• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Standards and Guidance Documents Impacted by the Solid Mechanics Laboratory

Guidance documents:

  • Guidance for Industry and FDA Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
  • Guidance for Industry and FDA staff - External Infusion Pumps - Premarket notification [510(k)] submissions
  • Draft guidance for industry and FDA staff - Heart valves - Investigational device exemption (IDE) and Premarket Approval (PMA) applications
  • Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

Standards:

  • AAMI TIR 30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
  • AAMI N059 Cardiac Rhythm Management (ICD/Pacemaker leads Test Methods)
  • ASTM F04.3006 Endovascular Devices Test Method Group (Fatigue to Fracture Working Group)
  • ASTM F640 Standard Test Methods for Determining Radiopacity for Medical Use
  • ASTM F1635 Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
  • ASTM F1854 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
  • ASTM F1978 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
  • ASTM F2027 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue Engineered Medical Products
  • ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2064 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Applications
  • ASTM F2118 Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
  • ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2129 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
  • ASTM F2150 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineeered Medical Products
  • ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2212 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
  • ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2255 Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
  • ASTM F2256 Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
  • ASTM F2258 Standard Test Method for Strength Properties of Tissue Adhesives in Tension
  • ASTM F2259 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
  • ASTM F2347 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
  • ASTM F2392 Standard Test Method for Burst Strength of Surgical Sealants
  • ASTM F2450 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
  • ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
  • ASTM F2458 Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
  • ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
  • ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
  • ASTM F2516 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
  • ASTM F2603 Standard Guide for interpreting Images of Polymeric Tissue Scaffolds
  • ASTM F2664 Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
  • ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
  • ASTM F2754/F2754M Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
  • ISO 25539-1:2003 Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses
  • ISO/CD 5840-3 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques
  • ISO 9713 Neurosurgical implants -- Self-closing intracranial aneurysm clips
  • ISO/TS 10974 ISO/TC 150/SC 6/JWG2 and IEC SC 62B/JWG1: Requirements for the safety and compatibility of magnetic resonance imaging for patients with an active implantable medical device