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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2021 Orthopedic 11-378 Complete ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
06/07/2021 Orthopedic 11-377 Complete ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis
12/23/2019 Orthopedic 11-360 Complete ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
07/15/2019 Orthopedic 11-352 Complete ISO 14242-1 Third edition 2014-10-15 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
09/17/2018 Orthopedic 11-341 Complete ASTM F3140-17 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
09/17/2018 Orthopedic 11-335 Complete ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles
09/17/2018 Orthopedic 11-334 Complete ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
09/17/2018 Orthopedic 11-333 Complete ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates
08/21/2017 Orthopedic 11-321 Complete ASTM F2887-17 Standard Specification for Total Elbow Prostheses
12/23/2016 Orthopedic 11-311 Complete ISO 14243-2 Third edition 2016-09-01 Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
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