SIST EN 13503-7:2002

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2001, modified)

This part of EN 13503 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 and any IOL for which the sponsor wishes to investigate claims in addition to those defined in EN 13503 may be clinically evaluated by reference to EN 540.

Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-7:2001, modifiziert)

Dieser Teil von prEN 13503 legt besondere Anforderungen für Protokolle zur klinischen Prüfung von monofokalen Hinterkammer- und Vorderkammer-Intraokularlinsen, die zur Korrektion der Aphakie dienen, fest.
ANMERKUNG   Jegliche andere Typen von Intraokularlinsen, die nicht explizit von prEN 13503 abgedeckt werden, und jegliche Intraokularlinsen, für die der Hersteller Untersuchungen im Hinblick auf von der Norm prEN 13503 nicht behandelte weitere Leistungsmerkmale durchführen möchte, dürfen unter Bezugnahme auf EN 540 klinisch beurteilt werden.

Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO 11979-7:2001, modifié)

Pour les investigations cliniques de dispositifs médicaux destinés aux sujets humains, les exigences de l'EN 540 s'appliquent. Cette partie de l'EN XXXXX définit les exigences particulieres s'appliquant aux protocoles d'investigation clinique pour les LIOs monofocales de chambre antérieure et postérieure utilisées pour corriger l'aphaquie.

Očesni vsadki (implantati) - Intraokularne leče - 7. del: Klinične raziskave (ISO 11979-7:2001, spremenjen)

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2002
• Withdrawal Date: 30-Jun-2006
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Jul-2006
• Due Date: 01-Jul-2006
• Completion Date: 01-Jul-2006
• Ref Project: EN 13503-7:2001 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2001, modified)

Relations

• Replaced By: SIST EN ISO 11979-7:2006 - Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006)
• Effective Date: 01-Jul-2006

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13503-7:2002
01-maj-2002
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO.OLQLþQHUD]LVNDYH,62
VSUHPHQMHQ
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
SIST EN 13503-7:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 13503-7:2002

---------------------- Page: 2 ----------------------

SIST EN 13503-7:2002
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.

---------------------- Page: 3 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001 (E)
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
2

---------------------- Page: 4 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001(E)
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.
3

---------------------- Page: 5 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001 (E)
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).
4

---------------------- Page: 6 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001(E)
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
5

---------------------- Page: 7 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001 (E)
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
enrolment in the clinical investigation.
5.2.1   In addition to the requirements given in 5.5 of ISO 14155:1996, 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.
NOTE The published national study of cataract surgery in the United Kingdom may provide useful guidance on clinical
performance of IOLs at periods corresponding with the early post-operative case report forms (see references [2] and [3]).
4.6    Addition (see 5.2.2 of ISO 11979-7:2001):
Addition:
The safety and effectiveness of an IOL model shall be established through either:
In addition to the requirements given in 5.6 of ISO 14155:1996, the safety and effectiveness of an IOL
5.2.2
model shall be established through either:
6

---------------------- Page: 8 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001(E)

a clinical investigation conducted in accordance with this part of EN 13503 ISO 11979; or

a comparison of the model characteristics that establish the model as a minor modification of a parent model
for which the safety and effectiveness has been established through clinical investigation in accordance with
this part of EN 13503 ISO 11979.
NOTE     Annex B provides guidance in determining if a modification is minor by providing examples of modifications that
have historically been considered minor.
For the IOL intended for correction of aphakia in a general adult population, a clinical investigation shall either be
developed using the protocol elements provided in annex C or a sponsor shall develop an equivalent protocol that
shall have a similar statistical power to detect differences in adverse event and visual acuity rates between the test
population and a concurrent control population. Subjects implanted with a parent IOL that has met the require-
ments of all parts of EN 13503 and EN ISO 11979 may be used as a control population.
In the case of IOLs designed for either chamber, a separate clinical investigation shall be performed to assess the
clinical performance of the IOL in each chamber.
5.2.3  In addition to the requirements given in 5.7 of ISO 14155:1996, 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 those whose IOL was removed or replaced, have
reached the final reporting period.
5 6 Methodology
5.1 General
The requirements given in 5.1 of EN 540:1993 shall apply.
6.1 Documentation
The requirements given in 6.1 of ISO 14155: 1996 shall apply.
5.2 Requirements before commencement of the clinical investigation
The requirements given in 5.2 of EN 540:1993 shall apply.
6.2 Access to information
The requirements given in 6.2 of ISO 14155:1996 shall apply.
6.3 Additional health care
The requirements given in 6.3 of ISO 14155: 1996 shall apply.
5.3 6.4 Clinical investigation plan
5.3.1 6.4.1 General requirements
The requirements given in 5.3 of EN 540:1993 6.4 of ISO 14155:1996 shall apply.
5.3.2 6.4.2 Additional requirements
The following additional requirements shall apply.
The investigational lens shall only be implanted in a single eye of each subject.
7

