Standards

ASTM F619 - 03(2008) Standard Practice for Extraction of Medical Plastics

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E2097 Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products

F451 Standard Specification for Acrylic Bone Cement

F561 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

F602 Standard Criteria for Implantable Thermoset Epoxy Plastics

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

F719 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

F720 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

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

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

F756 Standard Practice for Assessment of Hemolytic Properties of Materials

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

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

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

F2027 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products

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

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

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

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

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

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

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

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

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

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

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