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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 053 Date of Entry 12/23/2019 
FR Recognition Number 12-327
Standard
ISO  11551 Third eidtion 2019-10
Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
Scope/Abstract
This International Standard specifies procedures and techniques for obtaining comparable values for the absorptance of optical laser components.
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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