SIST EN ISO 11979-3:2006

SLOVENSKI STANDARD
01-julij-2006
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SIST EN 13503-3:2000
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Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test
methods (ISO 11979-3:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 3: Mechanische Eigenschaften und
Prüfverfahren (ISO 11979-3:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Propriétés mécaniques et
méthodes d'essai (ISO 11979-3:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-3:2006
ICS:
11.040.70
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11979-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2006
ICS 11.040.70 Supersedes EN 13503-3:2000
English Version
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical
properties and test methods (ISO 11979-3:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Ophthalmische Implantate - Intraokularlinsen - Teil 3:
Propriétés mécaniques et méthodes d'essai (ISO 11979- Mechanische Eigenschaften und Prüfverfahren (ISO
3:2006) 11979-3:2006)
This European Standard was approved by CEN on 13 April 2006.
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© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-3:2006: E
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Foreword
This document (EN ISO 11979-3:2006) 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 November 2006, and conflicting national
standards shall be withdrawn at the latest by November 2006.

This document supersedes EN 13503-3:2000.

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 11979-3:2006 has been approved by CEN as EN ISO 11979-3:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 11979-3
Second edition
2006-05-01
Ophthalmic implants — Intraocular
lenses —
Part 3:
Mechanical properties and test methods
Implants ophtalmiques — Lentilles intraoculaires —
Partie 3: Propriétés mécaniques et méthodes d'essai

Reference number
ISO 11979-3:2006(E)
©
ISO 2006
ISO 11979-3:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 11979-3:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Requirements . 1
4.1 General. 1
4.2 Tolerances and dimensions . 2
4.3 Clearance analysis. 2
4.4 Compression force . 2
4.5 Axial displacement in compression. 3
4.6 Optic decentration . 3
4.7 Optic tilt . 3
4.8 Angle of contact. 3
4.9 Compression force decay. 3
4.10 Dynamic fatigue durability. 3
4.11 Surgical manipulation . 4
4.12 Surface and bulk homogeneity . 4
5 Recovery of properties following simulated surgical manipulation . 4
Annex A (normative) Measurement of compression force. 5
Annex B (normative) Measurement of axial displacement in compression . 9
Annex C (normative) Measurement of optic decentration. 12
Annex D (normative) Measurement of optic tilt . 15
Annex E (normative) Measurement of angle of contact. 18
Annex F (normative) Testing of compression force decay. 21
Annex G (normative) Testing of dynamic fatigue durability. 22
Annex H (informative) Measurement of loop pull strength. 24
Annex I (informative) Clearance analysis . 26
Annex J (informative) Precision.29
Bibliography . 30

ISO 11979-3:2006(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 11979-3 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 11979-3:1999), which has been technically
revised.
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

ISO 11979-3:2006(E)
Introduction
This part of ISO 11979 contains methods for which requirements are given and methods for which no
requirements are formulated. The former are considered essential for the safety or performance of the
intraocular lens, while the latter provide essential information to the ophthalmic surgeon or are used for other
purposes.
A special purpose is the use of mechanical data to assess the need for clinical investigation of modifications of
[7]
existing models as described in ISO 11979-7 . Because of the complexity of this analysis, detailed
[8]
descriptions and examples have been given in ISO/TR 22979 . Due to the wide variety of intraocular lens
designs already on the market, it has not been possible to devise test methods that are applicable to every
design under all circumstances. It can be anticipated that new materials currently under development will
result in drastically new designs that will require modified or other test methods. As with all standards, it is
then up to the parties using the standard to modify or develop corresponding methods, and give rationale and
validation for them in a spirit that is consistent with this part of ISO 11979.
In cases where different tolerances have been given depending on material or design, they reflect an existing
situation with well-established products.

INTERNATIONAL STANDARD ISO 11979-3:2006(E)

Ophthalmic implants — Intraocular lenses —
Part 3:
Mechanical properties and test methods
1 Scope
This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of
intraocular lenses (IOLs).
It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye,
excluding corneal implants, provided that the test method is appropriate to the particular IOL design.
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
3 Terms
...