EN ISO 11980:2012
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
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 11980:2012)
Diese Internationale Norm legt Leitlinien für die klinische Prüfung (CI; en: clinical investigation) der Sicherheit
und Leistungsfähigkeit von Kontaktlinsen und Kontaktlinsenpflegemitteln fest.
ANMERKUNG Diese Internationale Norm versucht, die gültigen Reglementierungen für die Durchführung einer klinischen
Prüfung zu harmonisieren, die zur Erfüllung der Marktzulassungsvoraussetzungen und Kennzeichnungspflichten
von Kontaktlinsen und Kontaktlinsenpflegemitteln weltweit erforderlich sind. Allerdings variieren die nationalen Anforderungen
erheblich. Wo immer die national übliche Praxis oder Reglementierung gesetzlich verankert ist, hat die Rechtsvorschrift
Vorrang vor dieser Internationalen Norm.
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques (ISO 11980:2012)
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 - Navodilo za klinične raziskave (ISO 11980:2012)
Ta mednarodni standard določa navodila za klinične raziskave (CI) v zvezi z varnostjo in lastnostmi kontaktnih leč in izdelkov za vzdrževanje kontaktnih leč.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2013
1DGRPHãþD
SIST EN ISO 11980:2010
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ1DYRGLOR
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Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical
investigations (ISO 11980:2012)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Directives pour les investigations cliniques (ISO 11980:2012)
Ta slovenski standard je istoveten z: EN ISO 11980:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11980
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 11.040.70 Supersedes EN ISO 11980:2009
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Guidance for clinical investigations (ISO 11980:2012)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien pour lentilles de contact - Directives pour les Leitfaden für die klinische Prüfung (ISO 11980:2012)
investigations cliniques (ISO 11980:2012)
This European Standard was approved by CEN on 14 November 2012.
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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11980:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11980:2012) 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 May 2013, and conflicting national standards shall be withdrawn at the
latest by May 2013.
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 11980:2009.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 11980:2012 has been approved by CEN as a EN ISO 11980:2012 without any modification.
INTERNATIONAL ISO
STANDARD 11980
Third edition
2012-11-15
Ophthalmic optics — Contact lenses and
contact lens care products — Guidance
for clinical investigations
Optique ophtalmique — Lentilles de contact et produits d’entretien pour
lentilles de contact — Directives pour les investigations cliniques
Reference number
ISO 11980:2012(E)
©
ISO 2012
ISO 11980:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 11980:2012(E)
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 . 1
4.3 Other considerations . 4
Annex A (informative) Elements of a clinical investigation . 5
Annex B (informative) Procedures for the evaluation of safety, physiological performance and effect on
ocular tissues .18
Annex C (informative) The evaluation of visual, refractive and lens performance and
subject acceptance .23
Bibliography .26
ISO 11980:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11980 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 11980:2009), which has undergone minor
revision in order to update the normative reference to ISO 14155 and to revise 4.2.1.1 b) 6) and the fifth row of
Table A.1 (overnight wear).
This corrected version of ISO 11980:2012 incorporates the following correction:
— in Table A.12, the final equation corresponding to the total number of eyes has been inserted.
iv © ISO 2012 – All rights reserved
ISO 11980:2012(E)
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 harmonization. Widespread adoption
of this International Standard should represent yet another step toward mutual recognition. This International
[1]
Standard can also be used as a basis to fulfil design elements of ISO 9001 .
INTERNATIONAL STANDARD ISO 11980:2012(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Guidance for clinical investigations
1 Scope
This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of
contact lenses and contact lens care products.
NOTE This International Standard attempts to harmonize the recognized 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 International Standard.
2 Normative references
The following referenced documents are indispensable for the application 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.
4 Clinical investigational requirements
4.1 General
The general requirements for a CI and for a clinical investigation plan (CIP) given in ISO 14155 shall apply, with
additional requirements given below.
4.2 Additional requirements
4.2.1 Study design
4.2.1.1 General
a) The inclusion criteria for subject selection shall relate to the study objectives and should include:
1) subjects with normal eyes who are not using any ocular medications, aged 18 years or over [except
when contact lens investigations have a special indication for use in “children” (for the purposes of
this International Standard, persons less than 18 years of age) such as orthokeratology and paediatric
aphakic lenses];
2) lens powers within the range available for the test lenses;
3) the manifest cylinder less than or equal to 0,75 D (for a study with only spherical power correcting lenses);
ISO 11980:2012(E)
4) 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 subject 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 lenses under investigation
are indicated for irregular cornea, keratoconus or refractive surgery);
6) slit lamp findings that are more serious than grade 1;
7) corneal vascularization greater than 1 mm of penetration;
8) a pathologically dry eye;
9) participation of the subject in a contact lens or contact lens care product clinical trial within the
previous 30 days.
c) The CIP shall provide a description of the monitoring procedure to ensure consistent quality of data
collection and recording.
d) The CIP shall include a statistical analysis plan. Sample size shall be justified, calculated by a validated
statistical software package.
4.2.1.2 Contact lenses
4.2.1.2.1 General. A CI of contact lenses, including daily wear and extended wear hydrogel, silicone hydrogel,
a
...
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