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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 011 Date of Entry 10/04/2004 
FR Recognition Number 12-116
Standard
ISO  13696:2002
Optics and optical instruments -- Test methods for radiation scattered by optical components
Scope/Abstract
This International Standard specifies procedures for the determination of the total scattering by coated and uncoated optical surfaces. Procedures are given for measuring the contributions of the forward scattering and backward scattering to the total scattering of an optical component.

This International Standard applies to coated and uncoated optical components with optical surfaces that have a radius of curvature of more than 10 m. The wavelength range includes the ultraviolet, the visible and the infrared spectral regions.
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.
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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