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ISO 16971-1:2024

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

General information

Valid from 08.11.2024
ICS Groups
11.040.70 Ophthalmic equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
08.11.2024
Main
ISO 16971-1:2024
15.04.2015
Main
ISO 16971:2015
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.

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Paper
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Standard monitoring
English (PDF 1 MB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English