Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)

ISO 11978:2017 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.
ISO 11978:2017 does not specify the format in which such information shall be provided.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen (ISO 11978:2017)

Dieses Dokument 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.
Dieses Dokument 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 11978:2017)

ISO 11978:2017 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.
ISO 11978:2017 ne spécifie pas la forme sous laquelle doivent être présentées ces informations.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Označevanje (ISO 11978:2017)

Ta dokument določa informacije, ki jih mora predložiti proizvajalec kontaktnih leč in izdelkov za vzdrževanje kontaktnih leč, da se zagotovi pravilna in varna uporaba teh izdelkov ter njihovih pripomočkov za obe vrsti uporabnikov kontaktnih leč: za strokovnjaka za očesno optiko ter uporabnika, ki si vstavlja kontaktne leče.
Ta dokument ne določa oblike, v kateri je treba take informacije predložiti.

General Information

Status
Published
Publication Date
12-Sep-2017
Withdrawal Date
30-Mar-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
13-Sep-2017
Completion Date
13-Sep-2017

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11978:2017
01-november-2017
1DGRPHãþD
SIST EN ISO 11978:2015
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ
2]QDþHYDQMH ,62
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
SIST EN ISO 11978:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11978:2017

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SIST EN ISO 11978:2017


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.

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SIST EN ISO 11978:2017
EN ISO 11978:2017 (E)
Contents Page
European foreword . 3
2

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SIST EN ISO 11978:2017
EN ISO 11978:2017 (E)
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.

3

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SIST EN ISO 11978:2017

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SIST EN ISO 11978:2017
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

---------------------- Page: 7 ----------------------
...

SLOVENSKI STANDARD
oSIST prEN ISO 11978:2017
01-maj-2017
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ
2]QDþHYDQMH ,62)',6
Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO/FDIS
11978:2017)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Étiquetage (ISO/FDIS 11978:2017)
Ta slovenski standard je istoveten z: prEN ISO 11978
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 11978:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11978:2017

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oSIST prEN ISO 11978:2017
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11978
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
and contact lens care products —
Voting begins on:
2017­02-22 Labelling
Voting terminates on:
Optique ophtalmique — Lentilles de contact et produits d’entretien
2017­05-17
des lentilles de contact — Étiquetage
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 11978:2017(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2017

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oSIST prEN ISO 11978:2017
ISO/FDIS 11978:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© 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
CH­1214 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

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oSIST prEN ISO 11978:2017
ISO/FDIS 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 2017 – All rights reserved iii

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oSIST prEN ISO 11978:2017
ISO/FDIS 11978:2017(E)

Foreword
ISO (the International Organization for Standardizatio
...

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