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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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(click for recognition information)
 
03/14/2011 Radiology 12-226 Complete IEC 61223-2-6 Second Edition 2006-11 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
03/16/2012 Radiology 12-105 Complete NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
12/21/2020 General I (QS/
RM)		 5-131 Complete IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
12/21/2020 General I (QS/
RM)		 5-132 Complete IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020 Tissue Engineering 15-65 Complete ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
09/17/2018 Orthopedic 11-340 Complete ASTM F3018-17 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
09/17/2018 Radiology 12-319 Complete IEC 60601-2-68 Edition 1.0 2014-09 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
12/21/2020 Dental/
ENT		 4-267 Complete ISO 21606 First edition 2007-06 Dentistry - Elastomeric auxiliaries for use in orthodontics
ANSI ADA Standard No. 105-2010 (R2015) Orthodontic Elastomeric Materials
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
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