SIST EN ISO 11979-8:2006

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)

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

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-2006
• Withdrawal Date: 15-Apr-2009
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 16-Apr-2009
• Due Date: 09-May-2009
• Completion Date: 16-Apr-2009
• 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 11979-8:2006 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

Relations

• Replaced By: SIST EN ISO 11979-8:2009 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
• Effective Date: 01-May-2009
• Replaces: SIST EN 13503-8:2000 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:1999, modified)
• Effective Date: 01-Sep-2006

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-8:2006
01-september-2006
1DGRPHãþD
SIST EN 13503-8:2000
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 11979-8:2006
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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, compliance with
the normative 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
(Medical Device Directive)

Clause(s)/Sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (ERs) of EU Directive
93/42/EEC
4 & 5 I.1
For optical properties ref. to EN ISO
I.3

11979-2, for mechanical properties ref.
II.9.2
to EN ISO 11979-3, for multifocal IOLs
II.12.7.1
ref. to EN ISO 11979-9 and for phakic
IOLs ref. to EN ISO 11979-10.

I.1
6 For biocompatibility and interaction with
II.7.1
YAG-laser ref. to EN ISO 11979-5.
II.7.3
II.7.5
II.7.6
II.9.2

I.1
7 For clinical investigation reference to EN
I.4
ISO 14155-1, -2 and EN ISO 11979-7,
I.6
and to EN ISO 11979-9 &-10, as
II.7.6
applicable.
II.9.2
II.14

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SIST EN ISO 11979-8:2006
EN ISO 11979-8:2006 (E)


Table ZA.1 (continued)

Clause(s)/Sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (ERs) of EU Directive
93/42/EEC
I.1 Sterility requirement. Reference to EN
9
I.2 ISO 14630.
II.7.2
Protection against the contaminant that
II.7.5
is ethylen oxide.
II.8.1
II.8.4
Protection against leakage.

I.3
10 For shelf-life and transport reference to
I.5
EN ISO 11979-6.
II.8.3
II.8.6
II.9.2

II.8.7
11 & 12 For labelling and information reference
II.13.1
to EN ISO 11979-4, and to EN ISO
II.13.2
11979-9 &-10, as applicable.
II.13.3
II.13.5
II.13.6

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 11979-8:2006


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 11979-8:2006
ISO 11979-8:2006(E)
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SIST EN ISO 11979-8:2006
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
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