| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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12-367
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| Standard | |
ISO 13695 Second edition 2024-11
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
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Scope/Abstract| This document specifies methods by which the spectral characteristics such as wavelength, bandwidth, spectral distribution and wavelength stability of a laser beam can be measured. This document is applicable to both continuous wave (cw) and pulsed laser beams. The dependence of the spectral characteristics of a laser on its operating conditions may also be important. |
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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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Transition Period
| FDA recognition of ISO 13695:2004 [Rec# 12-115] will be superseded by recognition of ISO 13695 Second edition 2024-11 [Rec# 12-367]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-115] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-115] will not be accepted. |
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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. |
