SIST EN 13503-7:2002

SLOVENSKI STANDARD
01-maj-2002
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Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-
7:2001, modified)
Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-
7:2001, modifiziert)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO
11979-7:2001, modifié)
Ta slovenski standard je istoveten z: EN 13503-7:2001
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 13503-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2001
ICS 11.040.70
English version
Ophthalmic implants - Intraocular lenses - Part 7: Clinical
investigations (ISO 11979-7:2001, modified)
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Ophthalmische Implantate - Intraokularlinsen - Teil 7:
Investigations cliniques (ISO 11979-7:2001, modifié) Klinische Prüfungen (ISO 11979-7:2001, modifiziert)
This European Standard was approved by CEN on 11 November 2001.
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 Management Centre 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, 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
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13503-7:2001 E
worldwide for CEN national Members.

Contents
page
Foreword .3
Introduction .5
1 Scope .5
2 Normative references.5
3 Terms and definitions.6
4 General requirements.6
5 Methodology.7
5.1 General.7
5.2 Requirements before commencement of the clinical investigation.7
5.3 Clinical investigation plan.7
5.4 Role of sponsor .8
5.5 Role of monitor.8
5.6 Role of clinical investigator.8
6 Presentation of results.8
Annex A (normative) Selected definitions .9
Annex B (informative)  Examples of modifications of a parent IOL model.10
Annex C (informative) Elements of an IOL clinical protocol .15
Annex D (informative) Post-operative adverse event and visual acuity rates associated with historical IOL
control populations .23
Bibliography .29
Annex ZA (informative) A-Deviations .28
Bibliography .29
Foreword
This European Standard has been prepared by 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 June 2002, and conflicting national standards shall be withdrawn at the latest by
June 2002.
European Standard EN 13503-7 was developed by CEN/TC 170, Ophthalmic optics, in cooperation with
ISO/TC 172/SC 7, Ophthalmic optics and instruments, and is published in several 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
It always was and still is the intention of the Technical Committees CEN/TC 170 and ISO/TC 172/SC 7 to prepare
identical ISO and CEN Standards on intraocular lenses. However, during the preparation of part 7 of the above
intraocular lenses standards series, problems were encountered with normative references to the existing
ISO 14155 and EN 540 horizontal standards on clinical investigation of medical devices, those being similar but not
identical.
ISO and CEN principles concerning normative references made it impossible to continue the preparation of
identical European and International Standards on the clinical investigation of intraocular lenses. As a result, two
different standards series, ISO 11979 and EN 13503 had to be prepared.
It is the intention of CEN/TC 170 and ISO/TC 172/SC 7 to revise these standards with the goal to end up with
identical ones as soon as identical ISO and CEN horizontal standards become available.
EN 13503 is the modified ISO 11979. The main difference between both series of standards is that ISO 11979 is
based on the reference to ISO 14155 Clinical investigation of medical devices while EN 13503 is based on the
reference to EN 540 Clinical investigation of medical devices for human subjects.
Compared with ISO 11979-7 the present EN 13503-7 does not contain an informative annex detailing modifications
of IOL parent models.
Modifications of ISO 11979 are indicated as follows:

text which has been deleted is striked out;

text which has been changed or added is underlined.
Cross references to ISO 11979-7 are given where possible.
This Part 7 of EN 13503 contains one normative annex A and three informative annexes C, D and ZA.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.
Endorsement notice
The text of the International Standard ISO 11979-7:2001 was approved by CEN as a European Standard with
agreed common modifications as given in the foreword and indicated in the text by strike-out and underlining.
NOTE A-deviations are given in annex ZA (informative).
Introduction
This part of EN 13503 ISO 11979 provides fundamental requirements of a general nature for intraocular lenses. It
refers to other standards applicable to intraocular lenses for specific methods and requirements.
It always was and still is the intention of the Technical Committees ISO/TC 172/SC 7 and CEN/TC 170 to prepare
identical ISO and CEN (European Committee for Standardization) standards on intraocular lenses. However,
during the preparation of this part of EN 13503 ISO 11979, problems were encountered with normative references
to the existing ISO 14155 and EN 540 horizontal standards on clinical investigation of medical devices, which are
similar but not identical.
ISO and CEN principles concerning normative references made it impossible to continue the preparation of
identical International and European Standards on the clinical investigation of intraocular lenses. As a result, two
different standards series have had to be prepared. It is the intention of ISO/TC 172/SC 7 and CEN/TC 170 to
revise these standards with the goal to end up with identical ones as soon as identical ISO and CEN horizontal
standards on clinical investigations become available.
1 Scope
This part of EN 13503 ISO 11979 specifies particular requirements for clinical investigation protocols for posterior
and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
NOTE Any other type of IOL not directly covered by EN 13503 ISO 11979 and any IOL for which the sponsor wishes to
investigate claims in addition to those defined in EN 13503 ISO 11979 may be clinically evaluated by reference to EN 540
ISO 14155.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 11979. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 11979 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
EN 540:1993, Clinical investigation of medical devices for human subjects.ISO 14155:1996, Clinical investigation of
medical devices.
EN ISO 11979-1:1999, Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:1999).
EN 13503-3:2000, Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test methods
(ISO 11979-3:1999, modified). ISO 11979-3, Ophthalmic implants - Intraocular lenses - Part 3: Mechanical
properties and test methods
3 Terms and definitions
For the purposes of this part of EN 13503 ISO 11979, the terms and definitions given in EN 540 ISO 14155 and
EN ISO 11979-1 apply, together with the following.
For the conveniance of users of this part of EN 13503 ISO 11979, some definitions from EN ISO 11979-1 are
reprodcued in annex A. Terms relating to the design of IOLs are given in EN 13503-3 ISO 11979-3.
3.1
serious adverse event
in addition to the definition in EN 540, an event which is potentially sight threatening is also considered a serious
adverse event
NOTE 1    The definition for serious adverse event given in the ICH Harmonized Tripartite Guideline for Good Clinical Practices
also applies (see reference [1] in the bibliography).
NOTE 2 Examples of potentially sight-threatening adverse events are included in Tables D.1 and D.2.
4 General requirements
4  Ethical considerations
For clinical investigations of medical devices for human subjects, the requirements of ISO 14155 apply.
5  Requirements
5.1    General requirements
The requirements given in 5.1 to 5.7 of ISO 14155:1996 shall apply.
5.2    Additional requirements
Clause 4 of EN 540:1993 shall apply, together with the following additional requirements.
4.5    Addition (see 5.2.1 of ISO 11979-7:2001):
Addition:
Clinical investigators shall file adverse event reports of all serious adverse events with the sponsor immediately
after learning of their occurrence. Other adverse events shall be reported on the case report forms.
The sponsor and the sponsor's investigators shall evaluate the rates of adverse events and visual acuity (VA) for
the IOLs under clinical investigation on a continuing basis. If poor results at any investigational site are determined
by clinical judgement to be potentially device related, consideration shall be given to termination of further
en
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