SIST EN ISO 11979-8:2009

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

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)

L'ISO 11979-8:2006 spécifie les exigences fondamentales applicables à tous les types de lentilles intraoculaires destinées à l'implantation chirurgicale dans le segment antérieur de l'oeil humain, à l'exception des implants et transplants cornéens.

Očesni vsadki (implantati) - Intraokularne leče - 8. del: Temeljne zahteve (ISO 11979-8:2006)

General Information

• Status: Withdrawn
• Publication Date: 19-Apr-2009
• Withdrawal Date: 15-Apr-2015
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 15-Apr-2015
• Due Date: 08-May-2015
• Completion Date: 16-Apr-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 11979-8:2009 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

Relations

• Amended By: SIST EN ISO 11979-8:2009/A1:2011 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements - Amendment 1 (ISO 11979-8:2006/Amd 1:2011)
• Effective Date: 08-Jun-2022
• Amended By: SIST EN ISO 11979-8:2009/A1:2011 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements - Amendment 1 (ISO 11979-8:2006/Amd 1:2011)
• Effective Date: 01-Jul-2011
• Replaces: SIST EN ISO 11979-8:2006 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
• Effective Date: 01-May-2009
• Replaced By: SIST EN ISO 11979-8:2015 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)
• Effective Date: 01-May-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-8:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 11979-8:2006
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO7HPHOMQH]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 11979-8:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-8:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-8:2009

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SIST EN ISO 11979-8:2009
EUROPEAN STANDARD
EN ISO 11979-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.70 Supersedes EN ISO 11979-8:2006
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 7 March 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 Ref. No. EN ISO 11979-8:2009: E
worldwide for CEN national Members.

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SIST EN ISO 11979-8:2009
EN ISO 11979-8:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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SIST EN ISO 11979-8:2009
EN ISO 11979-8:2009 (E)
Foreword
The text of ISO 11979-8:2006 has been prepared by Technical Committee ISO/TC 172 “Optics and optical
instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
11979-8:2009 by 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 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 11979-8:2006.
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 93/42/EEC, as
amended by Directive 2007/47/EC.
For relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, 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, 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 11979-8:2006 has been approved by CEN as a EN ISO 11979-8:2009 without any
modification.
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SIST EN ISO 11979-8:2009
EN ISO 11979-8:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the
Essential Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
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, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 – Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
4 & 5 I.1, I.3, II.9.1, II.9.2, II.12.7.1 For optical properties ref. to EN ISO 11979-2,
for mechanical properties ref. to EN ISO 11979-3,
for multifocal IOLs ref. to EN ISO 11979-9 and
for phakic IOLs ref. to EN ISO 11979-10.
6 I.1, II.7.1, II.7.3, II.7.5, II.7.6, II.9.2 For biocompatibility and interaction with YAG-laser
ref. to EN ISO 11979-5.
7 I.1, I.4, I.6, I.6a, II.7.6, II.9.2, For clinical investigation reference to
EN ISO 11979-7, -9 and -10, as applicable.
9 I.1, I.2, II.7.2, II.7.5, II.8.1, II.8.4 Sterility requirement.
Protection against ethylene oxide and derivatives
thereof in case the device is sterilized by ethylene
oxide.
Protection against endotoxins.
10 I.3, I.5, II.8.3, II.8.6, II.9.2 For shelf-life and transport reference to
EN ISO 11979-6.
11 & 12 II.13.1, II.13.2, II.13.3, II.13.5, For labelling and information reference to
II.13.6 EN ISO 11979-4.

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

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SIST EN ISO 11979-8:2009


INTERNATIONAL ISO
STANDARD 11979-8
Second edition
2006-07-01


Ophthalmic implants — Intraocular
lenses —
Part 8:
Fundamental requirements
Implants ophtalmiques — Lentilles intraoculaires —
Partie 8: Exigences fondamentales




Reference number
ISO 11979-8:2006(E)
©
ISO 2006

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SIST EN ISO 11979-8:2009
ISO 11979-8:2006(E)
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SIST EN ISO 11979-8:2009
ISO 11979-8:2006(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,
...