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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 12-142
Standard
ISO 11146-2 First edition 2005-02-15
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
Scope/Abstract
This part of ISO 11146 specifies methods for measuring beam widths (diameter), divergence angles and beam propagation ratios of laser beams. This part of ISO 11146 is applicable to general astigmatic beams or unknown types of beams. For stigmatic and simple astigmatic beams, ISO 11146-1 is applicable.

Within this part of ISO 11146, the description of laser beams is accomplished by means of the second order moments of the Wigner distribution rather than physical quantities such as beam widths and divergence angles. However these physical quantities are closely related to the second order moments of the Wigner distribution. In ISO/TR 11146-3, formulae are given to calculate all relevant physical quantities from the measured second order moments.
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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