EN ISO 11979-9:2006

SLOVENSKI STANDARD
01-december-2006
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO9HþJRULãþQDLQWUDRNXODUQD
VWHNOD,62
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO
11979-9:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 9: Multifokale Intraokularlinsen (ISO
11979-9:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 9: Lentilles intraoculaires
multifocales (ISO 11979-9:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-9:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11979-9
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2006
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal
intraocular lenses (ISO 11979-9:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 9: Ophthalmische Implantate - Intraokularlinsen - Teil 9:
Lentilles intraoculaires multifocales (ISO 11979-9:2006) Multifokale Intraokularlinsen (ISO 11979-9:2006)
This European Standard was approved by CEN on 19 August 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 11979-9:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11979-9:2006) 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 March 2007, and conflicting national
standards shall be withdrawn at the latest by March 2007.

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 11979-9:2006 has been approved by CEN as EN ISO 11979-9:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 11979-9
First edition
2006-09-01
Ophthalmic implants — Intraocular
lenses —
Part 9:
Multifocal intraocular lenses
Implants ophtalmiques — Lentilles intraoculaires —
Partie 9: Lentilles intraoculaires multifocales

Reference number
ISO 11979-9:2006(E)
©
ISO 2006
ISO 11979-9:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved

ISO 11979-9:2006(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Physical requirements. 2
4.1 General. 2
4.2 Tolerances and dimensions . 2
5 Optical requirements. 2
5.1 General. 2
5.2 Dioptric power. 2
5.3 Imaging quality. 2
5.4 Additional optical characterization. 3
6 Clinical investigation. 3
6.1 General. 3
6.2 Additional requirements for the clinical investigation plan . 4
7 Information supplied by the manufacturer .4
Annex A (normative) Optical characterization . 6
Annex B (informative) Clinical investigation . 8
Annex C (informative) Determination of sample sizes for the clinical investigation . 16
Bibliography . 20

ISO 11979-9:2006(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, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11979-9 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular lenses:
⎯ Part 1: Vocabulary
⎯ Part 2: Optical properties and test methods
⎯ Part 3: Mechanical properties and test methods
⎯ Part 4: Labelling and information
⎯ Part 5: Biocompatibility
⎯ Part 6: Shelf-life and transport stability
⎯ Part 7: Clinical investigations
⎯ Part 8: Fundamental requirements
⎯ Part 9: Multifocal intraocular lenses
⎯ Part 10: Phakic intraocular lenses

iv © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 11979-9:2006(E)

Ophthalmic implants — Intraocular lenses —
Part 9:
Multifocal intraocular lenses
1 Scope
This part of ISO 11979 is applicable to any intraocular lens whose optic provides two or more rotationally
symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful
vision at more than one distance (e.g. far and near).
NOTE The term “near vision” as used in this part of ISO 11979 includes useful vision at a distance of claimed benefit;
e.g. near and/or intermediate distances.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
ISO 11979-2, Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11979-3, Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 11979-4, Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 11979-7, Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14971, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11979-1, ISO 14155-1 and
ISO 14155-2 apply.
ISO 11979-9:2006(E)
4 Physical requirements
4.1 General
This clause is applicable to the physical properties of multifocal intraocular lenses (MIOLs) in the assembled
or final form, as intended for implantation in the human eye.
4.2 Tolerances and dimensions
For tolerances and dimensions, the requirements of ISO 11979-3 apply, together with the following additional
requirement that the manufacturer shall establish tolerances with respect to the optical design.
5 Optical requirements
5.1 General
This clause is applicable to the optical properties and performance requirements of MIOLs in their final form,
as intended for implantation in the human eye.
5.2 Dioptric power
For dioptric power, ISO 11979-2 applies to the far power of an MIOL and to any distinct near power(s).
Two alternative methods for the determination of dioptric power, given in ISO 11979-2, can be applied to
MIOLs. For each near image plane, these methods are modified as follows:
a) for the determination of dioptric power from measured back focal length, once the microscope is focused
on the far image plane and the distance from the back vertex of the MIOL to the distant focal point is
determined, focus the microscope on the near image plane and determine the distance from the back
vertex of the MIOL to the near focal point;
b) for the determination of dioptric power from measured magnification, once the microscope is focused on
the far image plane and the linear dimension, h , in the image is determined, focus the microscope on
image
the near image plane and determine the linear dimension, h , in the image.
image
Depending on the MIOL optic design the correction formulas given in ISO 11979-2 could be invalid. In such
cases, the manufacturer shall derive and justify corrections that result in dioptric powers that are consistent
with power labelling of monofocal IOLs.
If the focusing conditions of ISO 11979-2 are not appropriate for the particular design, another focusing
condition shall be developed with justification.
5.3 Imaging quality
The imaging quality shall be evaluated for the far power and any claimed near power(s) or power range. The
imaging quality specifications apply in all meridians.
For designs t
...