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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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01/14/2019 Orthopedic 11-348 Partial ISO 19227 First edition 2018-03 Implants for surgery - Cleanliness of orthopedic implants - General requirements
05/29/2024 Ophthalmic 10-135 Partial ISO 11979-7 Fifth edition 2024-01 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
07/15/2019 Ophthalmic 10-116 Partial ANSI Z80.35-2018 (R2023) American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
12/20/2021 Biocompatibility 2-294 Partial USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
12/21/2020 General Plastic Surgery/
General Hospital		 6-449 Partial ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
05/29/2023 General Plastic Surgery/
General Hospital		 6-496 Partial ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
01/14/2019 Cardiovascular 3-52 Partial ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes
08/06/2013 InVitro Diagnostics 7-234 Partial CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
08/21/2017 Ophthalmic 10-104 Partial ANSI Z80.20-2016 (R2021) American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
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