EN ISO 11979-10:2006
(Main)Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)
ISO 11979-10:2006 is applicable to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye but excludes phakic IOLs (PIOLs) that utilize multifocal or other simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
ISO 11979-10:2006 addresses specific requirements for PIOLs not addressed in the other parts of ISO 11979.
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Phake Intraokularlinsen (ISO 11979-10:2006)
Dieser Teil von ISO 11979 gilt für Intraokularlinsen (IOL), deren primäre Indikation die Modifikation der Brech¬kraft eines phaken Auges ist. Er gilt nicht für phake IOLs (PIOLs), die multifokale oder sonstige Optiken für das Simultan¬sehen zum Ausgleich eines presbyopen Akkomodationsverlustes einsetzen, sowie PIOL zur Korrektion von Astigmatismus.
Dieser Teil von ISO 11979 enthält besondere Anforderungen an PIOL, die in den übrigen Teilen von ISO 11979 nicht ent¬halten sind.
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Lentilles intraoculaires phaques (ISO 11979-10:2006)
L'ISO 11979-10:2006 s'applique à toute lentille intraoculaire (LIO), dont l'indication primaire est la modification de la puissance de réfraction d'un oeil phaque, mais exclut les LIO phaques (LIOP) qui utilisent des optiques multifocales ou à autre vision simultanée pour traiter la perte d'accommodation liée à la presbytie et les LIOP qui corrigent l'astigmatisme.
L'ISO 11979-10:2006 couvre les exigences spécifiques relatives aux LIOP qui ne sont pas abordées dans les autres parties de l'ISO 11979.
Očesni vsadki (implantati) - Intraokularne leče - 10. del: Intraokularne leče »phakic« (ISO 11979-10:2006)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2006
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Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-
10:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 10: Phake Intraokularlinsen (ISO
11979-10:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Lentilles intraoculaires
phaques (ISO 11979-10:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-10:2006
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 11979-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2006
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 10: Phakic
intraocular lenses (ISO 11979-10:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Ophthalmische Implantate - Intraokularlinsen - Teil 10:
Lentilles intraoculaires phaques (ISO 11979-10:2006) Phake Intraokularlinsen (ISO 11979-10:2006)
This European Standard was approved by CEN on 7 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
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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 11979-10:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 11979-10:2006) 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 February 2007, and conflicting national
standards shall be withdrawn at the latest by February 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 11979-10:2006 has been approved by CEN as EN ISO 11979-10:2006 without
any modifications.
INTERNATIONAL ISO
STANDARD 11979-10
First edition
2006-08-15
Ophthalmic implants — Intraocular
lenses —
Part 10:
Phakic intraocular lenses
Implants ophtalmiques — Lentilles intraoculaires —
Partie 10: Lentilles intraoculaires phaques
Reference number
ISO 11979-10:2006(E)
©
ISO 2006
ISO 11979-10:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 11979-10:2006(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Optical requirements. 1
4.1 General. 1
4.2 Dioptric power. 2
4.3 Imaging quality. 2
4.4 Spectral transmittance . 2
5 Mechanical requirements. 2
6 Clinical investigation. 2
6.1 General. 2
6.2 Clinical assessments. 2
6.3 Other considerations. 3
7 Information supplied by the manufacturer .4
Annex A (informative) Clinical investigation . 5
Annex B (informative) Statistical sample size considerations . 15
Bibliography . 18
ISO 11979-10:2006(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 11979-10 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 11979-10:2006(E)
Ophthalmic implants — Intraocular lenses —
Part 10:
Phakic intraocular lenses
1 Scope
This part of ISO 11979 is applicable to any intraocular lens (IOL) whose primary indication is the modification
of the refractive power of a phakic eye, but excludes phakic IOLs (PIOLs) that utilize multifocal or other
simultaneous vision optics to address presbyopic loss of accommodation and PIOLs that correct astigmatism.
This part of ISO 11979 addresses specific requirements for PIOLs not addressed in the other parts of
ISO 11979.
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 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
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.
4 Optical requirements
4.1 General
This clause applies to the optical properties and performance requirements of PIOLs in their final form, as
intended for implantation in the human eye.
ISO 11979-10:2006(E)
4.2 Dioptric power
The requirements of ISO 11979-2 apply.
4.3 Imaging quality
The requirements of ISO 11979-2 apply.
NOTE A modified bench (e.g. additional converging lens, a microscope objective of appropriate numerical aperture,
etc.) can be needed to quantify the image quality of negative power PIOLs.
4.4 Spectral transmittance
The requirements of ISO 11979-2 apply.
5 Mechanical requirements
Where applicable to the PIOL design, the mechanical requirements given in ISO 11979-3 apply. Furthermore,
an analysis of the location of the PIOL surfaces with respect to ocular tissue shall be conducted to establish
the minimal anatomical dimensions acceptable for the design and the range of dioptric powers for which it
applies.
NOTE Guidance for performing this analysis is provided in ISO 11979-3.
6 Clinical investigation
6.1 General
The general requirements for a clinical investigation given in ISO 14155-1 and the clinical investigation plan
requirements in ISO 14155-2 apply. Additional requirements are given in 6.2 and in 6.3.
NOTE Annex A of this part of ISO 11979 contains suggested details concerning a clinical investigation.
6.2 Clinical assessments
The following assessments shall be considered for the clinical investigation plan:
a) visual acuity (VA);
b) refraction;
c) contrast sensitivity;
d) intraocular pressure;
e) corneal status;
f) iritis;
g) IOL decentration;
h) IOL tilt;
i) IOL discoloration;
2 © ISO 2006 – All rights reserved
ISO 11979-10:2006(E)
j) IOL opacity;
k) cystoid macular edema;
l) hypopyon;
m) endophthalmitis;
n) pupillary block;
o) retinal detachment;
p) status of crystalline lens;
q) status of anterior chamber angle;
r) status of iris;
s) pupil size;
t) corneal thickness.
6.3 Other considerations
To minimize the risks associated with the clinical investigation of a new PIOL, subject enrollment shall occur in
stages. The subject data from each stage shall be evaluated and found acceptable by the sponsor and the
principal investigator prior to the continuation of the clinical inv
...
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