ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipments. These apparatuses are used in surgical procedures that involve the placement of such devices to specified parts and structures of the body (both humans and animals) for the purpose of enhancement or as an aid in a disability. These medical device and implant standards allow material and product manufacturers, medical laboratories, and other concerned institutions to inspect and assess such instruments to ensure proper quality and workmanship.
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Arthroplasty
F2582-20 Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
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
F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
F3090-20 Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
F3334-19 Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
F370-94(1999) Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
F2083-21 Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
F2091-15 Standard Specification for Acetabular Prostheses (Withdrawn 2023)
F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
F2665-21 Standard Specification for Total Ankle Replacement Prosthesis
F2724-21 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
F2722-21 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
F2723-21 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
F3129-16 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
F2025-06(2018) Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
F1714-96(2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F2580-18 Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
F1378-18e1 Standard Specification for Shoulder Prostheses
F1672-14(2019) Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
F2943-14(2019) Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
F2385-15(2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
F1800-19e1 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
F1612-95(2005) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion (Withdrawn 2011)
F1440-92(2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion (Withdrawn 2012)
F1636-95e2 Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)
F1715-00e1 Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)
F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
F3210-22e1 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
F1875-98(2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
F1357-23 Standard Specification for Articulating Total Wrist Implants
F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
F2887-23 Standard Specification for Total Elbow Prostheses
F3141-23 Standard Guide for Total Knee Replacement Loading Profiles
F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
F3495-23 Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
F2777-23 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
F3161-24 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
F2996-24 Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
Assessment for TEMPs
F2529-13(2021) Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
F3223-17 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
F3207-17 Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
F3224-17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
F2903-11 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
F2451-05(2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
F2884-21 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
F3225-17(2022) Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
F2721-09(2023) Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects
Biocompatibility Test Methods
F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
F2151-01 Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007)
F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F895-11(2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F2147-01(2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
F1877-16 Standard Practice for Characterization of Particles
F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
E1262-88(2018) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
F1984-99(2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
F1439-03(2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
F2888-19 Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
E1280-97(2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity (Withdrawn 2015)
E1202-87(2008) Standard Guide for Development of Micronucleus Assay Standards (Withdrawn 2013)
E1397-91(2008) Standard Practice for In Vitro Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)
E1398-91(2008) Standard Practice for In Vivo Rat Hepatocyte DNA Repair Assay (Withdrawn 2014)
E1263-97(2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes (Withdrawn 2015)
F2567-06(2010) Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
F2065-00(2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)
F1905-98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
F719-20e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
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
F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F2382-24 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
Biomaterials and Biomolecules for TEMPs
F3354-19 Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
F3274-21 Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
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)
F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
F3510-21 Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
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)
F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
F3142-16 Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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
F3259-17 Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
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
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)
F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
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)
F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
F2603-06(2020) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
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
F2952-22 Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
F3089-23 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
F2791-24 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
F3659-24 Standard Guide for Bioinks Used in Bioprinting
Cardiovascular Standards
F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
F1841-19e1 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
F3067-14(2021) Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
F2606-08(2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
F3172-15(2021) Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
F3211-17 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses
F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
F3036-21 Standard Guide for Testing Absorbable Stents
F2079-09(2022) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
F2081-06(2022) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
F2394-07(2022) Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System
F2914-12(2024) Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
F3575-24 Standard Guide for Model Development for Particulate Generation Testing of Endovascular Devices
F2477-24 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
F3320-18(2024) Standard Guide for Coating Characterization of Drug-Coated Balloons
F2743-11(2024) Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
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
F2739-19 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
F3209-16 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
F2386-04 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
F2997-21 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
F2149-16 Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
F2664-19e1 Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
F3369-19e1 Standard Guide for Assessing the Skeletal Myoblast Phenotype
F2210-02(2010) Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
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
F3504-21 Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
F3106-22 Standard Guide for in vitro Osteoblast Differentiation Assays
F3088-22 Standard Practice for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
F3570-22 Standard Terminology Relating to Microphysiological Systems
