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• Draft guidance for industry and FDA staff - Heart valves - Investigational device exemption (IDE) and Premarket Approval (PMA) applications
• Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage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