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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.
List of medical device standards and implant standards developed by ASTM:

Adventitious Agents Safety
Designation Title
F2383 - 11
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products
(TEMPs)
Arthroplasty
Designation Title
F1223 - 08(2012) Standard Test Method for Determination of Total Knee Replacement Constraint
F1357 - 09 Standard Specification for Articulating Total Wrist Implants
F1378 - 12 Standard Specification for Shoulder Prostheses
F1672 - 95(2011) Standard Specification for Resurfacing Patellar Prosthesis
F1714 - 96(2013)
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator
Devices
F1781 - 03(2009) Standard Specification for Elastomeric Flexible Hinge Finger Total J oint Implants
F1800 - 12
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total
Knee J oint Replacements
F1814 - 97a(2009) Standard Guide for Evaluating Modular Hip and Knee J oint Components
F1820 - 13
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular
Devices
F1829 - 98(2009) Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
F2009 - 00(2011)
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections
of Modular Prostheses
F2025 - 06(2012)
Standard Practice for Gravimetric Measurement of Polymeric Components for Wear
Assessment
F2028 -
08(2012)e1
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
F2033 - 12
Standard Specification for Total Hip J oint Prosthesis and Hip Endoprosthesis Bearing
Surfaces Made of Metallic, Ceramic, and Polymeric Materials
F2068 - 09 Standard Specification for Femoral Prostheses—Metallic Implants
F2083 - 12 Standard Specification for Knee Replacement Prosthesis
F2091 - 01(2012) Standard Specification for Acetabular Prostheses
Designation Title
F2345 - 03(2013)
Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic
Modular Femoral Heads
F2385 - 04(2010)
Standard Test Method for Determining Femoral Head Penetration into Acetabular
Components of Total Hip Replacement Using Clinical Radiographs
F2580 - 13
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip
Prosthesis
F2582 - 08 Standard Test Method for Impingement of Acetabular Prostheses
F2665 - 09 Standard Specification for Total Ankle Replacement Prosthesis
F2722 - 08
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational
Stops
F2723 - 13a
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing
Resistance to Dynamic Disassociation
F2724 - 08 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
F2777 - 10
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and
Deformation Under High Flexion
F2887 - 12 Standard Specification for Total Elbow Prostheses
F2943 - 13
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants
Used in J oint Arthroplasty
F2996 - 13
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic
Hip Femoral Stems
Assessment for TEMPs
Designation Title
F2451 - 05(2010)
Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or
Regenerate Articular Cartilage
F2529 - 13
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing
Demineralized Bone (DBM)
F2721 - 09 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
F2884 - 12 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
F2903 - 11
Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of
Tendon and Ligament Surgical Repair
Biocompatibility Test Methods
Designation Title
E1262 -
88(2013)
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation Assay
E1263 -
97(2008)
Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow
Erythrocytes
E1280 -
97(2008)
Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell
Mutagenicity
F619 - 03(2008) Standard Practice for Extraction of Medical Plastics
F719 - 81(2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
F720 - 13
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization
Test
Designation Title
F748 - 06(2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 - 13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F750 - 87(2012) Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
F756 - 13 Standard Practice for Assessment of Hemolytic Properties of Materials
F763 - 04(2010) Standard Practice for Short-Term Screening of Implant Materials
F813 - 07(2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 - 11 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 - 04(2010)
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with
Respect to Effect of Materials on Muscle and Bone
F1027 -
86(2012)
Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic
Materials and Devices
F1408 -
97(2013)
Standard Practice for Subcutaneous Screening Test for Implant Materials
F1439 -
03(2013)
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of
Implant Materials
F1877 -
05(2010)
Standard Practice for Characterization of Particles
F1903 - 10 Standard Practice for Testing For Biological Responses to Particles In Vitro
F1904 -
98(2008)
Standard Practice for Testing the Biological Responses to Particles in vivo
F1983 -
99(2008)
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials
for Implant Applications
F1984 -
99(2013)
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
F2065 -
00(2010)
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by
Solid Materials
F2147 -
01(2010)
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact
Allergens
F2148 - 13
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local
Lymph Node Assay (LLNA)
F2382 -
04(2010)
Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial
Thromboplastin Time (PTT)
F2567 -
06(2010)
