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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 12-106
Standard
ISO  17526 First edition 2003-06-15
Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
Scope/Abstract
This International Standard covers terms and definitions as well as test methods and evaluation procedures to characterize, estimate and predict the longterm behaviour of various types of lasers.
This International Standard defines terms for the lifetime of lasers and specifies test procedures and fundamental aspects for the determination of lifetime. It applies for all types of lasers for which lifetime is a critical issue, including diode lasers except those used in telecommunications.
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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