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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 12-117
Standard
ISO  15367-1 First edition 2003-09-15
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
Scope/Abstract
This part of ISO 15367 specifies methods for the measurement of the topography of the wavefront of a laser beam by measurement and interpretation of the spatial distribution of the phase of that wavefront across a plane approximately perpendicular to its direction of propagation. Requirements are given for the measurement and analysis of phase distribution data to provide quantitative wavefront parameters and their uncertainty in a test report.

The methods described in this part of ISO 15367 are applicable to the testing and characterization of a wide range of beam types from both continuous wave and pulsed lasers. Definitions of parameters describing wavefront deformations are given together with methods for the determination of those parameters from phase distribution measurements.
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ilko Ilev
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2489
  ilko.ilev@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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