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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 019 Date of Entry 12/19/2007 
FR Recognition Number 12-171
Standard
ISO  14880-2:2006
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
Scope/Abstract
This part of ISO 14880 specifies methods for testing wavefront aberrations for microlenses within microlens arrays. It is applicable to microlens arrays with very small lenses formed inside or on one or more surfaces of a common substrate.
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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