Ceramic Materials
F1926/F1926M-14(2021) Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
F1658-95 Test Method for Shear Testing of Calcium Phosphate Coatings (Withdrawn 2000)
F1659-95 Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates (Withdrawn 2005)
F1501-95 Test Method for Tension Testing of Calcium Phosphate Coatings (Withdrawn 2000)
F1873-98 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)
F603-12(2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F2393-12(2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
F1581-08(2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
F2224-09(2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
F2024-10(2021) Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
F1088-23 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
F1185-23 Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
F1538-24 Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation
Classification and Terminology for TEMPs
F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)
F2312-11(2020) Standard Terminology Relating to Tissue Engineered Medical Products
F2311-08 Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
F3163-22 Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
Computer Assisted Orthopedic Surgical Systems
F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
F3107-14(2023) Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
Consumer Rubber Products
D3772-15(2021) Standard Specification for Industrial Rubber Finger Cots
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)
D8389-21 Standard Performance Specification for Urinary Intermittent Catheters
D6976-13(2018) Standard Specification for Rubber Contraceptives—Vaginal Diaphragms
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
D7907-14(2019) Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
F623-19 Standard Performance Specification for Foley Catheter
D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)
D4679-21 Standard Specification for Rubber General Purpose, Household or Beautician Gloves
D8419-21 Standard Specification for Anesthesia Reservoir Bags
D7246-06(2021) Standard Test Method for Detection of Holes in Polyethylene Food Service Gloves
D6355-07(2022) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
D7102-17(2022) Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
D3899-93e2 Standard Specification for Rubber Contraceptives-Vaginal Diaphragms (Withdrawn 2002)
D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
D3579-77(2023) Standard Specification for Rubber Surgical Drainage Tubes, Penrose-Type
D6324-11(2023) Standard Specification for Male Condoms Made from Polyurethane
D7160-16(2023) Standard Practice for Determination of Expiration Dating for Medical Gloves
D7161-16(2023) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
D7198-05(2023) Standard Specification for Disposable Embalming Gloves for Single-Use Applications
D6284-17(2023) Standard Test Method for Rubber Property—Effect of Aqueous Solutions with Available Chlorine and Chloramine
D3577-19(2023) Standard Specification for Rubber Surgical Gloves
D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
D3578-19(2023) Standard Specification for Rubber Examination Gloves
D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
D6978-05(2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
D7103-19(2023) Standard Guide for Assessment of Medical Gloves
D7661-23 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
D4316-95(2023) Standard Specification for Elastomeric Water Bottles
D7850-24 Standard Specification for Biological Properties of Industry Reference Materials (IRM)
D6499-24 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
D8238-24 Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins
D7329-07(2024) Standard Specification for Food Preparation and Food Handling (Food Service) Gloves
GI Applications
F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera (Withdrawn 2009)
F1992-99(2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)
F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Human Clinical Trials
F3108-19 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
F3037-15 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
F3448-20 Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
Implantable Hearing Devices (IHDs)
F2504-05(2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
Material Test Methods
F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
F3487-20 Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
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
F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024)
F2255-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
F2392-04(2015) Standard Test Method for Burst Strength of Surgical Sealants
F2258-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
F2256-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
F2458-05(2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
F1634-95(2016) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017)
F746-04(2021) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
F1044-05(2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
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
F1089-18 Standard Test Method for Corrosion of Surgical Instruments
F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
F3335-20 Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix, and Direction of Helix of Coiled Wire
F2183-02(2008) Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
F2118-14(2020) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
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)
F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
F1536-95(2015)e1 Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape (Withdrawn 2021)
F3268-18a Standard Guide for in vitro Degradation Testing of Absorbable Metals
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
F3336-22 Standard Practice for Lipid Preconditioning of Ultra-High-Molecular-Weight Polyethylene for Accelerated Aging
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
F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
F2516-22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
F1978-22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
F3127-22 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
F640-23 Standard Test Methods for Determining Radiopacity for Medical Use
F3109-23 Standard Practice for Verification of Multi-Axis Force Measuring Platforms
F3602-23 Standard Guide for Assessing the Compatibility of a Cleaning Brush Part with Different Substrates Used in the Construction of Medical Devices
F2214-23 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
F2082/F2082M-23 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
F2503-23e1 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
F2995-24 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
F3438-24 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
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
F1147-24 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F2119-24 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2004-24 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
F2819-24 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing, and Wire to be Used for Medical Devices
Medical/Surgical Instruments
F3014-14 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures (Withdrawn 2023)
F1744-96(2016) Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
E667-98(2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers (Withdrawn 2022)
E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
F2062-00(2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
F1078-10(2018) Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
F921-10(2018) Standard Terminology Relating to Hemostatic Forceps
F882-84(2002) Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
F1874-98(2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures (Withdrawn 2020)
F2132-01(2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps (Withdrawn 2017)
E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
F1026-86(2022) Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
F1079-87(2022) Standard Specification for Inserted and Noninserted Surgical Scissors
F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
F1613-95(2023) Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
F1638-95(2023) Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
F1840-10(2023) Standard Terminology for Surgical Suture Needles
