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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 049 Date of Entry 06/07/2018 
FR Recognition Number 12-314
Standard
ISO  11554 Fourth edition 2017-07
Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
Scope/Abstract
This document specifies test methods for determining the power and energy of continuous wave and pulsed laser beams, as well as their temporal characteristics of pulse shape, pulse duration and pulse repetition rate. Test and evaluation methods are also given for the power stability of cw-lasers, energy stability of pulsed lasers and pulse duration stability.

The test methods given in this document are used for the testing and characterization of lasers.
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.
Relevant FDA Guidance and/or Supportive Publications*
Guide for Preparing Product Reports for Lasers and Product Containing Lasers,
Form FDA 3632 (8/17) - Product Reports on Lasers and Products Containing Lasers Guide

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 Contacts
 Ilko Ilev
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2489
  ilko.ilev@fda.hhs.gov
 Wlodzimierz Strzelecki
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-6939
  WOODY.STRZELECKI@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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