Standards

ASTM F748 - 06(2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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E2524 Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

F451 Standard Specification for Acrylic Bone Cement

F602 Standard Criteria for Implantable Thermoset Epoxy Plastics

F619 Standard Practice for Extraction of Medical Plastics

F623 Standard Performance Specification for Foley Catheter

F624 Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

F639 Standard Specification for Polyethylene Plastics for Medical Applications

F641 Standard Specification for Implantable Epoxy Electronic Encapsulants

F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F665 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

F702 Standard Specification for Polysulfone Resin for Medical Applications

F703 Standard Specification for Implantable Breast Prostheses

F749 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

F750 Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

F755 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

F756 Standard Practice for Assessment of Hemolytic Properties of Materials

F763 Standard Practice for Short-Term Screening of Implant Materials

F813 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F881 Standard Specification for Silicone Elastomer Facial Implants

F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F997 Standard Specification for Polycarbonate Resin for Medical Applications

F1027 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices

F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants

F1357 Standard Specification for Articulating Total Wrist Implants

F1378 Standard Specification for Shoulder Prostheses

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

F1441 Standard Specification for Soft-Tissue Expander Devices

F1538 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants

F1635 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

F1672 Standard Specification for Resurfacing Patellar Prosthesis

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

F1781 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

F1813 Standard Specification for Wrought Titanium–12 Molybdenum–6 Zirconium–2 Iron Alloy for Surgical Implant (UNS R58120)

F1828 Standard Specification for Ureteral Stents

F1855 Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

F1903 Standard Practice for Testing For Biological Responses to Particles In Vitro

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

F1925 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

F1984 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

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

F2042 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

F2051 Standard Specification for Implantable Saline Filled Breast Prosthesis

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

F2065 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

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

F2068 Standard Specification for Femoral Prostheses—Metallic Implants

F2083 Standard Specification for Knee Replacement Prosthesis

F2091 Standard Specification for Acetabular Prostheses

F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

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

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

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

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

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

F2313 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 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

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

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

F2565 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

F2567 Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials

F2579 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

F2581 Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)

F2665 Standard Specification for Total Ankle Replacement Prosthesis

F2695 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

F2739 Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds

F2759 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

F2808 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

F2847 Standard Practice for Reporting and Assessment of Residues on Single Use Implants

F2848 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns

F2887 Standard Specification for Total Elbow Prostheses

F2900 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine

Referenced ASTM Standards The documents listed below are referenced within the subject standard but are not provided as part of the standard.