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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 12-134
Standard
ISO  11146-1 First edition 2005-01-15
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple 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 only applicable for stigmatic and simple astigmatic beams. If the type of the beam is unknown, and for general astigmatic beams, ISO 11146-2 should be applied.
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FDA recognition of ISO 11146-1 First edition 2005-01-15 [Rec# 12-134] will be superseded by recognition of ISO 11146-1 Second edition 2021-07 [Rec# 12-369]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-134] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-134] 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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