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Medical Device Standards and Implant Standards

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Medical Device Standards
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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 - 11Standard 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 - 09Standard Specification for Articulating Total Wrist Implants   F1378 - 12Standard 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 Joint Implants   F1800 - 12Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total   Knee Joint Replacements   F1814 - 97a(2009)     Standard Guide for Evaluating Modular Hip and Knee Joint Components   F1820 - 13Standard 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 ProsthesesF2025 - 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 - 12Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing   Surfaces Made of Metallic, Ceramic, and Polymeric Materials   F2068 - 09Standard Specification for Femoral Prostheses—Metallic Implants   F2083 - 12Standard 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 HeadsF2385 - 04(2010)     Standard Test Method for Determining Femoral Head Penetration into Acetabular   Components of Total Hip Replacement Using Clinical Radiographs   F2580 - 13Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip   Prosthesis   F2582 - 08Standard Test Method for Impingement of Acetabular Prostheses   F2665 - 09Standard Specification for Total Ankle Replacement Prosthesis   F2722 - 08Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational   Stops   F2723 - 13aStandard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing   Resistance to Dynamic Disassociation   F2724 - 08Standard Test Method for Evaluating Mobile Bearing Knee Dislocation   F2777 - 10Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and   Deformation Under High Flexion   F2887 - 12Standard Specification for Total Elbow Prostheses   F2943 - 13Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants   Used in Joint Arthroplasty   F2996 - 13Standard 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 - 13Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing   Demineralized Bone (DBM)   F2721 - 09Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects   F2884 - 12Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion   F2903 - 11Standard 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 PlasticsF719 - 81(2012)     Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation   F720 - 13Standard 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 - 13Standard 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 - 13Standard 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 DevicesF895 - 11Standard 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 DevicesF1408 - 97(2013)   Standard Practice for Subcutaneous Screening Test for Implant Materials   F1439 - 03(2013)   Standard Guide for Performance of Lifetime Bioassay for the Tumsrcenic Potential of   Implant Materials   F1877 - 05(2010)   Standard Practice for Characterization of ParticlesF1903 - 10Standard 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 MaterialsF2147 - 01(2010)   Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact    Allergens   F2148 - 13Standard 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 MaterialsF2808 - 10Standard 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 SkinF2888 - 13Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for   Hemocompatibility Assessment of Cardiovascular Materials   F2901 - 13Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices   Biomaterials and Biomolecules for TEMPs Designation Title F2027 - 08Standard 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 - 11Standard 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 - 13Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-   Engineered Medical Products   F2212 - 11Standard 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 - 11Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials   Intended for Use in Biomedical and Tissue Engineered Medical Product Applications   F2450 - 10Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue   Engineered Medical Products   F2602 - 13Standard 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 - 08e1Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size   Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)   F2791 - 09Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two DimensionsF2883 - 11Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant    Applications   F2900 - 11Standard 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 StentsF2394 - 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 - 08Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to   Uniform Radial Loading     F2606 - 08Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent   Systems  
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