New Health Care & Medical Devices Standards

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F2407-20: Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

F619-20: Standard Practice for Extraction of Materials Used in Medical Devices

F2097-20: Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

F2118-14(2020): Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

F2778-09(2020): Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)

F1408-20a: Standard Practice for Subcutaneous Screening Test for Implant Materials

F1581-08(2020): Standard Specification for Composition of Anorganic Bone for Surgical Implants

F2224-09(2020): Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

F2393-12(2020): Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

F2603-06(2020): Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds

F603-12(2020): Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

F3044-20: Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

F1223-20: Standard Test Method for Determination of Total Knee Replacement Constraint

F2996-20: Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

F750-20: Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse

F2181-20: Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

E1936-20: Standard Reference Radiograph for Evaluating the Performance of Radiographic Digitization Systems

F2977-20: Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

E2891-20: Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

F2944-20: Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture

E1327-07(2018): Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

E2614-15(2020)e1: Standard Guide for Evaluation of Cleanroom Disinfectants

F813-20: Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

E1153-14e1: Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

F719-20: Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

E2898-20a: Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

F2009-20: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

E2647-20: Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown Using Drip Flow Biofilm Reactor with Low Shear and Continuous Flow

F1537-20: Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

F1611-20: Standard Specification for Intramedullary Reamers

F2789-10(2020): Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

F2312-11(2020): Standard Terminology Relating to Tissue Engineered Medical Products

F2100-19e1: Standard Specification for Performance of Materials Used in Medical Face Masks

F620-20: Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition