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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2016 Orthopedic 11-316 Complete ASTM F1264-16 Standard Specification and Test Methods for Intramedullary Fixation Devices
04/04/2016 Orthopedic 11-303 Complete ASTM F3047M-15 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
04/04/2016 Orthopedic 11-301 Complete ASTM F2091-15 Standard Specification for Acetabular Prostheses
04/04/2016 Orthopedic 11-299 Complete ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants
01/27/2015 Orthopedic 11-281 Complete ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis
07/09/2014 Orthopedic 11-276 Complete ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
08/06/2013 Orthopedic 11-254 Complete ISO 14630 Fourth edition 2012-12-01 Non-active surgical implants -- General requirements
09/17/2018 Orthopedic 11-185 Complete ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
12/20/2021 Ophthalmic 10-130 Complete ANSI Z80.36-2021 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
12/20/2021 Ophthalmic 10-129 Complete ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
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