ISO 16971-2015 pdf free.Ophthalmic instruments – Optical coherence tomograph for the posterior segment of the human eye.
ISO 16971 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.
This International Standard defines certain terms that are specific to this diagnostic procedure.
This International Standard specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with this International Standard and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.
NOTE It is anticipated that this International Standard can, in a future revision, be expanded to include all segments of the human eye.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15004-1. Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
ISO 1500421), Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 60825-1, Safety of laser products — Part 1: Equipment classification and requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15004-1 and the following apply.
3.1 optical coherence tomography OCT optical interferometric measurement technique for obtaining cross-sectional images of a target object, using a partially coherent narrow scanning beam to determine the relative depths of reflective surfaces within the object
3.2 optical coherence tomograph instrument or system that measures, processes, and displays OCT images of target objects
4 Requirements
4.1 General
4.1.1 General requirements
The OCT shall conform to the requirements specified in ISO 15004-I, IEC 60601-1, IEC 60825-1. and the requirements described in 42 to 4d.
4.1.2 Light hazard protection
The OCT shall conform to all requirements specified in ISO 15004-2 with the exception that if the first edition applies, then for ISO 15004-2:2007, Table 2, and Table 4,, a 3,5 mm diameter irradiance averaging aperture rather than a 1 mm diameter aperture should apply.
4.2 Retinal thickness measurement
4.2.1 General
The calculation of the retinal thickness shall be performed assuming refractive indices within the range from n = 1,33 to n = 1,39.191 11i 1111 1121 (131
4.2.2 Presentation of retinal thickness maps
To facilitate the interpretation and comparison of retinal thickness maps taken with different OCT instruments, a standardized grey scale display should he used.
OCT instruments that make this display available to the user shall designate it as standardized display. NOTE OCT instruments complying with this International Standard can additionally provide displays using parameters different from these standardized ones, e.g. colour displays.
The standardized grey scale display, if used, shall comply with the following: The display shall employ a continuous grey scale with values related to the ratio of reflected/incident light at each resolvable depth. A representation (key) of the grey scale shall be displayed on the screen with the OCT image. The minimum values and the maximum values of the grey scale shall be indicated.
OCT images of the retina can also be displayed using false colour scales to represent different reflectance values or to delineate different retinal sublayers. Sublayers can be defined manually or derived with the aid of segmentation algorithms.ISO 16971 pdf download.