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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 12-113
Standard
ISO 12005 Second edition 2003-04-01
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
Scope/Abstract
This International Standard specifies a method 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 International Standard also specifies the method for determining the direction of the plane of oscillation in the case of linearly polarized (totally or partially) laser beams. It is assumed that the laser radiation is quasi-monochromatic and sufficiently stable for the purpose of the measurement.
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 International Standard also specifies a method for the determination of the state of polarization of highly divergent laser beams, as well as for the measurement of 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.
Transition Period
FDA recognition of ISO 12005 Second edition 2003-04-01 [Rec# 12-113] will be superseded by recognition of ISO 12005 Third edition 2022-05 [Rec# 12-346]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-113] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 12-113] 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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