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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12-174
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Standard | |
ISO 13697 First edition 2006-05-15 Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components |
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Scope/AbstractThis International Standard specifies measurement procedures for the precise determination of the specular reflectance and regular transmittance of optical laser components. The accuracy of the described test methods exceeds that of measurement procedures outlined in ISO 15368 by several orders of magnitude. |
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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. |