| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
12-368
|
| Standard | |
ISO 13696 Second edition 2022-06
Optics and photonics - Test methods for radiation scattered by optical components |
|
Scope/AbstractThis document specifies procedures for the determination of the total scattering by coated and uncoated optical surfaces. Procedures are given for measuring the contributions of the forward scattering or backward scattering to the total scattering of an optical component.
This document applies to coated and uncoated optical components with optical surfaces that have a radius of curvature of more than 10 m. Measurement wavelengths covered by this document range from the ultraviolet above 250 nm to the infrared spectral region below 15 µm. For measurements in the deep ultraviolet between 190 nm to 250 nm, specific methods are considered and are described. Generally, optical scattering is considered as neglectable for wavelengths above 15 µm |
|
| Extent of Recognition
|
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. |
|
Transition Period
| FDA recognition of ISO 13696:2002 [Rec# 12-116] will be superseded by recognition of ISO 13696:2002 [Rec# 12-368]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-116] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-116] will not be accepted. |
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
