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ISO 16971:2015

Ophthalmic instruments — Optical coherence tomograph for the posterior segment of the human eye

Apr 15, 2015

General information

90.92     May 21, 2021

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

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Scope

ISO 16971:2015 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.
ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.
ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 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.

Life cycle

NOW

PUBLISHED
ISO 16971:2015
90.92 Standard to be revised
May 21, 2021

REVISED BY

IN_DEVELOPMENT
ISO/CD 16971-1

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