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ISO 15004-1:2020

Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments

Jun 4, 2020

General information

90.93     Sep 5, 2025

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

English   French  

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Published

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Scope

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15004-1:2006

NOW

PUBLISHED
ISO 15004-1:2020
90.93 Standard confirmed
Sep 5, 2025

National adoptions

SRPS EN ISO 15004-1 :2021  
ISS

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)

60.60   Standard published

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