FprEN ISO 11980
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO/FDIS 11980:2025)
Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO/FDIS 11980:2025)
ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die klinische Prüfung (ISO/FDIS 11980:2025)
Dieses Dokument stellt Anforderungen und Leitlinien für die klinische Prüfung (CI; en: clinical investigation) zum Nachweis der Sicherheit und Leistungsfähigkeit von Kontaktlinsen und Kontaktlinsenpflegemitteln bereit.
ANMERKUNG 1 In diesem Dokument wird versucht, die allgemein anerkannten regulatorischen Anforderungen zur Durchführung einer klinischen Prüfung zu vereinbaren, die zur Erfüllung von Marktzulassungsvoraussetzungen und Kennzeichnungspflichten von Kontaktlinsen und Kontaktlinsenpflegemitteln weltweit erforderlich sind. Allerdings sind die nationalen Anforderungen sehr unterschiedlich. Wo nationale Praxis oder Verordnungen eine rechtliche Anforderung vorschreiben, hat die Rechtsvorschrift Vorrang vor diesem Dokument.
ANMERKUNG 2 Für Indikationen, die über die Korrektion von Refraktionsfehlern hinausgehen, sind zusätzliche Betrachtungen bezüglich Sicherheit und Leistungsfähigkeit in den klinischen Prüfplan (CIP, en: clinical investigation plan) aufzunehmen.
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques (ISO/FDIS 11980:2025)
L'ISO 11980:2012 donne des lignes directrices pour l'investigation clinique concernant la sécurité et les performances des lentilles de contact et des produits d'entretien pour lentilles de contact.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Zahteve in navodilo za klinične raziskave (ISO/FDIS 11980:2025)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 11980:2024
01-september-2024
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Navodilo
za klinične raziskave (ISO/DIS 11980:2024)
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical
investigations (ISO/DIS 11980:2024)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die klinische
Prüfung (ISO/DIS 11980:2024)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Directives pour les investigations cliniques
Ta slovenski standard je istoveten z: prEN ISO 11980
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 11980:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 11980:2024
oSIST prEN ISO 11980:2024
DRAFT
International
Standard
ISO/DIS 11980
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
and contact lens care products —
Voting begins on:
Guidance for clinical investigations
2024-07-01
Optique ophtalmique — Lentilles de contact et produits
Voting terminates on:
d'entretien pour lentilles de contact — Directives pour les
2024-09-23
investigations cliniques
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 11980:2024(en)
oSIST prEN ISO 11980:2024
DRAFT
ISO/DIS 11980:2024(en)
International
Standard
ISO/DIS 11980
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses
Secretariat: DIN
and contact lens care products —
Voting begins on:
Guidance for clinical investigations
Optique ophtalmique — Lentilles de contact et produits
Voting terminates on:
d'entretien pour lentilles de contact — Directives pour les
investigations cliniques
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11980:2024(en)
ii
oSIST prEN ISO 11980:2024
ISO/DIS 11980:2024(en)
Contents Page
Foreword .iv
Introduction .v
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 .26
Bibliography .30
iii
oSIST prEN ISO 11980:2024
ISO/DIS 11980:2024(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 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).
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.
This fourth edition cancels and replaces the third edition (ISO 11980:2012), which has been technically
revised.
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.
iv
oSIST prEN ISO 11980:2024
ISO/DIS 11980:2024(en)
Introduction
Currently, contact lenses and contact lens care products are regulated in different ways in different countries.
This International Standard has been developed to encourage global alignment. Widespread adoption of
this International Standard can represent yet another step toward universal recognition. This International
Standard can also be used as a basis to fulfil design elements of ISO 9001 and/ or (EN) ISO 13485 as well as
related national laws.
v
oSIST prEN ISO 11980:2024
oSIST prEN ISO 11980:2024
DRAFT International Standard ISO/DIS 11980:2024(en)
Ophthalmic optics — Contact lenses and contact lens care
products — Guidance for clinical investigations
1 Scope
This document gives guidelines for the clinical investigation (CI) to establish the safety and performance of
contact lenses and contact lens care products.
NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the
marketing and labelling requirements for contact lenses and contact lens care products around the world. However,
national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this
requirement takes precedence over this document.
NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance
should be included in the clinical investigation plan (CIP).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14534, Ophthalmic optics — Contact lenses and contact lens care products — Fundamental 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 14155, ISO 14534 and
ISO 18369-1 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Clinical investigational requirements
4.1 General
The general requirements for a CI and for a CIP given in ISO 14155 shall apply, with additional requirements
given below.
oSIST prEN ISO 11980:2024
ISO/DIS 11980:2024(en)
4.2 Additional requirements
4.2.1 Study design
4.2.1.1 General
a) The inclusion criteria for participant selection shall relate to the study objectives and should include:
1) participants with eyes appropriate for the study being conducted;
2) participants of appropriate age for the study being conducted (age range to be specified);
3) participants requiring lens powers within the range available for the study lenses;
4) the manifest cylinder less than or equal to 1,00 D (for a study with only spherical power correcting
soft lenses. For rigid contact lenses, the suitable manifest cylinder may be higher and shall be
defined in the inclusion criteria);
5) best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to
LogMAR 0,1).
b) The exclusion criteria for participant selection shall relate to the study objectives and should include,
but not be limited to:
1) anterior segment infection, inflammation or abnormality;
2) any active anterior segment ocular disease that would contraindicate contact lens wear;
3) the use of systemic or ocular medications that would contraindicate contact lens wear;
4) history of herpetic keratitis;
5) history of refractive surgery or irregular cornea (except when the contact lens or contact lens care
product under investigation is indicated for ocular conditions such as irregular cornea, keratoconus
or refractive surgery);
6) slit lamp findings that are more serious than gr
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