EN ISO 11980:2009
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009)
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009)
ISO 11980:2009 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 11980:2009)
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 klini¬schen Prüfung zu harmonisieren, die zur Erfüllung der Marktzulassungsvoraussetzungen und Kennzeichnungs¬pflichten von Kontaktlinsen und Kontaktlinsenpflegemitteln weltweit erforderlich sind. Allerdings variieren die nationalen Anforde¬run¬gen erheblich. Wo immer die national übliche Praxis oder Reglementierung gesetzlich verankert ist, hat die Rechts¬vorschrift Vorrang vor dieser Internationalen Norm.
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques (ISO 11980:2009)
L'ISO 11980:2009 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 11980:2009)
Ta mednarodni standard podaja smernice za klinične raziskave (CI) o varnosti in delovanju kontaktnih leč in izdelkov za vzdrževanje kontaktnih leč.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden für die klinische Prüfung (ISO 11980:2009)Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques (ISO 11980:2009)Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 11980:2009SIST EN ISO 11980:2010en01-januar-2010SIST EN ISO 11980:2010SLOVENSKI
STANDARDSIST EN ISO 11980:20001DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 11980
October 2009 ICS 11.040.70 Supersedes EN ISO 11980:1997English Version
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009) Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Directives pour les investigations cliniques (ISO 11980:2009)
This European Standard was approved by CEN on 10 October 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11980:2009: ESIST EN ISO 11980:2010
Reference numberISO 11980:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO11980Second edition2009-10-15Ophthalmic 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
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ii © ISO 2009 – All rights reserved
ISO 11980:2009(E) © ISO 2009 – All rights reserved iii 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 Variables.4 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.24 Bibliography.28
ISO 11980:2009(E) iv © ISO 2009 – All rights reserved 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 second edition cancels and replaces the first edition (ISO 11980:1997), of which it constitutes a technical revision. It also incorporates the Technical Corrigendum ISO 11980:1997/Cor.1:1998. SIST EN ISO 11980:2010
ISO 11980:2009(E) © ISO 2009 – All rights reserved v 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 Standard can also be used as a basis to fulfil design elements of ISO 9001[1].
INTERNATIONAL STANDARD ISO 11980:2009(E) © ISO 2009 – All rights reserved 1 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 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans 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 14155-1, ISO 14155-2, 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 14155-2 shall apply, with additional requirements given below. SIST EN ISO 11980:2010
ISO 11980:2009(E) 2 © ISO 2009 – All rights reserved 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); 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 equal to or more serious than trace findings (greater than or equal to 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, and rigid gas-permeable contact lenses, shall be designed as one of 4.2.1.2.2 or 4.2.1.2.3. For CIPs to demonstrate safety and performance, as well as special claims (e
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