EN 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

• Status: Published
• Publication Date: 14-Nov-2012
• Withdrawal Date: 14-May-2013
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Nov-2012
• Completion Date: 15-Nov-2012
• Ref Project: SIST EN ISO 11980:2013 - Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

Relations

• Replaces: EN ISO 11980:2009 - Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009)
• Effective Date: 28-Nov-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11980:2013
01-februar-2013
1DGRPHãþD
SIST EN ISO 11980:2010
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ1DYRGLOR
]DNOLQLþQHUD]LVNDYH,62
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
SIST EN ISO 11980:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11980:2013

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SIST EN ISO 11980:2013


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.

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SIST EN ISO 11980:2013
EN ISO 11980:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11980:2013
EN ISO 11980:2012 (E)
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.
3

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SIST EN ISO 11980:2013

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SIST EN ISO 11980:2013
INTERNATIONAL ISO
STANDARD 11980
Third edition
2012-11-15
Ophthalmic optics — Contact lenses and
contact lens care prod
...