prEN ISO 15004-1

SLOVENSKI STANDARD
oSIST prEN ISO 15004-1:2019
01-september-2019
Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne
zahteve, uporabne za vse oftalmične instrumente (ISO/DIS 15004-1:2019)

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General

Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1:

Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1:

Exigences générales applicables à tous les instruments ophtalmiques (ISO/DIS 15004-

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Fundamental requirements ...................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Design ............................................................................................................................................................................................................. 2

4.3 Performance .............................................................................................................................................................................................. 2

4.4 Combination of different devices ............................................................................................................................................ 2

4.5 Materials ....................................................................................................................................................................................................... 3

4.6 Protection against contaminants ............................................................................................................................................ 3

4.7 Scales and displays .............................................................................................................................................................................. 3

4.8 Thermal hazards .................................................................................................................................................................................... 3

4.9 Mechanical hazards ............................................................................................................................................................................. 3

5 Environmental conditions .......................................................................................................................................................................... 3

6 Particular requirements for active ophthalmic instruments ................................................................................ 3

6.1 Electrical safety ...................................................................................................................................................................................... 3

6.2 Inapplicable clauses of IEC 60601-1 .................................................................................................................................... 3

6.3 Optical radiation hazard ................................................................................................................................................................. 4

7 Test methods ............................................................................................................................................................................................................. 4

7.1 General ........................................................................................................................................................................................................... 4

7.2 Ignitability ................................................................................................................................................................................................... 4

7.3 Surface temperatures ........................................................................................................................................................................ 4

7.4 Electrical safety ...................................................................................................................................................................................... 4

8 Information supplied by the manufacturer ............................................................................................................................. 4

8.1 Accompanying documents ............................................................................................................................................................ 4

8.2 Marking ......................................................................................................................................................................................................... 4

Annex A (informative) Product-related International Standards for ophthalmic instruments .............6

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered .............................................7

Bibliography ................................................................................................................................................................................................................................ 9

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different types of ISO documents should be noted. This document was drafted in accordance with the

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This document was prepared by Technical Committee ISO/TC 172 Optics and photonics,

This third edition cancels and replaces the second edition (ISO 15004-1:2006), which has been

— particular requirements about environmental conditions were replaced by a reference to IEC 60601-

— Annex A list of product related International Standards for ophthalmic instruments was updated;

Any feedback or questions on this document should be directed to the user’s national standards body. A

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic

instruments and to low-vision aids. This document is also applicable to tonometers, but not to other

This document is not applicable to operation microscopes, endoscopes and devices intended for laser

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods — Part 2:

IEC 60601-1:2005, + A.1:2012, Medical electrical equipment — Part 1: General requirements for basic safety

IEC 60695-2-10, Fire hazard testing — Part 2-10: Glowing/hot-wire based test methods — Glow-wire

IEC 60695-2-11, Fire hazard testing — Part 2-11: Glowing/hot-wire based test methods — Glow-wire

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

device designed to have an application to the eye, and intended by its manufacturer to be used in the

diagnosis, treatment, or monitoring of a patient, or for compensation or alleviation of disease, injury or