EN ISO 11978:2017

SLOVENSKI STANDARD
01-november-2017
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SIST EN ISO 11978:2015
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Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO
11978:2017)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Étiquetage (ISO 11978:2017)
Ta slovenski standard je istoveten z: EN ISO 11978:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11978
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11978:2014
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Labelling (ISO 11978:2017)
Optique ophtalmique - Lentilles de contact et produits
d'entretien des lentilles de contact - Étiquetage (ISO
11978:2017)
This European Standard was approved by CEN on 8 September 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11978:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 11978:2017) 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 March 2018, and conflicting national standards shall
be withdrawn at the latest by March 2018.
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 11978:2014.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11978:2017 has been approved by CEN as EN ISO 11978:2017 without any modification.

INTERNATIONAL ISO
STANDARD 11978
Third edition
2017-08
Ophthalmic optics — Contact lenses
and contact lens care products —
Labelling
Optique ophtalmique — Lentilles de contact et produits d’entretien
des lentilles de contact — Étiquetage
Reference number
ISO 11978:2017(E)
©
ISO 2017
ISO 11978:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 11978:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Labelling requirements . 1
4.1 General . 1
4.2 Contact lenses . 2
4.3 Contact lens care products . 4
Bibliography . 7
ISO 11978:2017(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 on 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 the following
URL: w w w . i s o .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 11978:2014), of which it constitutes a
minor revision.
The following change has been done:
In 4.1, paragraph 3
“All symbols and written information shall be legible under an illumination of 215 lx with visual acuity
of 20/30 (Visus 0,67).”
has been replaced with
“All symbols and written information shall be a minimum of 0,7 mm in height and be legible at a reading
distance of 30 cm under the illumination of 215 lx, except for Trademarks and any manufacturing part
numbers.”
iv © ISO 2017 – All rights reserved

ISO 11978:2017(E)
Introduction
This document attempts to harmonize requirements, whenever possible, for labelling of contact lenses
and contact lens care products with national laws, regulations, or guidelines that might exist in countries
throughout the world. Where national laws and labelling requirements exist in countries for medical
devices, they are often developed by legislative bodies or regulatory authorities independently from
the development process for International Standards. Therefore, labelling requirements established by
an individual country cannot always be readily integrated into International Standards.
The information given in this document provides a suitable framework for developing labelling for
contact lenses and contact lens care products. Conformance to the elements herein is intended to be
sufficient for developing appropriate labelling for countries without existing laws or regulations
for medical device labelling. However, conformance with the elements of this document might not
be sufficient for full compliance with additional labelling requirements mandated by an individual
country. Where national laws or regulations mandate additional labelling requirements or conflict with
elements of this document, the national law or regulation is intended to be followed and is intended to
take precedence over the elements of this voluntary document.
The manufacturer should provide more information to the contact lens professional upon request.
INTERNATIONAL STANDARD ISO 11978:2017(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Labelling
1 Scope
This document specifies the information to be provided by the manufacturer of contact lenses and
contact lens care products to ensure the correct and safe use of these devices and their accessories by
both types of user of contact lenses: the eye care professional and the contact lens wearer.
This document does not specify the format in which such information shall be provided.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15223–1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 18369–1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369–1 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
4 Labelling requirements
4.1 General
Where practicable and possible, the information supplied by the manufacturer shall be provided in the
language of the country in which the device is distributed. Where appropriate, this information should
take the form of symbols. Symbols used shall conform to ISO 15223–1. Where a symbol is not described
in ISO 15223–1, it shall be described in the documentation supplied with the device.
Provided the minimum essential requirements are fulfilled, the manufacturer may use his discretion
as to the format in which the information is provided, e.g. product-specific information either on the
packaging for each unit or on the sales packaging, or in separated leaflets, brochures, booklets, or
generic handling guides. These may be supplied as hard copy, electronic format, video, etc.
All symbols and written information shall be a minimum of 0,7 mm in height and be legible at a reading
distance
...