EN ISO 11978:2014
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014)
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014)
ISO 11978:2014 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 users of contact lenses: the eye care professional and the contact lens wearer.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen (ISO 11978:2014)
Diese Internationale Norm legt fest, welche Informationen der Hersteller von Kontaktlinsen und Kontaktlinsenpflegemitteln zur Verfügung stellen muss, um den richtigen und sicheren Gebrauch dieser Produkte und ihres Zubehörs durch beide Arten von Anwendern von Kontaktlinsen - den Kontaktlinsenanpasser und den Kontaktlinsenträger - sicherzustellen.
Diese Internationale Norm legt nicht fest, in welcher Form diese Informationen zur Verfügung zu stellen sind.
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Étiquetage (ISO 11978:2014)
L'ISO 11978:2014 spécifie les informations devant être fournies par le fabricant de lentilles de contact et de leurs produits d'entretien, afin de garantir une utilisation correcte et en toute sécurité de ces dispositifs et de leurs accessoires par les deux types d'utilisateur de lentilles de contact: l'adaptateur et le porteur de lentilles.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Informacije proizvajalca (ISO 11978:2014)
Ta mednarodni standard določa informacije, ki jih mora predložiti proizvajalec kontaktnih leč in izdelkov za vzdrževanje kontaktnih leč, da se zagotovi pravilna in varna uporaba teh izdelkov in njihovih pripomočkov za obe vrsti uporabnikov kontaktnih leč: za strokovnjaka za očesno optiko ter uporabnika, ki si vstavlja kontaktne leče. Ta mednarodni standard ne določa oblike, v kateri je treba take informacije predložiti.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2015
1DGRPHãþD
SIST EN ISO 11978:2000
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ
,QIRUPDFLMHSURL]YDMDOFD ,62
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO
11978:2014)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen (ISO
11978:2014)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Étiquetage (ISO 11978:2014)
Ta slovenski standard je istoveten z: EN ISO 11978:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11978
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.70 Supersedes EN ISO 11978:2000
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Labelling (ISO 11978:2014)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien des lentilles de contact - Étiquetage (ISO Herstellerinformationen (ISO 11978:2014)
11978:2014)
This European Standard was approved by CEN on 21 June 2014.
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, 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11978:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11978:2014) 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11978:2000.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11978:2014 has been approved by CEN as EN ISO 11978:2014 without any modification.
INTERNATIONAL ISO
STANDARD 11978
Second edition
2014-10-01
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 11978:2014(E)
©
ISO 2014
ISO 11978:2014(E)
© ISO 2014
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
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO 11978:2014(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 . 1
4.3 Contact lens care products . 4
Bibliography . 7
ISO 11978:2014(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 meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the WTO principles
in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments
This second edition cancels and replaces the first edition (ISO 11978:2000), which has been technically
revised.
iv © ISO 2014 – All rights reserved
ISO 11978:2014(E)
Introduction
This International Standard 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 International Standard 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 International
Standard 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 International Standard, the national law or regulation is intended to be
followed and is intended to take precedence over the elements of this voluntary International Standard.
The manufacturer should provide more information to the contact lens professional upon request.
INTERNATIONAL STANDARD ISO 11978:2014(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Labelling
1 Scope
This International Standard 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 users of contact lenses: the eye care professional and the contact lens wearer.
This International Standard does not specify the format in which such information shall be provided.
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 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.
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 legible under an illumination of 215 lx with visual acuity
of 20/30 (Visus 0,67).
4.2 Contact lenses
The labelling shall include at least the following (indicated in Table 1 by an “X”), exceptions as noted.
ISO 11978:2014(E)
Table 1 — Labelling requirements for contact lenses
Label
Instructions
No. Content Comments
Primary Secondary
for use
container packaging
1 Name or trade name and address of
a
X X X
c
manufacturer
...
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