---------------------- Page: 9 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001 (E)
5.3.5 Addition (see 5.2.3 of ISO 11979-7:2000):
All subjects in a clinical investigation shall be monitored for the duration of the investigation. The clinical investiga-
tion shall be considered completed when all subjects that have been enrolled in the investigation have completed
the final reporting period of the investigation.
5.3.6 Addition:
The data from all subjects shall be reported including the data from subjects whose IOL was removed or replaced.
The investigational lens shall only be implanted in a single eye of each subject.
5.3.7 Addition:
The clinical performance of the IOL in terms of visual acuity and adverse event rates shall be evaluated.
5.3.11 Addition:
At least the minimum sample size required by the study shall be included in the clinical investigation for each
reporting period. The sponsor shall ensure a sufficient number of subjects in the clinical investigation so that the
minimum number required by the investigation at each reporting period is reached. Each subject has to be
monitored for the duration of the investigation. The investigation is not completed until the last subject has reached
the final reporting period.
NOTE Examples of pre-operative, operative and post-operative case report forms are included in annex C.
5.4 6.5 Role of sponsor
The requirements given in 5.4 of EN 540:1993 6.5 of ISO 14155:1996 shall apply.
5.5 6.6 Role of monitor
The requirements given in 5.5 of EN 540:1993 6.6 of ISO 14155:1996 shall apply.
5.6 6.7 Role of clinical investigator
6.7.1    General requirements
The requirements given in 5.6 of EN 540:1993 6.7 of ISO 14155:1996 shall apply.
6.7.2    Additional requirements
The following additional requirements shall apply.
Clinical investigators shall file adverse event reports of serious adverse events with the sponsor immediately after
learning of their occurrence. Other adverse events shall be reported on the case report forms.
6 7 Presentation of results
The results shall be presented as specified in clause 6 of EN 540:1993 clause 7 of ISO 14155:1996.
8

---------------------- Page: 10 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001(E)
Annex A
(normative)
Selected definitions
To facilitate the understanding of this part of EN 13503 ISO 11979, selected definitions are reproduced in this
annex. In the case of discrepancy, the definitions of EN ISO 11979-1 take precedence over those given here.
A.1
best-case subject
subject with no pre-operative pathology
A.2
cumulative adverse events
total number of adverse events which have occurred at any time up to a specified time point post-operatively
A.3
intraocular lens model
identification by which the features of an intraocular lens, including those of its body and its loops, and the
material(s) used in its construction, have been fully specified
NOTE 1 Examples of body features are body diameter, optic diameter, optic shape factor; examples of loop features are
configuration, calibre, angulation.
NOTE 2 Any significant change in the specification of the materials (including their formulation or synthesis procedures)
results in it being considered a new model.
A.4
level A modification of a parent intraocular lens model
modifications of a parent model which are considered minor and are not expected to result in any safety hazards or
loss in effectiveness when compared to the parent model
A.5
level B modification of a parent intraocular lens model
modifications of a parent model which are greater than level A modifications
NOTE Level B modifications may present a safety hazard or loss of effectiveness concerns which result in a new model that
is significantly different from the parent model.
A.6
lost to follow-up
describing a subject for whom the final post-operative case report form is overdue and who cannot be contacted
despite extensive written and telephone follow-ups to determine the final clinical outcome
NOTE This category does not include subjects who have died.
A.7
optic shape factor
term describing the curvatures of the refracting surfaces of the optic (e.g., plano-convex, bi-convex)
A.8
parent intraocular lens model
intraocular lens model that a sponsor has qualified based on a clinical investigation of at least 100 subjects and
which has met the requirements of all parts of ISO 11979
A.9
persistent adverse event
adverse event which is present at the conclusion of a clinical investigation
9

