EN 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.

General Information

• Status: Withdrawn
• Publication Date: 14-Oct-2009
• Withdrawal Date: 14-Nov-2012
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Nov-2012
• Completion Date: 15-Nov-2012
• Ref Project: SIST EN ISO 11980:2010 - Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009)

Relations

• Replaces: EN ISO 11980:1997 - Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11980:2012 - Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
• Effective Date: 28-Nov-2012

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



SIST EN ISO 11980:2010



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
Management Centre:
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



EN ISO 11980:2009 (E) 2 Contents Page Foreword .3 SIST EN ISO 11980:2010



EN ISO 11980:2009 (E) 3 Foreword This document (EN ISO 11980:2009) 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 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. 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 11980:1997. 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, 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 the United Kingdom. Endorsement notice The text of ISO 11980:2009 has been approved by CEN as a EN ISO 11980:2009 without any modification.
SIST EN ISO 11980:2010



SIST 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
SIST EN ISO 11980:2010



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