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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 064 Date of Entry 05/26/2025 
FR Recognition Number 12-370
Standard
ISO  11146-2 Second edition 2021-07
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 document specifies methods for measuring beam widths (diameter), divergence angles and beam propagation ratios of laser beams. This document is applicable to general astigmatic beams or unknown types of beams. For stigmatic and simple astigmatic beams, ISO 11146-1 is applicable.

Within this document, 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.
Transition Period
FDA recognition of ISO 11146-2 First edition 2005-02-15 [Rec# 12-142] will be superseded by recognition of ISO 11146-2 Second edition 2021-07 [Rec# 12-370]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-142] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-142] will not be accepted.
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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