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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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06/07/2021 Cardiovascular 3-166 Partial ISO 81060-2 Third edition 2018-11 [Including AMD1:2020] Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
12/22/2025 Cardiovascular 3-203 Partial IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
01/14/2019 Biocompatibility 2-258 Partial ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ANSI AAMI ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
01/14/2019 Materials 8-179 Partial ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
12/22/2025 General Plastic Surgery/
General Hospital		 6-439 Partial ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
05/25/2026 Biocompatibility 2-313 Partial ISO 10993-1 Sixth edition 2025-11 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
12/18/2023 Dental/
ENT		 4-319 Partial ISO 17730 Second edition 2020-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
05/29/2024 Neurology 17-19 Partial ISO 80601-2-85 Edition 1.0 2021-03 Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
08/21/2017 Software/
Informatics		 13-92 Partial ISO IEEE 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
12/22/2025 Orthopedic 11-433 Partial ASTM F2028-25a Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
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