Standard Practice for Testing for Classical Pathway Complement Activation in Serum by
Solid Materials
F2808 - 10
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
F2888 - 13
Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for
Hemocompatibility Assessment of Cardiovascular Materials
F2901 - 13 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
Biomaterials and Biomolecules for TEMPs
Designation Title
F2027 - 08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-
Designation Title
Engineered Medical Products
F2064 -
00(2006)e1
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended
for Use in Biomedical and Tissue-Engineered Medical Products Application
F2103 - 11
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials
Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
F2131 - 02(2012)
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
F2150 - 13
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-
Engineered Medical Products
F2212 - 11
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical
Implants and Substrates for 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 (
1
H NMR) Spectroscopy
F2260 -
03(2012)e1
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton
Nuclear Magnetic Resonance (
1
H NMR) Spectroscopy
F2347 - 11
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials
Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
F2450 - 10
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue
Engineered Medical Products
F2602 - 13
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)
F2603 - 06(2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
F2605 - 08e1
Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size
Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
F2791 - 09
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two
Dimensions
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
F2900 - 11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine
Cardiovascular Standards
Designation Title
F1830 - 97(2013) Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps
F1841 - 97(2013) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
F2079 - 09(2013) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
F2081 - 06(2013)
Standard Guide for Characterization and Presentation of the Dimensional Attributes of
Vascular Stents
F2394 - 07(2013)
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted
on Delivery System
F2477 - 07(2013) Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
F2514 - 08
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to
Uniform Radial Loading
F2606 - 08
Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent
Systems
Designation Title
F2743 - 11
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated
Drug-Eluting Vascular Stent Systems
F2914 - 12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
F2942 - 13
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular
Stents
F3036 - 13 Standard Guide for Testing Absorbable Stents
Cells and Tissue Engineered Constructs for TEMPs
Designation Title
F2149 -
01(2007)
Standard Test Method for Automated Analyses of Cells-the Electrical Sensing Zone Method
of Enumerating and Sizing Single Cell Suspensions
F2210 -
02(2010)
Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered
Medical Products
F2315 - 11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
F2664 - 11
Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical
Methods
F2739 - 08 Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds
F2944 - 12
Standard Test Method for Automated Colony Forming Unit (CFU) Assays—Image
Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in
Culture
F2997 - 13
Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor
Cells Using Fluorescent Image Analysis
Ceramic Materials
Designation Title
F603 - 12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F1088 - 04a(2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1185 - 03(2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants
F1538 - 03(2009) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
F1581 - 08(2012) Standard Specification for Composition of Anorganic Bone for Surgical Implants
F1609 - 08(2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
F1926 / F1926M -
10
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate
Granules, Fabricated Forms, and Coatings
F2024 - 10
Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-
Sprayed Hydroxyapatite Coatings
F2224 - 09(2014)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for
Surgical Implants
F2393 - 12
Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-
PSZ) for Surgical Implant Applications
Classification and Terminology for TEMPs
Designation Title
F2211 - 13 Standard Classification for Tissue Engineered Medical Products (TEMPs)
Designation Title
F2311 - 08 Standard Guide for Classification of Therapeutic Skin Substitutes
F2312 - 11 Standard Terminology Relating to Tissue Engineered Medical Products
Computer Assisted Orthopaedic Surgical Systems
Designation Title
F2554 - 10
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical
Systems
Editorial and Terminology
Designation Title
F2809 - 10 Standard Terminology Relating to Medical and Surgical Materials and Devices
GI Applications
Designation Title
F1992 - 99(2007)
Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory
Instruments (EAI) Used with Flexible Endoscopes
F2528 - 06 Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Implantable Hearing Devices (IHDs)
Designation Title
F2504 - 05(2014)
Standard Practice for Describing System Output of Implantable Middle Ear Hearing
Devices
