

Computer Assisted Orthopaedic Surgical Systems

ASTM F3107-14

Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

ASTM F2554-18

Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

Editorial and Terminology

ASTM F2809-10

Standard Terminology Relating to Medical and Surgical Materials and Devices

GI Applications

ASTM F2528-06(2014)

Standard Test Methods for Enteral Feeding Devices with a Retention Balloon

ASTM F1992-99(2007)

Standard Practice for Reprocessing of Reusable, Heat-Stable 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 Devices (IHDs)

ASTM F2504-05(2014)

Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

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 on Medical Devices in the Magnetic Resonance Environment

ASTM F2082/F2082M-16

Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

ASTM F2129-19a

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

ASTM F1536-95(2015)e1

Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic 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 Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading

ASTM F2256-05(2015)

Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

ASTM F2258-05(2015)

Standard Test Method for Strength Properties of Tissue Adhesives in Tension

ASTM F2392-04(2015)

Standard Test Method for Burst 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 Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)

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 F746-04(2021)

Standard Test Method for Pitting or Crevice 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 Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

ASTM F2118-14(2020)

Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

ASTM F2516-18

Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

ASTM F3044-20

Standard Test Method for Evaluating the Potential for Galvanic Corrosion 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 Fretting Corrosion of Osteosynthesis Plates and Screws

ASTM F2102-17

Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended 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 the Magnetic Resonance Environment

ASTM F2754/F2754M-21

Standard Test Method for Measurement of Camber, Cast, Helix, and Direction of Helix of Coiled Wire

ASTM F2977-20

Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

ASTM F2995-16

Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids

ASTM F640-20

Standard Test Methods for Determining Radiopacity for Medical Use

ASTM F1978-18

Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

ASTM F2459-18

Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

ASTM F2182-19e2

Standard Test Method for 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 Wear 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

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

ASTM F2213-17

Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F2537-06(2017)

Standard Practice for Calibration of 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 Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

ASTM F2625-10(2016)

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 F2847-17

Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile 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

Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

Metallurgical Materials

ASTM F629-20

Standard Practice for Radiography of Cast Metallic Surgical Implants

ASTM F1350-15

Standard Specification for Wrought 18Chromium-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 the Alpha Plus Beta Condition

ASTM F90-14

Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

ASTM F688-19

Standard Specification for Wrought Cobalt-35Nickel-20Chromium-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 Wrought Seamless Stainless Steel Tubing for Surgical Implants

ASTM F2257-14

Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for 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 Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F562-22

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

ASTM F601-18

Standard Practice for Fluorescent Penetrant Inspection 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 Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

ASTM F1813-21

Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)

ASTM F2146-22

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

ASTM F2633-19

Standard Specification for Wrought 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 Wrought Nitrogen Strengthened 22 Chromium–13 Nickel–5 Manganese–2.5 Molybdenum Stainless Steel Alloy Bar 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 Wrought Nitrogen Strengthened 21Chromium - 10Nickel - 3Manganese - 2.5Molybdenum Stainless Steel Alloy Bar 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 Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

ASTM F899-20

Standard Specification for Wrought Stainless Steels for Surgical Instruments

ASTM F75-18

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

ASTM F139-19

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet 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-20Chromium-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 Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

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 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 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 Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

ASTM F2885-17

Standard Specification for Metal Injection Molded 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 Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

ASTM F2527-16

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 F2886-17

Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

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)

Neurosurgical Standards

ASTM F452-76(2014)

Standard Specification for Preformed Cranioplasty Plates

ASTM F647-94(2014)

Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

ASTM F700-93(2014)

Standard Practice for Care and Handling 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 Care and Handling of Neurosurgical Implants and Instruments

ASTM F982-86(2008)

Standard Specification for Disclosure of 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 Fixation Pins and Wires

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 F2180-17

Standard Specification for Metallic Implantable Strands 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 Care and Handling of Orthopedic Implants and Instruments

ASTM F983-86(2018)

Standard Practice for Permanent Marking of Orthopaedic 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 Angled Orthopedic Fracture Fixation Devices

ASTM F1839-08(2021)

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

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 Expander 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 Fabricated 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 Fabricated Form for Surgical Implants

ASTM F2026-17

Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

ASTM F2565-21

Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

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 F2820-12(2021)e1

Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

ASTM F2902-16e1

Standard Guide for Assessment 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 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

ASTM F2042-18

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

ASTM F2759-19

Standard Guide for Assessment of the 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 Mole Fractions 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

Spinal Devices

ASTM F1717-21

Standard Test Methods for Spinal Implant Constructs in a 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 Constructs in a Vertebrectomy Model

ASTM F2790-10(2019)e1

Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

ASTM F1798-21

Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

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 F1582-98(2016)

Standard Terminology Relating to Spinal Implants

ASTM F2267-04(2018)

Standard Test Method for Measuring Load Induced Subsidence of 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 Functional, Kinematic, and Wear Assessment of Total Disc 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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