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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 12-115
Standard
ISO  13695:2004
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
Scope/Abstract
This International Standard specifies methods by which the spectral characteristics such as wavelength, bandwidth, spectral distribution and wavelength stability of a laser beam can be measured. This International Standard is applicable to both continuous wave (cw) and pulsed laser beams. The dependence of the spectral characteristics of a laser on its operating conditions may also be important.
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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