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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 12-248
Standard
ISO  21254-3 First edition 2011-07-15
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
Scope/Abstract
This part of ISO 21254 specifies two methods of verifying the power density (energy density) handling capability of optical surfaces.

The first method provides a rigorous test that fulfils the requirements at a specified confidence level in the knowledge of potential defects.

The second method provides a simple, and hence inexpensive, test for an empirically derived test level.
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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