EN 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

• Status: Withdrawn
• Publication Date: 14-Oct-2014
• Withdrawal Date: 12-Sep-2017
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 13-Sep-2017
• Ref Project: SIST EN ISO 11978:2015 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014)

Relations

• Replaces: EN ISO 11978:2000 - Ophtalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer (ISO 11978:2000)
• Effective Date: 22-Oct-2014
• Replaced By: EN ISO 11978:2017 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)
• Effective Date: 20-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11978:2015
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
SIST EN ISO 11978:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11978:2015

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SIST EN ISO 11978:2015

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.

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SIST EN ISO 11978:2015
EN ISO 11978:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 11978:2015
EN ISO 11978:2014 (E)
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.

3

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SIST EN ISO 11978:2015

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SIST EN ISO 11978:2015
INTERNATIONAL ISO
STANDARD 11978
Second edition
2014-10-01
Ophthalmic optics — Contact lenses
and contact lens care products —
Labelling
Optique ophtalmi
...