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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 12-143
Standard
ISO  15367-2 First edition 2005-03-15
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
Scope/Abstract
This part of ISO 15367 specifies methods for measurement and evaluation of the wavefront distribution function in a transverse plane of a laser beam utilizing Hartmann or Shack-Hartmann wavefront sensors. This part of ISO 15367 is applicable to fully coherent, partially coherent and general astigmatic laser beams, both for pulsed and continuous operation.

Furthermore, reliable numerical methods for both zonal and modal reconstruction of the two-dimensional wavefront distribution together with their uncertainty are described. The knowledge of the wavefront distribution enables the determination of several wavefront parameters that are defined in ISO 15367-1.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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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