Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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12-327
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Standard | |
ISO 11551 Third eidtion 2019-10 Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components |
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Scope/AbstractThis International Standard specifies procedures and techniques for obtaining comparable values for the absorptance of optical laser components. |
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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. |