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.

Medical Device Standards and Implant Standards

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.

Jump to:

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

F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

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

F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

F1875-98(2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

F2091-15 Standard Specification for Acetabular Prostheses

F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants

F3161-16 Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions

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

F2777-16 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

F2887-17 Standard Specification for Total Elbow 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

F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

F3141-17a Standard Guide for Total Knee Replacement Loading Profiles

F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

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

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

F1357-14(2019) Standard Specification for Articulating Total Wrist Implants

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

Assessment for TEMPs

F2721-09(2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects

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)

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)

F1983-14 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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

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

F1904-14 Standard Practice for Testing the Biological Responses to Particles in vivo

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

F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

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

F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

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

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)

F3089-14 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

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)

F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

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

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

F2477-19 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

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

F2081-06(2017) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

F2079-09(2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

F2394-07(2017) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

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

F3320-18 Standard Guide for Coating Characterization of Drug Coated Balloons

F2743-11(2018) Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

F2914-12(2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

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

Cell Signaling

F2998-14 Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells

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

F1609-08(2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials

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)

F1538-03(2017) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

F1185-03(2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants

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

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

F3107-14 Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

Consumer Rubber Products

D7103-19 Standard Guide for Assessment of Medical Gloves

D3772-15(2021) Standard Specification for Industrial Rubber Finger Cots

D7866-14a Standard Specification for Radiation Attenuating Protective Gloves

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

D8389-21 Standard Performance Specification for Urinary Intermittent Catheters

D7161-16 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

D4316-95(2016) Standard Specification for Elastomeric Water Bottles

D3579-77(2016) Standard Specification for Rubber Surgical Drainage Tubes, Penrose-Type

D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves

D6284-17 Standard Test Method for Rubber Property—Effect of Aqueous Solutions with Available Chlorine and Chloramine

D6324-11(2017) Standard Specification for Male Condoms Made from Polyurethane

D7198-05(2018) Standard Specification for Disposable Embalming Gloves for Single-Use Applications

D7329-07(2018) Standard Specification for Food Preparation and Food Handling (Food Service) Gloves

D6499-18 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products

D6976-13(2018) Standard Specification for Rubber Contraceptives—Vaginal Diaphragms

D8238-18 Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins

D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

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

D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application

D5151-19 Standard Test Method for Detection of Holes in Medical Gloves

D3577-19 Standard Specification for Rubber Surgical Gloves

D7850-19 Standard Specification for Biological Properties of Industry Reference Materials (IRM)

D3578-19 Standard Specification for Rubber Examination Gloves

D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application

D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method

D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

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

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(2014) 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)

Implantable Hearing Devices (IHDs)

F2504-05(2014) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices

Material Test Methods

F2214-16 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

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

F2255-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading

F2003-02(2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

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

F3438-21 Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices

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

F3127-16 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

F1634-95(2016) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017)

F3109-16 Standard Test Method for Verification of Multi-Axis Force Measuring Platforms

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

F2995-16 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids

F1147-05(2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

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

F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

F2819-10(2015)e2 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices

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

F2537-06(2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion

F3260-18 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles

F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

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

F2082/F2082M-16 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

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

F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

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)

F2119-07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (Withdrawn 2022)

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

F640-20 Standard Test Methods for Determining Radiopacity for Medical Use

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

F3602-22 Standard Guide for Assessing the Compatibility of a Cleaning Brush Part with Different Substrates Used in the Construction of Medical Devices

Medical/Surgical Instruments

F3014-14 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures

E1965-98(2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

E1299-96(2016) Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature

F3212-16 Standard Test Method for Coring Testing of Huber Needles

E825-98(2016) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature

F1613-95(2016) Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

F1325-91(2016) Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods

F1840-10(2016) Standard Terminology for Surgical Suture Needles

F1744-96(2016) Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

F1638-95(2016)e1 Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

E667-98(2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers

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

E1104-98(2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths

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

Metallurgical Materials

F1472-20a Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

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

F90-14 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

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)

F1350-15 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

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)

F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants

F2384-10(2016) Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys

F1295-16 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

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)

F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

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)

F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

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)

F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

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

F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments

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)

Neurosurgical Standards

F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)

F452-76(2014) Standard Specification for Preformed Cranioplasty Plates

F647-94(2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

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

Osteosynthesis

F382-17 Standard Specification and Test Method for Metallic Bone Plates

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

F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices

F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws

F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

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

F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices

F366-17 Standard Specification for Fixation Pins and Wires

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

Plastic and Reconstructive Surgery

F2051-00(2014) Standard Specification for Implantable Saline Filled Breast Prosthesis

F703-18 Standard Specification for Implantable Breast Prostheses

F881-94(2014) Standard Specification for Silicone Elastomer Facial Implants

F1441-03(2014) Standard Specification for Soft-Tissue Expander Devices

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

F641-09(2014) Standard Specification for Implantable Epoxy Electronic Encapsulants

F639-09(2015) Standard Specification for Polyethylene Plastics for Medical 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

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

F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

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

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

F2267-22 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Urological Materials and Devices

F1828-17 Standard Specification for Ureteral Stents