SIST EN ISO 11978:2017/A1:2020
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen - Änderung 1 (ISO 11978:2017/Amd 1:2020)
[No scope available]
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Étiquetage - Amendement 1 (ISO 11978:2017/Amd 1:2020)
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Označevanje - Dopolnilo A1 (ISO 11978:2017/Amd 1:2020)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11978:2017/A1:2020
01-december-2020
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč -
Označevanje - Dopolnilo A1 (ISO 11978:2017/Amd 1:2020)
Ophthalmic optics - Contact lenses and contact lens care products - Labelling -
Amendment 1 (ISO 11978:2017/Amd 1:2020)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen -
Änderung 1 (ISO 11978:2017/Amd 1:2020)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Étiquetage - Amendement 1 (ISO 11978:2017/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 11978:2017/A1:2020
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11978:2017/A1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11978:2017/A1:2020
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SIST EN ISO 11978:2017/A1:2020
EN ISO 11978:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 11.040.70
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Labelling - Amendment 1 (ISO
11978:2017/Amd 1:2020)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und
d'entretien des lentilles de contact - Étiquetage - Kontaktlinsenpflegemittel - Herstellerinformationen -
Amendement 1 (ISO 11978:2017/Amd 1:2020) Änderung 1 (ISO 11978:2017/Amd 1:2020)
This amendment A1 modifies the European Standard EN ISO 11978:2017; it was approved by CEN on 12 October 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 11978:2017/A1:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11978:2017/A1:2020
EN ISO 11978:2017/A1:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11978:2017/A1:2020
EN ISO 11978:2017/A1:2020 (E)
European foreword
This document (EN ISO 11978:2017/A1:2020) 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 April 2021, and conflicting national standards shall be
withdrawn at the latest by April 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.
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 11978:2017/Amd 1:2020 has been approved by CEN as EN ISO 11978:2017/A1:2020
without any modification.
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SIST EN ISO 11978:2017/A1:2020
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SIST EN ISO 11978:2017/A1:2020
INTERNATIONAL ISO
STANDARD 11978
Third edition
2017-08
AMENDMENT 1
2020-10
Ophthalmic optics — Contact lenses
and contact lens care products —
Labelling
AMENDMENT 1
Optique ophtalmique — Lentilles de contact et produits d'entretien
des lentilles de contact — Étiquetage
AMENDEMENT 1
Reference number
ISO 11978:2017/Amd.1:2020(E)
©
ISO 2020
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SIST EN ISO 11978:2017/A1:2020
ISO 11978:2017/Amd.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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 11978:2017/A1:2020
ISO 11978:2017/Amd.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
a
...
SLOVENSKI STANDARD
SIST EN ISO 11978:2017/oprA1:2020
01-marec-2020
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč -
Označevanje - Dopolnilo A1 (ISO 11978:2017/DAM 1:2020)
Ophthalmic optics - Contact lenses and contact lens care products - Labelling -
Amendment 1 (ISO 11978:2017/DAM 1:2020)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Étiquetage - Amendement 1 (ISO 11978:2017/DAM 1:2020)
Ta slovenski standard je istoveten z: prEN ISO 11978:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11978:2017/oprA1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11978:2017/oprA1:2020
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SIST EN ISO 11978:2017/oprA1:2020
DRAFT AMENDMENT
ISO 11978:2017/DAM 1
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-01-28 2020-04-21
Ophthalmic optics — Contact lenses and contact lens care
products — Labelling
AMENDMENT 1
Optique ophtalmique — Lentilles de contact et produits d'entretien des lentilles de contact — Étiquetage
AMENDEMENT 1
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 11978:2017/DAM 1:2020(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 2020
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SIST EN ISO 11978:2017/oprA1:2020
ISO 11978:2017/DAM 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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 11978:2017/oprA1:2020
ISO 11978:2017/DAM 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 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 , Ophthalmic optics and instruments.
This document amends the third edition (ISO 11978:2017).
The main changes compared to the previous edition are as follows:
— detailed description of calculation of legibility requirements;
— addition of informative Annex A;
— addition of references to the Bibliography.
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.
© ISO 2020 – All rights reserved iii
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SIST EN ISO 11978:2017/oprA1:2020
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SIST EN ISO 11978:2017/oprA1:2020
ISO 11978:2017/DAM 1:2020(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Labelling
AMENDMENT 1
4.1, third paragraph
Replace the third paragraph with the following:
All written informat
...
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