EN ISO 11979-7:2006
(Main)Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
ISO 11979-7:2006 specifies particular requirements for clinical investigations for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-7:2006)
Dieser Teil von ISO 11979 legt besondere Anforderungen an die klinische Prüfung von monofokalen Hinterkammer- und Vorderkammer-Intraokularlinsen, die zur Korrektur der Aphakie dienen, fest.
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO 11979-7:2006)
L'ISO 11979-7:2006 spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intraoculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie.
Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave (ISO 11979-7:2006)
Ta del standarda EN 13503 določa posebne zahteve za protokole kliničnih raziskav za monofokalne intraokularne leče v zadnjem in sprednjem prekatu za korekcijo afakije.
OPOMBA: Katera koli druga vrsta intraokularnih leč, ki ni neposredno zajeta v standardu EN 13503, in katera koli intraokularna leča, v zvezi s katero želi sponzor raziskati trditve, poleg leč iz standarda EN 13503, se lahko klinično ovrednoti s sklicevanjem na standard EN 540.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN 13503-7:2002
2þHVQLYVDGNL LPSODQWDWL ,QWUDRNXODUQHOHþHGHO .OLQLþQHUD]LVNDYH ,62
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-
7:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-
7:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO
11979-7:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-7:2006
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 11979-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2006
ICS 11.040.70 Supersedes EN 13503-7:2001
English Version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations (ISO 11979-7:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques (ISO 11979-7:2006) Klinische Prüfungen (ISO 11979-7:2006)
This European Standard was approved by CEN on 13 April 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.
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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 11979-7:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 11979-7:2006) 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 13503-7:2001.
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 11979-7:2006 has been approved by CEN as EN ISO 11979-7:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 11979-7
Second edition
2006-05-01
Ophthalmic implants — Intraocular
lenses —
Part 7:
Clinical investigations
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques
Reference number
ISO 11979-7:2006(E)
©
ISO 2006
ISO 11979-7:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 11979-7:2006(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Justification for a clinical investigation . 1
5 Ethical considerations. 1
6 General requirements. 2
6.1 General. 2
6.2 Additional requirements . 2
Annex A (informative) Elements of a clinical investigation . 4
Annex B (informative) Evaluation of post-operative adverse event and visual acuity rates. 13
Bibliography . 18
ISO 11979-7:2006(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 11979-7 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 11979-7:2001), 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
INTERNATIONAL STANDARD ISO 11979-7:2006(E)
Ophthalmic implants — Intraocular lenses —
Part 7:
Clinical investigations
1 Scope
This part of ISO 11979 specifies particular requirements for clinical investigations for posterior and anterior
chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
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 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 Justification for a clinical investigation
The requirements given in ISO 14155-1 shall apply.
If a new model is a minor modification of a model for which the safety and performance have been established
through clinical investigation in accordance with this part of ISO 11979, no or limited clinical investigation is
needed. ISO/TR 22979 provides guidance in determining if a modification is minor.
5 Ethical considerations
For clinical investigations of medical devices for human subjects, the requirements in ISO 14155-1 shall apply.
ISO 11979-7:2006(E)
6 General requirements
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 shall apply, with additional requirements given below.
6.2 Additional requirements
6.2.1 Design
A clinical investigation of an IOL model shall be designed in one of two ways:
a) as an uncontrolled study, in which case the results are compared to the adverse events and visual acuity
rates given in Annex B.
b) as a controlled study, with the provision that the statistical power to detect differences in the adverse
event rates and visual acuity is similar to the uncontrolled study. The control lens shall conform with
applicable parts of ISO 11979.
NOTE Annex A provides guidance for the design of a clinical investigation.
6.2.2 Variables
The following variables shall be considered:
⎯ best spectacle corrected visual acuity (BSCVA);
⎯ refraction;
⎯ intraocular pressure;
⎯ corneal status;
⎯ iritis;
⎯ IOL decentration;
⎯ IOL tilt;
⎯ IOL discoloration;
⎯ IOL opacity;
⎯ cystoid macular oedema;
⎯ hypopyon;
⎯ endophthalmitis;
⎯ pupillary block;
⎯ retinal detachment;
⎯ status of anterior and posterior capsule.
Additional variables can be studied in the clinical investigation to support specific claims.
2 © ISO 2006 – All rights reserved
ISO 11979-7:2006(E)
6.2.3 Other considerations
To minimize the risks associated with the clinical investigation of a new IOL, subject enrolment shall occur in
stages. The subject data from each stage shall be evaluated and found acceptable by the sponsor and the
coordinating investigator prior to the continuation of the clinical investigation. Guidance on phased enrolment
is included in Annex A.
Only the first eye of each subject shall be included in the primary statistical analysis.
Any plans for fellow eye implantation shall be described in the clinical investigation plan. Bilateral implantation
shall not be implemented until initial safety and effectiveness data have been collected, evaluated and
confirmed by the sponsor and principal investigators.
The review of data from at least 50 eyes with six months of follow-up is recommended. Previous clinical
experience, i.e. results from well-documented clinical investigations, may be adequate justification to begin
bilateral implantation earlier in the study.
The duration of the clinical investigation shall be one year for all posterior chamber IOLs, and 3 years for all
anterior chamber IOLs.
The clinical investigation plan shall contain descriptions of the surgical technique, the intraoperative use of
ophthalmic viscosurgical devices, and the use of preoperative, intra-operative and post-operative medications.
Any deviation shall be recorded on the case report forms.
The clinical investigation plan shall describe how subject visits and ophthalmic adverse events in between
reporting periods will be handled in the data analyses.
All subjects in a clinical investigation shall be monitored for the duration of the investigation. The clinical
investigation shall be considered completed when all subjects that have been enrolled in the investigation,
including subjects whose IOL was removed or replaced, have reached the final reporting period.
Serious ophthalmic adverse events and all adverse device effects shall be reported using a special case
report form and forw
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