Volume 13.01 Medical and Surgical Materials and Devices; Anesthetic and Respiratory Equipment; Pharmaceutical Application of Process Analytical Technology

Section 13 - Medical Devices and Services

Volume 13.01, January 2005

Medical and Surgical Materials and Devices; Anesthetic and Respiratory Equipment; Pharmaceutical Application of Process Analytical Technology

E1202-87R03 Guide for Development of Micronucleus Assay Standards

E1262-88R03 Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

E1263-97R03 Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes

E1280-97R03 Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity

E1397-91R03 Practice for Rat Hepatocyte DNA Repair Assay

E1398-91R03 Practice for Rat Hepatocyte DNA Repair Assay

E2363-05 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

F0067-00 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700),

F0075-01 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F0086-04 Practice for Surface Preparation and Marking of Metallic Surgical Implants

F0090-01 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F0116-00R04 Specification for Medical Screwdriver Bits

F0136-02A Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

F0138-03 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F0139-03 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

F0366-04 Specification for Fixation Pins and Wires

F0370 Specification for Proximal Femoral Endoprosthesis

F0382-99R03E01 Specification and Test Method for Metallic Bone Plates

F0384-00 Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

F0451-99AE01 Specification for Acrylic Bone Cement

F0452-76R02 Specification for Preformed Cranioplasty Plates

F0543-02 Specification and Test Methods for Metallic Medical Bone Screws

F0560-05 Specification for Unalloyed Tantalum for Surgical Implant Applications(UNS R05200, UNS R05400)

F0561-05 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

F0562-02 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F0563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563)

F0564-02 Specification and Test Methods for Metallic Bone Staples

F0565-04 Practice for Care and Handling of Orthopedic Implants and Instruments

F0601-03 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

F0602-98AR03 Criteria for Implantable Thermoset Epoxy Plastics

F0603-00 Specification for High-Purity Dense Aluminum Oxide for Medical Application

F0619-03 Practice for Extraction of Medical Plastics

F0620-00 Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants

F0621-02 Specification for Stainless Steel Forgings for Surgical Implants

F0622-79R02 Specification for Preformed Cranioplasty Plates That Can Be Altered

F0623-99E01 Performance Specification for Foley Catheter

F0624-98AR03 Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

F0629-02 Practice for Radiography of Cast Metallic Surgical Implants

F0639-98AR03 Specification for Polyethylene Plastics for Medical Applications

F0640-79R00 Test Methods for Radiopacity of Plastics for Medical Use

F0641-98AR03 Specification for Implantable Epoxy Electronic Encapsulants

F0647-94R00 Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

F0648-04 Specification for Ultra-High-Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F0665-98R03 Classification for Vinyl Chloride Plastics Used in Biomedical Application

F0688-00 Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

F0700-93R02 Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

F0701-81R02 Practice for Care and Handling of Neurosurgical Implants and Instruments

F0702-98AR03 Specification for Polysulfone Resin for Medical Applications

F0703-96R02 Specification for Implantable Breast Prostheses

F0719-81R02E01 Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

F0720-81R02E01 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

F0732-00 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

F0745-00 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications

F0746-04 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

F0748-04 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F0749-98R02E02 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

F0750-87R02E01 Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

F0754-00 Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes

F0755-99R05 Specification for Selection of Porous Polyethylene for Use in Surgical Implants

F0756-00 Practice for Assessment of Hemolytic Properties of Materials

F0763-04 Practice for Short-Term Screening of Implant Materials

F0799-02 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F0813-01 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F0881-94R00 Specification for Silicone Elastomer Facial Implants

F0882-84R02 Performance and Safety Specification for Cryosurgical Medical Instruments

F0895-84R01E01 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F0897-02 Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

F0899-02 Specification for Stainless Steels for Surgical Instruments

F0920-93R99 Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans

F0921-85R02 Terminology Relating to Hemostatic Forceps

F0960 Specification for Medical and Surgical Suction and Drainage Systems

F0961-03 Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

F0965-99 Specification for Rigid Laryngoscopes for Tracheal Intubation\MHook-On Fittings for Laryngoscope Handles and Blades with Lamps

F0981-04 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F0982-86R02 Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion

F0983-86R05 Practice for Permanent Marking of Orthopaedic Implant Components

F0997-98AR03 Specification for Polycarbonate Resin for Medical Applications

F1026-86R02 Specification for General Workmanship and Performance Measurements of Hemostatic Forceps

F1027-86R02 Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

F1044-05 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

F1054 Specification for Conical Fittings

F1058-02 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)

