Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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028
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Date of Entry 03/16/2012
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FR Recognition Number
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12-134
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Standard | |
ISO 11146-1 First edition 2005-01-15 Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
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Scope/AbstractThis part of ISO 11146 specifies methods for measuring beam widths (diameter), divergence angles and beam propagation ratios of laser beams. This part of ISO 11146 is only applicable for stigmatic and simple astigmatic beams. If the type of the beam is unknown, and for general astigmatic beams, ISO 11146-2 should be applied. |
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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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FDA Technical Contact
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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. |