E825-98(2023) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
E1104-98(2023) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
E1299-96(2023) Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature
E1965-98(2023) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
F1325-91(2023) Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
Metallurgical Materials
F563-00 Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
F2229-21 Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F1341-99 Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications (Withdrawn 2006)
F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
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)
F621-12(2021)e1 Standard Specification for Stainless Steel Forgings for Surgical Implants
F136-13(2021)e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F67-13(2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
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)
F1813-21 Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
F1580-18 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F139-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
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)
F2181-20 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
F3046-21 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical Implant Applications (UNS R56320)
F3273-17(2021)e1 Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
F2989-21 Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
F1713-08(2021)e1 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F2146-22 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
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)
F1472-23 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F2885-17(2023) Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
F90-23 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F2066-23 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
F75-23 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F2886-17(2023) Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F899-23 Standard Specification for Wrought Stainless Steels for Surgical Instruments
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)
F1295-24 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
F1350-24 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
F2384-24 Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
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
F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)
F1831-17 Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
F1266-89(2008) Standard Performance Specification for Cerebral Stereotactic Instruments (Withdrawn 2017)
F982-86(2008) Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
F622-79(2002) Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
F1719-96(2008) Standard Specification for Image-Interactive Stereotactic and Localization Systems (Withdrawn 2017)
F701-81(2008) Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017)
F700-93(2022) Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
F647-22 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
F452-76(2022) Standard Specification for Preformed Cranioplasty Plates
Osteosynthesis
F117-95(1999)e1 Test Method for Driving Torque of Medical Bone Screws (Withdrawn 2001)
F1028-86(1991) Specification for Tri-Fin Nails (Withdrawn 1996)
F1622-95(2000) Test Method for Measuring the Torsional Properties of Metallic Bone Screws (Withdrawn 2001)
F1745-96 Test Method for External Fixator Connectors (Withdrawn 2000)
F1746-96 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements (Withdrawn 2000)
F1747-96 Test Method for External Fixator Joints (Withdrawn 2000)
F1748-96 Test Method for External Fixator Subassemblies (Withdrawn 2000)
F1539-95(1999) Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples (Withdrawn 2000)
F1691-96 Test Method for Determining Axial Pull-Out Strength of Medical Bone Screws (Withdrawn 2001)
F1540-95(1999) Test Method for Pull-Out Fixation Strength of Metallic Bone Staples (Withdrawn 2000)
F1660-95(1999) Test Method for Elastic Static Bending of Metallic Bone Staples (Withdrawn 2000)
F1610-95(1999) Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples (Withdrawn 2000)
F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F2180-17 Standard Specification for Metallic Implantable Strands and Cables
F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
F564-17 Standard Specification and Test Methods for Metallic Bone Staples
F983-86(2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
F1611-20 Standard Specification for Intramedullary Reamers
F116-12(2021) Standard Specification for Medical Screwdriver Bits
F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
F787-82(1991) Specification for Metallic Nail-Plate Appliances (Withdrawn 1998)
F367-81(1991) Specification for Holes and Slots for Inch Cortical Bone Screws (Withdrawn 1997)
F544-92 Reference Chart for Pictorial Cortical Bone Screw Classification (Withdrawn 1998)
F3437-23 Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
F543-23 Standard Specification and Test Methods for Metallic Medical Bone Screws
F366-24 Standard Specification for Fixation Pins and Wires
F382-24 Standard Specification and Test Method for Metallic Bone Plates
F384-24 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
F1264-24 Standard Specification and Test Methods for Intramedullary Fixation Devices
F1541-24 Standard Specification and Test Methods for External Skeletal Fixation Devices
Plastic and Reconstructive Surgery
F703-18(2022) Standard Specification for Implantable Breast Prostheses
F881-94(2022) Standard Specification for Silicone Elastomer Facial Implants
F1441-03(2022) Standard Specification for Soft-Tissue Expander Devices
F2051-00(2022) Standard Specification for Implantable Saline-Filled Breast Prostheses
Polymeric Materials
F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
F754-08(2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
F604-94 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
F624-09(2015)e1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
F665-09(2015) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
F602-09(2015) Standard Criteria for Implantable Thermoset Epoxy Plastics (Withdrawn 2024)
F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications
F451-21 Standard Specification for Acrylic Bone Cement
F2902-16e1 Standard Guide for Assessment of Absorbable Polymeric Implants
F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
F702-18 Standard Specification for Polysulfone Resin for Medical Applications
F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
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
F1855-00(2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
F2759-19 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
F1579-02e1 Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)
F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
F1876-98(2003)e1 Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn 2012)
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
F3384-21 Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
F641-09(2023) Standard Specification for Implantable Epoxy Electronic Encapsulants
F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
F639-09(2024) Standard Specification for Polyethylene Plastics for Medical Applications
Spinal Devices
F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1582-98(2016) Standard Terminology Relating to Spinal Implants
F2706-18 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
F3295-18 Standard Guide for Impingement Testing of Total Disc Prostheses
F3292-19 Standard Practice for Inspection of Spinal Implants Undergoing Testing
F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices
F2790-10(2019)e1 Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
F2789-10(2020) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
F2694-16(2020) Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
F2624-12(2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
F2423-11(2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
F3574-22 Standard Test Methods for Sacroiliac Joint Fusion Devices
F2077-22 Standard Test Methods for Intervertebral Body Fusion Devices
F3631-24 Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
F2267-24 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Urological Materials and Devices
F1828-22 Standard Specification for Ureteral Stents
