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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Keyword: Detection Capability
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01/15/2013 InVitro Diagnostics 7-233 Complete CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
07/09/2014 Software/
Informatics		 13-65 Complete UL ANSI 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
09/21/2016 InVitro Diagnostics 7-265 Partial CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
08/21/2017 InVitro Diagnostics 7-270 Complete CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
07/15/2019 Sterility 14-532 Complete ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
05/26/2025 Software/
Informatics		 13-147 Complete IEEE Std 11073-10406-2023 Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
08/06/2013 Software/
Informatics		 13-56 Complete ISO IEEE 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
 
 
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