scope:

NEN-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.