---------------------- Page: 11 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001 (E)
Annex B
(informative)
Examples of modifications of a parent IOL model
B.1 Design/material modifications of an IOL model
B.1.1 General
Modifications to an IOL that has previously undergone a clinical investigation by the sponsor have different
requirements depending on the magnitude of the modifications. Two levels of modifications have historically been
associated with a parent IOL: Level A and Level B. Examples of Level A and Level B modifications are given in B.2.
B.1.2 Level A
Level A modifications of a parent model in almost all cases do not require a clinical investigation. A case where a
clinical investigation of a Level A modification of a parent model should be performed is if the modified model poses
additional clinical questions which cannot be adequately addressed by preclinical testing, such as potential tissue
damage associated with a modification in implantation technique necessitated by the modified design.
A Level A modification of a parent IOL usually does not itself become a parent IOL for subsequent modifications.
The only case where it may is described below.
If a model is still under clinical investigation, Level A modified versions of that model may be introduced into the
clinical investigation of the model and the data from the original investigational model and the Level A modified
model(s) may be combined, except in the case of those Level A changes that involve material substitutions from
parent models (i.e., modifications described in B.2.2.12).
A Level A modified IOL which was added to the clinical investigation of the investigational model may only itself be
considered a parent IOL at the conclusion of the study if that Level A modified model was investigated in a
minimum of 100 subjects at each case report form, it met the requirements of all parts of ISO 11979, and if the
results of a clinical analysis indicate that there is no significant difference between its clinical performance and the
clinical performance of the other investigational models in the clinical investigation.
B.1.3 Level B
The clinical investigation of new IOLs that are Level B modifications of a parent model should include a minimum of
100 subjects monitored up to case report form 4 (case report forms are defined in Annex C).
The minimum number of case report forms for each visit should be 100. The sponsor should anticipate needing to
enrol 125 subjects to take into account the subjects that are lost or die in the course of the clinical investigation.
The sample size required for the Level B clinical investigation is the minimum number necessary to detect a
clinically significant difference in adverse event and visually acuity rates between the IOL under investigation and
the rates associated with the historical control population. If the sponsor chooses to compare the performance of
their IOL to a concurrently run control population, the sponsor should enrol sufficient subjects such that the ability of
the study to detect changes in visual acuity and adverse event rates are equivalent to the ability associated with the
study which compares the IOL to the historical control population.
The lost to follow-up subjects in the Level B investigation should be less than 10 %. Each investigator should have
a minimum of 20 subjects, and no more than 25 % of the subjects in the investigation. The Level B clinical investi-
gation should be considered completed when all subjects that have been enrolled in the investigation have reached
case report form 4.
A Level B modified IOL may only itself be considered a parent IOL at the conclusion of the study if it was
investigated in a minimum of 100 subjects at each case report form (therefore the model could not have been
combined with Level A modifications of itself in the clinical study), and it met the requirements of all parts of
ISO 11979.
10

---------------------- Page: 12 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001(E)
B.2 Examples of IOL modifications
B.2.1 General
Modifications to an IOL that has undergone a clinical investigation can be classified in one of two categories
depending on the level of modification: Level A or Level B. The criteria that are to be used to determine what level
of modification has occurred to the parent model are described below.
The applicability column indicates the type of IOL that the modification is allowed with:
P   designates polymethylmethacrylate (PMMA) posterior chamber IOLs
A   designates PMMA anterior chamber IOLs
SP  designates posterior chamber IOLs made from soft materials that are of a one-piece, plate design (no loops)
SS  designates multi-piece, posterior chamber IOLs with optics made of soft materials and loops made from standard material
(PMMA, polypropylene, or polyimide)
SN  designates multi-piece, posterior chamber IOLs with optics made of soft materials and loops made from non-standard
materials
A modified model may have various combinations of the modifications listed below as long as all of the required
criteria are met (e.g., the modified model may have a larger optic, with a slightly modified loop configuration and a
larger overall diameter than the parent model). Modification B.2.2.12 differs from the other modifications in that it
involves material/design substitutions of parent models only.
B.2.2 Level A modifications (see B.2.1 for P, A etc.)
B.2.2.1     Mirror-image version of a model
Applicability is P/A/SP/SS/SN
B.2.2.2     Change in overall diameter
Applicability in the case of the addition of a size specific to patients with a certain anterior chamber width range is
A.
B.2.2.3     Changes in loop features
Applicability in the case of changes such as the addition of notches, or the addition of small loops or rounded ends
to loops is P/A/SS/SN.
B.2.2.4     Change in loop angulation
Applicability in the case of a change from planar to a design with the body angulated posterior to loops resulting in
an increase in the sagitta value up to a maximum of 1,6 mm for the 20 D version of the model is P/SS/SN.
B.2.2.5     Change in loop configuration, in loop thickness or width (calibre)
B.2.2.5.1   General
Applicability is P/SS/SN.
To determine if these changes result in modified lenses, which are Level A modifications of the parent lenses, an
analysis of the change in mechanical properties that has occurred as a result of the modification is required.
The sponsor should be aware that loop modifications of a model that have satisfied the requirements of this part of
ISO 11979 should not be considered Level A modifications (even if the results of the required mechanical testing
qualify them as such) if the modified model poses additional clinical questions that cannot be adequately
addressed by preclinical testing (such as potential tissue damage associated with a modification in implantation
technique necessitated by the new design).
11

---------------------- Page: 13 ----------------------

SIST EN 13503-7:2002
EN 13503-7:2001 (E)
Two methods of comparing the mechan
...