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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 051 Date of Entry 01/14/2019 
FR Recognition Number 12-324
Standard
ISO  13694 Third edition 2018-11
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
Scope/Abstract
This document specifies methods by which the measurement of power (energy) density distribution is made and defines parameters for the characterization of the spatial properties of laser power (energy)density distribution functions at a given plane.

The methods given in this document are intended to be used for the testing and characterization of both continuous wave (cw) and pulsed laser beams used in optics and optical instruments.

This document provides definitions of terms and symbols to be used in referring to power density distribution, as well as requirements for its measurement. For pulsed lasers, the distribution of time-integrated power density (i.e. energy density) is the quantity most often measured.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§1040.10 Laser products.
§1040.11 Specific purpose laser products.
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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