Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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019
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Date of Entry 12/19/2007
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FR Recognition Number
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12-173
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Standard | |
ISO 14880-4:2006 Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
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Scope/AbstractThis part of ISO 14880 specifies methods for testing optical properties, other than wavefront aberrations, of microlenses in microlens arrays. It is applicable to microlens arrays with very small lenses formed on one or more surfaces of a common substrate and to graded index microlenses.
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Extent of Recognition
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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. |
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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. |
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |