ISO 16971-1:2024

Ophthalmic instruments — Optical coherence tomographs — Part 1: Optical coherence tomographs for the posterior segment of the human eye

This document 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 document specifies characteristics and minimum requirements for OCT instruments and systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document. NOTE In this document the term OCT refers to ophthalmic applications.

Instruments ophtalmiques — Tomographe à cohérence optique — Partie 1: Tomographe à cohérence optique du segment postérieur de l'oeil humain

ISO 16971:2015 est applicable aux instruments, systèmes et méthodes de tomographie à cohérence optique (OCT) conçus pour l'imagerie et le mesurage du tissu biologique du segment postérieur de l'?il humain. ISO 16971:2015 définit certains termes propres à ce mode opératoire de diagnostic. ISO 16971:2015 spécifie les exigences minimales relatives aux instruments et systèmes d'OCT. Elle décrit les essais et les modes opératoires qui permettront de vérifier si un système ou instrument est conforme à la présente Norme internationale et entre ainsi dans la catégorie des OCT dits de Norme internationale. Elle spécifie les méthodes et les modes opératoires d'essai classiques qui permettront de vérifier si les capacités de certains systèmes ne satisfont pas aux exigences minimales requises pour les OCT. NOTE Il est prévu d'élargir la présente Norme internationale, lors d'une révision ultérieure, en vue d'inclure tous les segments de l'?il humain.

General Information

• Status: Published
• Publication Date: 07-Nov-2024
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
• Drafting Committee: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
• Current Stage: 6060 - International Standard published
• Start Date: 08-Nov-2024
• Due Date: 08-Nov-2024
• Completion Date: 08-Nov-2024

Relations

• Revises: ISO 16971:2015 - Ophthalmic instruments — Optical coherence tomograph for the posterior segment of the human eye
• Effective Date: 06-Jun-2022

Standards Content (Sample)

International
Standard
ISO 16971-1
First edition
Ophthalmic instruments — Optical
2024-11
coherence tomographs —
Part 1:
Optical coherence tomographs
for the posterior segment of the
human eye
Instruments ophtalmiques — Tomographe à cohérence
optique —
Partie 1: Tomographe à cohérence optique du segment postérieur
de l'oeil humain
Reference number
© ISO 2024
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Published in Switzerland
ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 General .2
3.2 Optical properties .3
3.3 Signal characteristics .4
3.4 Optical coherence tomography angiography .5
3.5 Anatomy and physiology .5
3.6 Data processing.5
3.7 Symbols .5
4 Requirements . 5
4.1 General .5
4.2 Construction and function .6
4.2.1 Optical properties and specifications .6
4.2.2 Tolerance requirements .6
4.2.3 Co-alignment of fundus image and OCT hardware.6
4.2.4 Light hazard protection .6
4.3 Analysis and presentation of results .7
4.3.1 Presentation of structural OCT images .7
4.3.2 Retinal thickness measurement .7
4.3.3 Reference database .7
4.4 Data exchange .7
5 Recommended test methods . 8
5.1 General .8
5.2 Measurement setups .8
5.3 Test methods for optical properties .8
5.3.1 Transverse optical resolution .8
5.3.2 Axial optical resolution .9
5.3.3 Axial range .9
5.3.4 Angular field of view .9
5.4 Test methods for signal quality .9
5.4.1 Sensitivity .9
5.4.2 Axial signal roll-off .9
5.5 Co-alignment of fundus image and OCT scan .9
5.5.1 General .9
5.5.2 En-face method .10
5.5.3 Line scan method .10
6 Information to be supplied by the manufacturer .11
6.1 General .11
6.1.1 Warnings and safety-related information .11
6.1.2 Maintenance . 12
6.2 Technical description. 12
6.2.1 Imaging parameters . 12
6.2.2 Acquisition and scan modes . 12
6.2.3 Measurements and data analysis . 12
6.2.4 Data exchange . 13
6.3 Information available on request. 13
7 Marking . .13
Annex A (informative) Example for test devices . 14

iii
Bibliography .15

iv
Foreword
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This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This first edition of ISO 16971-1 cancels and replaces the first edition (ISO 16971:2015), which has been
technically revised.
The main changes are as follows:
— revision of the dated references;
— document restructured;
— definitions added with particular emphasis on performance parameters;
— added example performance parameters;
— clarified requirements for presentation of OCT images;
— clarified minimum requirements for data exchange; DICOM required;
— test methods not mandatory anymore; added additional test methods;
— extended requirements for the information to be supplied by the manufacturer;
— deleted annex on Minimum requirements for a normative database;
— Annex A Example for test device added.
Any feedback or questions on this document should be directed
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