ASTM 규격집(핸드북) Section 13-1권
ASTM Volume 13.01: Medical And Surgical Materials And Devices (I): E667–F2477(의료 및 수술 재료 및 장치(I): E667–F2477)
도서 내 규격수 : 204종
발행월 : 9월
세부목록 :
E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
E1104-98(2023) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
E1262-88(2018) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
E1299-96(2023) Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature
E1965-98(2023) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
E825-98(2023) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
F1026-86(2022) Standard Specification for General Workmanship and Performance Measurements of Hemostatic Forceps
F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
F1044-05(2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
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)
F1078-10(2018) Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
F1079-87(2022) Standard Specification for Inserted and Noninserted Surgical Scissors
F1088-23 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
F1089-18 Standard Test Method for Corrosion of Surgical Instruments
F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147-05(2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate 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
F116-12(2021) Standard Specification for Medical Screwdriver Bits
F1185-23 Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint
F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices
F1295-23 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
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)
F1325-91(2023) Standard Specification for Stainless Steel Suture Needle Holders—General Workmanship Requirements and Corresponding Test Methods
F1350-15 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
F1357-23 Standard Specification for Articulating Total Wrist Implants
F136-13(2021)e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F1377-21 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
F1378-18e1 Standard Specification for Shoulder Prostheses
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)
F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials
F1439-03(2018) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
F1441-03(2022) Standard Specification for Soft-Tissue Expander Devices
F1472-23 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
F1538-03(2017) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices
F1580-18 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
F1581-08(2020) Standard Specification for Composition of Anorganic Bone for Surgical Implants
F1582-98(2016) Standard Terminology Relating to Spinal Implants
F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
F1609-08(2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
F1611-20 Standard Specification for Intramedullary Reamers
F1613-95(2023) Standard Specification for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb Type)
F1635-16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F1638-95(2023) Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
F1672-14(2019) Standard Specification for Resurfacing Patellar Prosthesis
F1713-08(2021)e1 Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
F1714-96(2018) Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1744-96(2016) Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
F1800-19e1 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
F1813-21 Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components
F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
F1828-22 Standard Specification for Ureteral Stents
F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
F1830-19 Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
F1831-17 Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
F1840-10(2023) Standard Terminology for Surgical Suture Needles
F1841-19e1 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F1855-00(2019) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
F1875-98(2022) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
F1877-16 Standard Practice for Characterization of Particles
F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
F1925-22 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
F1926/F1926M-14(2021) Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
F1978-22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F1984-99(2018) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys
F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
F2024-10(2021) Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
F2025-06(2018) Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
F2027-16 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
F2033-20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
F2051-00(2022) Standard Specification for Implantable Saline-Filled Breast Prostheses
F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
F2062-00(2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
F2066-23 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants
F2077-22 Standard Test Methods for Intervertebral Body Fusion Devices
F2079-09(2022) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
F2081-06(2022) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
F2082/F2082M-16 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
F2083-21 Standard Specification for Knee Replacement Prosthesis
F2091-15 Standard Specification for Acetabular Prostheses
F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
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
F2118-14(2020) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
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
F2146-22 Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
F2147-01(2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
F2149-16 Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
F2180-17 Standard Specification for Metallic Implantable Strands and Cables
F2181-20 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
F2211-13(2021) Standard Classification for Tissue-Engineered Medical Products (TEMPs)
F2212-20 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
F2214-16 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
F2224-09(2020) Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
F2229-21 Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F2255-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
F2256-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
F2257-22 Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
F2258-05(2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
F2260-18 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
F2267-22 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
F2312-11(2020) Standard Terminology Relating to Tissue Engineered Medical Products
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
F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
F2346-18 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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
F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
F2384-10(2016) Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
F2385-15(2019) Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
F2392-04(2015) Standard Test Method for Burst Strength of Surgical Sealants
F2393-12(2020) Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
F2394-07(2022) Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System
F2423-11(2020) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
F2450-18 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2458-05(2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
F366-17 Standard Specification for Fixation Pins and Wires
F382-17 Standard Specification and Test Method for Metallic Bone Plates
F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
F451-21 Standard Specification for Acrylic Bone Cement
F452-76(2022) Standard Specification for Preformed Cranioplasty Plates
F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws
F560-22 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F562-22 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F564-17 Standard Specification and Test Methods for Metallic Bone Staples
F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F602-09(2015) Standard Criteria for Implantable Thermoset Epoxy Plastics
F603-12(2020) Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
F621-12(2021)e1 Standard Specification for Stainless Steel Forgings for Surgical Implants
F624-09(2015)e1 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications
F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
F639-09(2015) Standard Specification for Polyethylene Plastics for Medical Applications
F640-23 Standard Test Methods for Determining Radiopacity for Medical Use
F641-09(2023) Standard Specification for Implantable Epoxy Electronic Encapsulants
F647-22 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F665-09(2015) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
F67-13(2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
F700-93(2022) Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments
F702-18 Standard Specification for Polysulfone Resin for Medical Applications
F703-18(2022) Standard Specification for Implantable Breast Prostheses
F719-20e1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F732-17 Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F746-04(2021) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749-20 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F754-08(2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F881-94(2022) Standard Specification for Silicone Elastomer Facial Implants
F895-11(2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F897-19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments
F90-23 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F921-10(2018) Standard Terminology Relating to Hemostatic Forceps
F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
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
F983-86(2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components
F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
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