Material Test Methods
Designation Title
F561 - 13
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues
and Fluids
F640 - 12 Standard Test Methods for Determining Radiopacity for Medical Use
F732 - 00(2011)
Standard Test Method for Wear Testing of Polymeric Materials Used in Total J oint
Prostheses
F746 - 04(2009)e1
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant
Materials
F897 - 02(2013)
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and
Screws
F1044 - 05(2011)e1
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic
Coatings
F1089 - 10 Standard Test Method for Corrosion of Surgical Instruments
F1147 - 05(2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1160 - 05(2011)e1
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and
Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
F1536 - 95(2010)
Standard Test Method for Determining Strength and Setting Time of Synthetic Water-
Activated Polyurethane Fiberglass Orthopaedic Casting Tape
F1634 - 95(2008) Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite
Designation Title
Materials and Implant Devices
F1635 - 11
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable
Polymer Resins and Fabricated Forms for Surgical Implants
F1801 - 97(2009)e1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
F1854 - 09
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical
Implants
F1875 - 98(2009)
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip
Femoral Head-bore and Cone Taper Interface
F1978 - 12
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray
Coatings by Using the Taber Abraser
F2003 - 02(2008)
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene
after Gamma Irradiation in Air
F2004 - 05(2010)
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by
Thermal Analysis
F2052 - 06e1
Standard Test Method for Measurement of Magnetically Induced Displacement Force on
Medical Devices in the Magnetic Resonance Environment
F2082 - 06
Standard Test Method for Determination of Transformation Temperature of Nickel-
Titanium Shape Memory Alloys by Bend and Free Recovery
F2102 - 13
Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms
Intended for Surgical Implants
F2118 - 10
Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone
Cement Materials
F2119 - 07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2129 - 08
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization
Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
F2182 - 11a
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near
Passive Implants During Magnetic Resonance Imaging
F2183 - 02(2008)
Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight
Polyethylene Used in Surgical Implants
F2213 - 06(2011)
Standard Test Method for Measurement of Magnetically Induced Torque on Medical
Devices in the Magnetic Resonance Environment
F2214 - 02(2008)
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked
Ultra High Molecular Weight Polyethylene (UHMWPE)
F2255 - 05(2010)
Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by
Tension Loading
F2256 - 05(2010)
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension
Loading
F2258 - 05(2010) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
F2381 - 10
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-
Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by
Infrared Spectroscopy
F2392 - 04(2010) Standard Test Method for Burst Strength of Surgical Sealants
F2458 - 05(2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
F2459 - 12
Standard Test Method for Extracting Residue from Metallic Medical Components and
Quantifying via Gravimetric Analysis
Designation Title
F2503 - 13
Standard Practice for Marking Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment
F2516 - 07e2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
F2537 - 06(2011)
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to
Measure Micromotion
F2625 - 10
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
F2754 / F2754M -
09(2013)
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of
Coiled Wire
F2778 - 09
Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone
(PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared
Spectroscopy (R-FTIR)
F2819 - 10
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to
be used for Medical Devices
F2847 - 10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
F2977 - 13
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in
Surgical Implants
F2995 - 13 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
Medical/Surgical Instruments
Designation Title
E667 - 98(2009)
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical
Thermometers
E825 - 98(2009)
Standard Specification for Phase Change-Type Disposable Fever Thermometer for
Intermittent Determination of Human Temperature
E1061 - 01(2007) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
E1104 - 98(2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
E1112 - 00(2011)
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient
Temperature
E1299 - 96(2010)
Standard Specification for Reusable Phase-Change-Type Fever Thermometer for
Intermittent Determination of Human Temperature
E1965 - 98(2009)
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient
Temperature
F921 - 10(2011) Standard Terminology Relating to Hemostatic Forceps
F1026 -
86(2008)e1
Standard Specification for General Workmanship and Performance Measurements of
Hemostatic Forceps
F1078 - 10(2011) Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
F1079 -
87(2008)e1
Standard Specification for Inserted and Noninserted Surgical Scissors
