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

2

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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.


3

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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
...

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
requirements applicable to all ophthalmic instruments (ISO/DIS 15004-1:2019)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1:
Allgemeine Anforderungen an ophthalmische Instrumente (ISO/DIS 15004-1:2019)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1:
Exigences générales applicables à tous les instruments ophtalmiques (ISO/DIS 15004-
1:2019)
Ta slovenski standard je istoveten z: prEN ISO 15004-1
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 15004-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 15004-1:2019

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oSIST prEN ISO 15004-1:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15004-1
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-06-07 2019-08-30
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
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15004-1:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019

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oSIST prEN ISO 15004-1:2019
ISO/DIS 15004-1:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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 2019 – All rights reserved

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oSIST prEN ISO 15004-1:2019
ISO/DIS 15004-1:2019(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
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
© ISO 2019 – All rights reserved iii

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oSIST prEN ISO 15004-1:2019
ISO/DIS 15004-1:2019(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 and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 172 Optics and photonics,
Subcommittee SC 7, Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 15004-1:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— normative references were updated;
— change of definition 3.4 manufacturer of ;
— particular requirements about environmental conditions were replaced by a reference to IEC 60601-
1:2005+ A.1:2012;
— Annex A list of product related International Standards for ophthalmic instruments was updated;
— the standard was editorially revised.
A list of all parts in the ISO 15004- series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

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oSIST prEN ISO 15004-1:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 15004-1:2019(E)
Ophthalmic instruments — Fundamental requirements
and test methods —
Part 1:
General requirements applicable to all ophthalmic
instruments
1 Scope
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
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.
2 Normative references
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:
Light hazard protection
IEC 60601-1:2005, + A.1:2012, Medical electrical equipment — Part 1: General requirements for basic safety
and essential performance
IEC 60695-2-10, Fire hazard testing — Part 2-10: Glowing/hot-wire based test methods — Glow-wire
apparatus and common test procedure
IEC 60695-2-11, Fire hazard testing — Part 2-11: Glowing/hot-wire based test methods — Glow-wire
flammability test method for end-products
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at http: //www .iso .org/obp
3.1
ophthalmic instrument
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
disability
© ISO 2019 – All rights reserved 1

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oSIST prEN ISO 15004-1:2019
ISO/DIS 15004-1:2019(E)

3.2
non-invasive ophthalmic instrument
opht
...