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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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12/18/2023 General Plastic Surgery/
General Hospital		 6-497 Partial ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
12/18/2023 InVitro Diagnostics 7-319 Complete CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
12/18/2023 Materials 8-605 Complete ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
12/18/2023 Materials 8-606 Complete ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
12/18/2023 Materials 8-607 Complete ASTM F2082/F2082M-23 Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
12/18/2023 Materials 8-608 Complete ASTM F2214-23 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
12/18/2023 Materials 8-609 Complete ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
12/18/2023 Materials 8-610 Complete ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
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