SIST EN ISO 15004-1:2021

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

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.

Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1: Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2020)

Dieses Dokument legt grundlegende Anforderungen für nicht-invasive, aktive und nicht-aktive ophthalmische Instrumente und für Sehhilfen für Sehbehinderte fest. Dieses Dokument ist auch für Tonometer anzuwenden, jedoch nicht für andere ophthalmische Instrumente, die im Kontakt mit dem Augapfel benutzt werden.
Dieses Dokument ist nicht anzuwenden für Operationsmikroskope, Endoskope und Geräte, die zur Untersuchung oder Behandlung des Auges mit Hilfe von Lasern dienen.

Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1: Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-1:2020)

Le présent document spécifie les exigences fondamentales s'appliquant aux instruments ophtalmiques non invasifs, actifs et non actifs, et aux dispositifs pour malvoyants. Il est également applicable aux tonomètres, mais ne s'applique pas aux autres instruments ophtalmiques utilisés au contact du globe oculaire.
Le présent document ne s'applique pas aux microscopes chirurgicaux, aux endoscopes ou aux instruments destinés à l'examen ou au traitement de l'œil par laser.

Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2020)

General Information

• Status: Published
• Public Enquiry End Date: 04-Sep-2019
• Publication Date: 10-Dec-2020
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-Dec-2020
• Due Date: 11-Feb-2021
• Completion Date: 11-Dec-2020
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 15004-1:2020 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)

Relations

• Replaces: SIST EN ISO 15004-1:2009 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
• Effective Date: 01-Jan-2021
• Replaces: SIST EN ISO 15004-1:2009 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15004-1:2021
01-januar-2021
Nadomešča:
SIST EN ISO 15004-1:2009
Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne
zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2020)

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

requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)

Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1:

Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2020)

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

Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-
1:2020)
Ta slovenski standard je istoveten z: EN ISO 15004-1:2020
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15004-1:2021 en

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

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SIST EN ISO 15004-1:2021
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SIST EN ISO 15004-1:2021
EN ISO 15004-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15004-1:2009
English Version
Ophthalmic instruments - Fundamental requirements and
test methods - Part 1: General requirements applicable to
all ophthalmic instruments (ISO 15004-1:2020)

Instruments ophtalmiques - Exigences fondamentales Ophthalmische Instrumente - Grundlegende

et méthodes d'essai - Partie 1: Exigences générales Anforderungen und Prüfverfahren - Teil 1: Allgemeine

applicables à tous les instruments ophtalmiques (ISO Anforderungen an ophthalmische Instrumente (ISO

15004-1:2020) 15004-1:2020)
This European Standard was approved by CEN on 5 September 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-1:2020 E

worldwide for CEN national Members.
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SIST EN ISO 15004-1:2021
EN ISO 15004-1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 15004-1:2021
EN ISO 15004-1:2020 (E)
European foreword

This document (EN ISO 15004-1:2020) has been prepared by Technical Committee ISO/TC 172 "Optics

and photonics" in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the

secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by May 2021, and conflicting national standards shall be

withdrawn at the latest by May 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 15004-1:2009.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 15004-1:2020 has been approved by CEN as EN ISO 15004-1:2020 without any

modification.
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SIST EN ISO 15004-1:2021
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SIST EN ISO 15004-1:2021
INTERNATIONAL ISO
STANDARD 15004-1
Second edition
2020-05
Ophthalmic instruments —
Fundamental requirements and test
methods —
Part 1:
General requirements applicable to all
ophthalmic instruments
Instruments ophtalmiques — Exigences fondamentales et méthodes
d'essai —
Partie 1: Exigences générales applicables à tous les instruments
ophtalmiques
Reference number
ISO 15004-1:2020(E)
ISO 2020
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SIST EN ISO 15004-1:2021
ISO 15004-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 15004-1:2021
ISO 15004-1:2020(E)
Contents Page

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

Bibliography ................................................................................................................................................................................................................................ 7

© ISO 2020 – All rights reserved iii
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SIST EN ISO 15004-1:2021
ISO 15004-1:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

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

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction

...