F1078-87R02 Terminology for Surgical Scissors\MInserted and Non-Inserted Blades

F1079-87R02 Specification for Inserted and Noninserted Surgical Scissors

F1088-04A Specification for Beta-Tricalcium Phosphate for Surgical Implantation

F1089-02 Test Method for Corrosion of Surgical Instruments

F1091-02 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire [UNS R30605]

F1100 Specification for Ventilators Intended for Use in Critical Care

F1101-90R03E01 Specification for Ventilators Intended for Use During Anesthesia

F1108-04 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

F1147-05 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

F1160-05 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

F1185-03 Specification for Composition of Hydroxylapatite for Surgical Implants

F1195-99 Specification for Rigid Laryngoscopes for Tracheal Intubation\MHook on Fittings for Fiberilluminated Blades and Handles

F1204 Specification for Anesthesia Reservoir Bags

F1205-88R99 Specification for Anesthesia Breathing Tubes

F1208-89R05 Specification for Minimum Performance and Safety Requirements for Anesthesia Breathing Systems

F1218-89R99 Specification for Bronchoscopes (Rigid)

F1223-05 Test Method for Determination of Total Knee Replacement Constraint

F1242 Specification for Cuffed and Uncuffed Tracheal Tubes

F1243 Specification for Tracheal Tube Connectors

F1246-91R99 Specification for Electrically Powered Home Care Ventilators, Part 1\MPositive-Pressure Ventilators and Ventilator Circuits

F1251-89R03 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

F1264-03 Specification and Test Methods for Intramedullary Fixation Devices

F1266-89R02 Performance Specification for Cerebral Stereotactic Instruments

F1295-05 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

F1314-01 Specification for Wrought Nitrogen Strengthened 22 Chromium \N 13 Nickel \N 5 Manganese \N 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

F1325-91R02 Specification for Stainless Steel Suture Needle Holders-General Workmanship Requirements and Corresponding Test Methods

F1341-99 Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications

F1343-02 Specification for Anesthetic Gas Scavenging Systems\MTransfer and Receiving Systems

F1350-02 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

F1357-99R04 Specification for Articulating Total Wrist Implants

F1377-04 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

F1378-04 Specification for Shoulder Prostheses

F1408-97R02E01 Practice for Subcutaneous Screening Test for Implant Materials

F1415 Specification for Pulse Oximeters

F1439-03 Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

F1440-92R02 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion

F1441-03 Specification for Soft-Tissue Expander Devices

F1452-01 Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors

F1456-01 Specification for Minimum Performance and Safety Requirements for Capnometers

F1462 Specification for Oxygen Analyzers

F1463-93R99 Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care

F1464-93R99 Specification for Oxygen Concentrators for Domiciliary Use

F1472-02A Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1497-99A Test Method for Determining Laser Resistance of the Shaft of Tracheal Tubes

F1518-00 Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera

F1536-95R05 Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape

F1537-00 Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants

F1538-03 Specification for Glass and Glass Ceramic Biomaterials for Implantation

F1541-02 Specification and Test Methods for External Skeletal Fixation Devices

F1542-94R00 Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips

F1573-95R00 Specification for Anesthetic Equipment\MOropharyngeal and Nasopharyngeal Airways

F1579-02E01 Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications

F1580-01 Specification for Titanium and Titanium-6 Aluminum-4\tVanadium Alloy Powders for Coatings of Surgical Implants

F1581-99 Specification for Composition of Anorganic Bone for Surgical Implants

F1582-98R03 Terminology Relating to Spinal Implants

F1586-02 Specification for Wrought Nitrogen Strengthened 21 Chromium\M10 Nickel\M3 Manganese\M2.5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

F1590 Specification for Tracheostomy Tube Connectors

F1609-03 Specification for Calcium Phosphate Coatings for Implantable Materials

F1611-00R04 Specification for Intramedullary Reamers

F1612-95R00 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion

F1613-95R02 Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)

F1627 Specification for Tracheostomy Tubes\NPediatric Tracheostomy Tubes

F1628-95R00 Specification for Labeling and Marking of Cuffed and Uncuffed Tracheal Tubes and Related Treatments Intended for Use During Laser Surgery

F1634-95R00 Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices

F1635-04A Test Method for Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

F1638-95R02 Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

F1659-95 Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates

F1666 Specification for Adult Tracheostomy Tubes

F1672-95R00 Specification for Resurfacing Patellar Prosthesis

F1690-96R04 Specification for Humidifiers for Medical Use\MPart 1: General Requirements for Active Humidification Systems

F1713-03 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

F1714-96R02 Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices

F1715-00E01 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices

F1717-04 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

F1719-96R02 Specification for Image-Interactive Stereotactic and Localization Systems

