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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 059 Date of Entry 12/19/2022 
FR Recognition Number 12-346
Standard
ISO  12005 Third edition 2022-05
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
Scope/Abstract
This document specifies a method, which is a relatively quick and simple method with minimum equipment, for determining the polarization status and, whenever possible, the degree of polarization of the beam from a continuous wave (cw) laser. It can also be applied to repetitively pulsed lasers, if their electric field vector orientation does not change from pulse to pulse.

This document also specifies the method for determining the direction of the electric-field vector oscillation in the case of (completely or partially) linearly polarized laser beams. It is assumed that the laser radiation is quasimonochromatic and sufficiently stable for the purpose of the measurement. This document is applicable to radiation that has uniform polarization over its cross-sectional area.

The knowledge of the polarization status can be very important for some applications of lasers with a high divergence angle, for instance when the beam of such a laser shall be coupled with polarization dependent devices (e.g. polarization maintaining fibres). This document is applicable not only for a narrow and almost collimated laser beam but also for highly divergent beams as well as for beams with large apertures.
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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