F1325 -
91(2008)e1
Standard Specification for Stainless Steel Suture Needle Holders-General Workmanship
Requirements and Corresponding Test Methods
F1613 -
95(2008)e1
Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
F1638 - Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
Designation Title
95(2008)e1
F1744 -
96(2008)e1
Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
F1840 - 10e1 Standard Terminology for Surgical Suture Needles
F1874 - 98(2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
F2062 - 00(2011) Standard Specification for Square Drive Interconnections on Surgical Instruments
F2132 -
01(2008)e1
Standard Specification for Puncture Resistance of Materials Used in Containers for
Discarded Medical Needles and Other Sharps
Metallurgical Materials
Designation Title
F67 - 13
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS
R50250, UNS R50400, UNS R50550, UNS R50700)
F75 - 12
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting
Alloy for Surgical Implants (UNS R30075)
F86 - 13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 - 09
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for
Surgical Implant Applications (UNS R30605)
F136 - 13
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F138 - 13a
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel
Bar and Wire for Surgical Implants (UNS S31673)
F139 - 12
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel
Sheet and Strip for Surgical Implants (UNS S31673)
F560 - 13e1
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS
R05200, UNS R05400)
F562 - 13
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for
Surgical Implant Applications (UNS R30035)
F601 - 13 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F620 - 11
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus
Beta Condition
F621 - 12 Standard Specification for Stainless Steel Forgings for Surgical Implants
F629 - 11 Standard Practice for Radiography of Cast Metallic Surgical Implants
F688 - 10
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
F799 - 11
Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical
Implants (UNS R31537, R31538, R31539)
F899 - 12b Standard Specification for Wrought Stainless Steels for Surgical Instruments
F961 - 08
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for
Surgical Implants (UNS R30035)
F1058 - 08
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum
Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
F1091 - 12
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical
Fixation Wire (UNS R30605)
Designation Title
F1108 -
04(2009)
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical
Implants (UNS R56406)
F1295 - 11
Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant
Applications (UNS R56700)
F1314 - 13ae1
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)
F1350 - 08
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel
Surgical Fixation Wire (UNS S31673)
F1377 - 13
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of
Orthopedic Implants (UNS R30075)
F1472 - 08e1
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical
Implant Applications (UNS R56400)
F1537 - 11
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical
Implants (UNS R31537, UNS R31538, and UNS R31539)
F1580 - 12
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for
Coatings of Surgical Implants
F1586 - 13e1
Standard Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-
3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
F1713 -
08(2013)
Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical
Implant Applications (UNS R58130)
F1813 - 13
Standard Specification for Wrought Titanium–12 Molybdenum–6 Zirconium–2 Iron Alloy for
Surgical Implant (UNS R58120)
F2005 -
05(2010)
Standard Terminology for Nickel-Titanium Shape Memory Alloys
F2063 - 12
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical
Devices and Surgical Implants
F2066 - 13e1
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant
Applications (UNS R58150)
F2146 - 13
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless
Tubing for Surgical Implant Applications (UNS R56320)
F2181 - 09 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
F2229 - 12
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-
1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS
S29108)
F2257 - 09
Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-
2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
F2384 - 10
Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant
Applications (UNS R60901)
F2527 - 10
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)
F2581 - 12
Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-
3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS
S29225)
F2633 - 13
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for
Medical Devices and Surgical Implants
Designation Title
F2885 - 11
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium
Components for Surgical Implant Applications
F2886 - 10
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum
Components for Surgical Implant Applications
F2895 - 10 Standard Practice for Digital Radiography of Cast Metallic Implants
F2989 - 13
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for
Surgical Implant Applications
F3046 - 13
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy for Surgical
Implant Applications (UNS R56320)
Neurosurgical Standards
Designation Title
F452 - 76(2008) Standard Specification for Preformed Cranioplasty Plates
F647 - 94(2006)
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for
Neurosurgical Application
