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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
Recognition
 
Sort by FR Publication Date [0-9]
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Standard Designation
Number and Date
 
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Title of Standard
 
 
09/09/2008 Software/
Informatics
13-13 CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
09/09/2008 Software/
Informatics
13-12 CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
09/09/2008 Software/
Informatics
13-10 CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
09/09/2008 Software/
Informatics
13-9 CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification
01/14/2019 Radiology 12-324 ISO 13694 Third edition 2018-11 Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
01/14/2019 Radiology 12-323 ISO 11990 Third edition 2018-08 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
01/14/2019 Radiology 12-322 NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
01/14/2019 Radiology 12-321 ANSI IESNA RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
09/17/2018 Radiology 12-320 IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
09/17/2018 Radiology 12-319 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
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