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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12-248
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Standard | |
ISO 21254-3 First edition 2011-07-15 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities |
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Scope/AbstractThis part of ISO 21254 specifies two methods of verifying the power density (energy density) handling capability of optical surfaces.
The first method provides a rigorous test that fulfils the requirements at a specified confidence level in the knowledge of potential defects.
The second method provides a simple, and hence inexpensive, test for an empirically derived test level. |
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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. |