F700 - 93(2008) Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
F701 - 81(2008) Standard Practice for Care and Handling of Neurosurgical Implants and Instruments
F982 - 86(2008)
Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for
Carotid Occlusion
F1266 - 89(2008) Standard Performance Specification for Cerebral Stereotactic Instruments
F1719 - 96(2008) Standard Specification for Image-Interactive Stereotactic and Localization Systems
F1831 - 97(2006)
Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization
Devices
Osteosynthesis
Designation Title
F116 - 12 Standard Specification for Medical Screwdriver Bits
F366 - 10 Standard Specification for Fixation Pins and Wires
F382 - 99(2008)e1 Standard Specification and Test Method for Metallic Bone Plates
F384 - 12
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture
Fixation Devices
F543 - 13e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
F564 - 10 Standard Specification and Test Methods for Metallic Bone Staples
F565 - 04(2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F983 - 86(2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
F1264 - 03(2012) Standard Specification and Test Methods for Intramedullary Fixation Devices
F1541 -
02(2011)e1
Standard Specification and Test Methods for External Skeletal Fixation Devices
F1611 - 00(2013) Standard Specification for Intramedullary Reamers
F1839 - 08(2012)
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for
Testing Orthopaedic Devices and Instruments
F2180 - Standard Specification for Metallic Implantable Strands and Cables
Designation Title
02(2011)e1
F2502 - 11
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal
Fixation Implants
Plastic and Reconstructive Surgery
Designation Title
F703 - 07 Standard Specification for Implantable Breast Prostheses
F881 - 94(2006) Standard Specification for Silicone Elastomer Facial Implants
F1441 - 03(2009) Standard Specification for Soft-Tissue Expander Devices
F2051 - 00(2006) Standard Specification for Implantable Saline Filled Breast Prosthesis
Polymeric Materials
Designation Title
F451 - 08 Standard Specification for Acrylic Bone Cement
F602 - 09 Standard Criteria for Implantable Thermoset Epoxy Plastics
F624 - 09
Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for
Biomedical Applications
F639 - 09 Standard Specification for Polyethylene Plastics for Medical Applications
F641 - 09 Standard Specification for Implantable Epoxy Electronic Encapsulants
F648 - 13
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated
Form for Surgical Implants
F665 - 09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
F702 - 10 Standard Specification for Polysulfone Resin for Medical Applications
F754 - 08
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod
Shapes Fabricated from Granular Molding Powders
F755 - 99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
F997 - 10 Standard Specification for Polycarbonate Resin for Medical Applications
F1855 -
00(2011)
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
F1925 - 09
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for
Surgical Implants
F2026 - 12
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant
Applications
F2038 -
00(2011)
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part
I—Formulations and Uncured Materials
F2042 -
00(2011)
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part
II—Crosslinking and Fabrication
F2313 - 10
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical
Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
F2565 - 13
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight
Polyethylene Fabricated Forms for Surgical Implant Applications
F2579 - 10
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for
Surgical Implants
Designation Title
F2695 - 12
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With
Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
F2759 - 11
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE)
Used in Orthopedic and Spinal Devices
F2820 - 12
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant
Applications
F2848 - 10 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
F2902 - 12 Standard Guide for Assessment of Absorbable Polymeric Implants
Spinal Devices
Designation Title
F1582 -
98(2011)
Standard Terminology Relating to Spinal Implants
F1717 - 14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1798 - 13
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection
Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F2077 - 11 Test Methods For Intervertebral Body Fusion Devices
F2193 -
02(2007)
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of
the Spinal Skeletal System
F2267 -
04(2011)
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body
Fusion Device Under Static Axial Compression
F2346 -
05(2011)
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
F2423 - 11 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
F2624 - 12
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single
Level Spinal Constructs
F2694 -
07(2013)
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total
Facet Prostheses
F2706 - 08
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant
Constructs in a Vertebrectomy Model
F2789 - 10 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
F2790 - 10
Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar
Total Facet Prostheses
Urological Materials and Devices
Designation Title
F623 - 99(2013) Standard Performance Specification for Foley Catheter
F1828 - 97(2006) Standard Specification for Ureteral Stents