SIST EN ISO 11980:2025

SLOVENSKI STANDARD
01-september-2025
Nadomešča:
SIST EN ISO 11980:2013
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Zahteve
in navodilo za klinične raziskave (ISO 11980:2025)
Ophthalmic optics - Contact lenses and contact lens care products - Requirements and
guidance for clinical investigations (ISO 11980:2025)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die klinische
Prüfung (ISO 11980:2025)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Directives pour les investigations cliniques (ISO 11980:2025)
Ta slovenski standard je istoveten z: EN ISO 11980:2025
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11980
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2025
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11980:2012
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Requirements and guidance for clinical
investigations (ISO 11980:2025)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und
d'entretien pour lentilles de contact - Exigences et Kontaktlinsenpflegemittel - Leitfaden für die klinische
recommandations pour les investigations cliniques Prüfung (ISO 11980:2025)
(ISO 11980:2025)
This European Standard was approved by CEN on 24 June 2025.

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, 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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11980:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11980:2025) 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 January 2026, and conflicting national standards shall
be withdrawn at the latest by January 2026.
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 11980:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11980:2025 has been approved by CEN as EN ISO 11980:2025 without any modification.

International
Standard
ISO 11980
Fourth edition
Ophthalmic optics — Contact lenses
2025-06
and contact lens care products —
Requirements and guidance for
clinical investigations
Optique ophtalmique — Lentilles de contact et produits
d’entretien pour lentilles de contact — Exigences et
recommandations pour les investigations cliniques
Reference number
ISO 11980:2025(en) © ISO 2025
ISO 11980:2025(en)
© ISO 2025
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 11980:2025(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Clinical investigational requirements . 1
4.1 General .1
4.2 Additional requirements .2
4.2.1 Study design .2
4.2.2 Contact lens and contact lens care product variables .4
4.3 Other considerations .5
Annex A (informative) Elements of a clinical investigation (CI) . 6
Annex B (informative) Grading scales for the evaluation of safety, physiological performance
and effect on ocular tissues . 19
Annex C (informative) The evaluation of visual, refractive and lens performance and subjective
performance .25
Bibliography .29

iii
ISO 11980:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 7, Ophthalmic optics and instruments, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 170, Ophthalmic optics,in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 11980:2012), which has been technically
revised.
The main changes are as follows:
— the title was changed to reflect the requirements;
— the Scope was clarified;
— the inclusion and exclusion criteria (4.2.1.1) were clarified;
— the appropriate controls in 4.2.1.2, 4.2.1.3 and A.2.2 were clarified;
— the clinical assessment variables (4.2.2.2 and 4.2.2.3) were updated and clarified;
— the guidance for minimum completed participants were updated and the material and design details
(Table A.1) were clarified;
— the contact lens group information for contact lens care product testing (A.2.2.2) was updated;
— the statistical considerations (A.2.3) were clarified;
— the details of serious adverse events (A.2.4.2) were clarified;
— examples of significant adverse events (A.2.4.3) were added;
— to clarify suggested reporting of results, Tables A.2 to A.15 were updated;
— a bulbar conjunctival staining grading scale (B.7) was added;

iv
ISO 11980:2025(en)
— to clarify quadrants of interest, Figure B.2 was updated;
— grading scales for anterior chamber cells and flare (B.9) were added;
— the visual performance testing (C.2) was clarified;
— the refractive performance (C.3) was clarified;
— the front surface deposits grading scale (C.6.2) was revised;
— the Bibliography was updated.
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.

v
ISO 11980:2025(en)
Introduction
Currently, contact lenses and contact lens care products are regulated in different ways in different
countries. This document has been developed to encourage global alignment. Widespread adoption of this
document can represent yet another step toward universal recognition. This document can also be used as a
basis to fulfil design elements of ISO 9001 and or ISO 13485 as well as related national laws.

vi
International Standard ISO 11980:2025(en)
Ophthalmic optics — Contact
...