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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
07/06/2020 Radiology 12-334 Complete AAMI RT3:2020 Radiation therapy machine characterization
07/06/2020 Radiology 12-325 Complete NEMA Standards Publication XR 25 -2019 Computed Tomography Dose Check
12/23/2019 Dental/
ENT
4-261 Complete ISO 7405 Third edition 2018-10 Corrected version 2018-12 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
12/23/2019 Orthopedic 11-361 Complete ISO 14243-5 First edition 2019-05 Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
12/21/2020 Biocompatibility 2-282 Complete ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
12/23/2019 General Plastic Surgery/
General Hospital
6-426 Complete ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
07/06/2020 Cardiovascular 3-165 Complete ASTM F1841-19 Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
07/06/2020 Cardiovascular 3-155 Complete IEC 60601-2-47 Edition 2.0 2012-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
ANSI AAMI IEC 60601-2-47:2012/(R)2016 Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
07/06/2020 Sterility 14-545 Complete ISO ASTM 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
08/06/2013 Software/
Informatics
13-55 Complete IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
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