F1744-96R02E01 Guide for Care and Handling of Stainless Steel Surgical Instruments

F1781-03 Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

F1798-97R03 Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

F1800-04 Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements

F1801-97R04 Practice for Corrosion Fatigue Testing of Metallic Implant Materials

F1813-01 Specification for Wrought Titanium \N 12 Molybdenum \N 6 Zirconium \N 2 Iron Alloy for Surgical Implant (UNS R58120)

F1814-97AR03 Guide for Evaluating Modular Hip and Knee Joint Components

F1820-97R03 Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device

F1828-97 Specification for Ureteral Stents

F1829-98R03 Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear

F1830-97R05 Practice for Selection of Blood for Evaluation of Blood Pumps

F1831-97 Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices

F1839-01 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

F1840-98AR04 Terminology for Surgical Suture Needles

F1841-97R05 Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

F1850-00R05 Specification for Particular Requirements for Anesthesia Workstations and Their Components

F1854-01 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

F1855-00R05 Specification for Polyoxymethylene (Acetal) for Medical Applications

F1873-98 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications

F1874-98R04 Test Method for Bend Testing of Needles Used in Surgical Sutures

F1875-98R04 Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

F1876-98R03E01 Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications

F1877-98R03E01 Practice for Characterization of Particles

F1903-98R03 Practice for Testing For Biological Responses to Particles

F1904-98R03 Practice for Testing the Biological Responses to Particles

F1905-98R03 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity

F1906-98R03 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration

F1925-99R05 Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants

F1926-03 Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings

F1978-00E01 Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber|Pt Abraser

F1981-99 Specification for Suction Catheters for Use in the Respiratory Tract

F1983-99R03 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications

F1984-99R03 Practice for Testing for Whole Complement Activation in Serum by Solid Materials

F1992-99 Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

F2002 Terminology Relating to Anesthesia and Respiratory Equipment

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

F2006-03 Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

F2005-00 Terminology for Nickel-Titanium Shape Memory Alloys

F2009-00 Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

F2024-00 Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

F2025-00 Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment

F2026-02 Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

F2027-00E01 Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products

F2028-02 Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

F2033-05 Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials

F2038-00R05 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I\MFormulations and Uncured Materials

F2042-00R05 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II\MCrosslinking and Fabrication

F2051-00 Specification for Implantable Saline Filled Breast Prosthesis

F2052-02 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

F2062-00 Specification for Square Drive Interconnections on Surgical Instruments

F2063-00 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

F2064-00 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue\NEngineered Medical Products Application

F2065-00E01 Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

F2066-01 Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

F2068-03 Specification for Femoral Prostheses\MMetallic Implants

F2077-03 Test Methods For Intervertebral Body Fusion Devices

F2079-02 Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

F2081-01 Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

F2082-03 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

F2083-04 Specification for Total Knee Prosthesis

F2091-01 Specification for Acetabular Prostheses

F2102-01E01 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants

F2103-01 Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

F2118-03 Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

F2119-01 Test Method for Evaluation of MR Image Artifacts from Passive Implants

F2129-04 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

F2131-02 Test Method for Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line

F2132-01 Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

F2146-01 Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

F2147-01 Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

F2148-01 Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

F2149-01 Test Method for Automated Analyses of Cells\Mthe Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions

F2150-02E01 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

F2151-01 Practice for Assessment of White Blood Cell Morphology After Contact with Materials

F2180-02 Specification for Metallic Implantable Strands and Cables

F2181-02A Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

F2182-02A Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

F2183-02 Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants

F2193-02 Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

F2210-02 Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products

F2211-04 Classification for Tissue Engineered Medical Products (TEMPs)

F2212-02 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

F2213-04 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

F2214-02 Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

F2224-03 Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

F2229-02 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)

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

F2256-05 Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

F2257-03 Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)

F2258-05 Test Method for Strength Properties of Tissue Adhesives in Tension

F2259-03 Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

F2260-03 Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

F2267-04 Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

F2311-03 Guide for Classification of Therapeutic Skin Substitutes

F2312-04 Terminology Relating to Tissue Engineered Medical Products

F2313-03 Specification for Virgin Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

F2315-03 Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

F2345-03 Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

F2346-05 Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

F2347-03 Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

F2381-04 Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy

F2382-04E01 Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

F2383-05 Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

F2384-05 Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

F2385-04 Test Method for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs

F2386-04 Guide for Preservation of Tissue Engineered Medical Products (TEMPs)

F2392-04 Test Method for Burst Strength of Surgical Sealants

F2393-04 Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

F2394-04 Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System

F2450-04 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

F2451-05 Guide for Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

F2458-05 Test Method for Wound Closure Strength of Tissue Adhesives and Sealants