EN ISO 11979-8:2006
(Main)Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
This Part of EN 13503 provides fundamental requirements of general nature for intraocular lenses. It refers to other standards applicable to intraocular lenses for specific methods and requirements.
Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO 11979-8:2006)
Dieser Teil von ISO 11979 legt grundlegende Anforderungen an Intraokularlinsen fest, die für die Implantation in den vorderen Abschnitt des menschlichen Auges vorgesehen sind, mit Ausnahme von Implantaten und Transplantaten für die Hornhaut.
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Exigences fondamentales (ISO 11979-8:2006)
Očesni vsadki (implantati) - Intraokularne leče - 8. del: Temeljne zahteve (ISO 11979-8:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11979-8:2006
01-september-2006
1DGRPHãþD
SIST EN 13503-8:2000
2þHVQLYVDGNL LPSODQWDWL ,QWUDRNXODUQHOHþHGHO 7HPHOMQH]DKWHYH ,62
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979
-8:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO
11979-8:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Exigences fondamentales
(ISO 11979-8:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-8:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-8:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11979-8:2006
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SIST EN ISO 11979-8:2006
EUROPEAN STANDARD
EN ISO 11979-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.040.70 Supersedes EN 13503-8:2000
English Version
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental
requirements (ISO 11979-8:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Ophthalmische Implantate - Intraokularlinsen - Teil 8:
Exigences fondamentales (ISO 11979-8:2006) Grundlegende Anforderungen (ISO 11979-8:2006)
This European Standard was approved by CEN on 26 June 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-8:2006: E
worldwide for CEN national Members.
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SIST EN ISO 11979-8:2006
EN ISO 11979-8:2006 (E)
Foreword
This document (EN ISO 11979-8:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 January 2007, and conflicting national standards
shall be withdrawn at the latest by January 2007.
This document supersedes EN 13503-8:2000.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, 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.
Endorsement notice
The text of ISO 11979-8:2006 has been approved by CEN as EN ISO 11979-8:2006 without any
modifications.
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SIST EN ISO 11979-8:2006
EN ISO 11979-8:2006 (E)
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC (Medical Device Directive)
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compli
...
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