New Health Care & Medical Devices Standards

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D7225-13(2019)e1: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors

F1819-19: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique

E2895-19: Standard Practice for Producing High Titers of Viable and Semi-Purified Spores of Clostridium difficile using a Liquid Medium

F2901-19: Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

F623-19: Standard Performance Specification for Foley Catheter

F1378-18: Standard Specification for Shoulder Prostheses

F2313-18: Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

D7103-18: Standard Guide for Assessment of Medical Gloves

E3072-19: Standard Terminology for Industrial Biotechnology

E2147-18: Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

E1564-00(2019): Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials

E1565-00(2019): Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures

E1566-00(2019): Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen

E2888-12(2019): Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

E2871-19: Standard Test Method for Determining Disinfectant Efficacy Against Biofilm Grown in the CDC Biofilm Reactor Using the Single Tube Method

F2579-18: Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

F2888-19: Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials

F2042-18: Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

F702-18: Standard Specification for Polysulfone Resin for Medical Applications

F561-19: Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

F2038-18: Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

F688-19: Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

F2148-18: Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

F997-18: Standard Specification for Polycarbonate Resin for Medical Applications

E1093-91(2019): Standard Specification for Glass Prothrombin Pipet, Disposable

E2276-10(2019): Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

F1580-18: Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

F2450-18: Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products

F2315-18: Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

F1088-18: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

F2554-18: Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

F75-18: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment