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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/05/2010 InVitro Diagnostics 7-205 Complete CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
05/05/2010 InVitro Diagnostics 7-207 Complete CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
10/04/2010 InVitro Diagnostics 7-212 Complete CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
10/04/2010 Radiology 12-213 Complete IEC 62220-1-2 Edition 1.0 2007-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
10/04/2010 Radiology 12-214 Complete IEC 62220-1-3 Edition 1.0 2008-06 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
10/04/2010 Radiology 12-215 Complete IEC 62494-1 Edition 1.0 (2008-08) Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
03/14/2011 Radiology 12-217 Complete IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
03/14/2011 Radiology 12-221 Complete IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
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
08/02/2011 InVitro Diagnostics 7-219 Complete CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
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