SIST EN ISO 9394:2013

SLOVENSKI STANDARD
SIST EN ISO 9394:2013
01-januar-2013
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SIST EN ISO 9394:2000
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Ophthalmic optics - Contact lenses and contact lens care products - Determination of
biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der
Biokompatibilität durch Erprobung am Kaninchenauge (ISO 9394:2012)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Détermination de la biocompatibilité par évaluation de la tolérance oculaire chez le
lapin (ISO 9394:2012)
Ta slovenski standard je istoveten z: EN ISO 9394:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 9394:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9394:2013

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SIST EN ISO 9394:2013


EUROPEAN STANDARD
EN ISO 9394

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2012
ICS 11.040.70 Supersedes EN ISO 9394:1998
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Determination of biocompatibility by ocular study with
rabbit eyes (ISO 9394:2012)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien pour lentilles de contact - Détermination de la Bestimmung der Biokompatibilität durch Erprobung am
biocompatibilité par évaluation de la tolérance oculaire chez Kaninchenauge (ISO 9394:2012)
le lapin (ISO 9394:2012)
This European Standard was approved by CEN on 30 September 2012.

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 CEN-CENELEC 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 CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9394:2012: E
worldwide for CEN national Members.

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SIST EN ISO 9394:2013
EN ISO 9394:2012 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 9394:2013
EN ISO 9394:2012 (E)
Foreword
This document (EN ISO 9394:2012) has been prepared by Technical Committee ISO/TC 172 "Optics and
photonics" 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 April 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9394:1998.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9394:2012 has been approved by CEN as a EN ISO 9394:2012 without any modification.
3

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SIST EN ISO 9394:2013

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SIST EN ISO 9394:2013
INTERNATIONAL ISO
STANDARD 9394
Third edition
2012-10-01
Ophthalmic optics — Contact lenses
and contact lens care products —
Determination of biocompatibility by
ocular study with rabbit eyes
Optique ophtalmique — Lentilles de contact et produits d’entretien
pour lentilles de contact — Détermination de la biocompatibilité par
évaluation de la tolérance oculaire chez le lapin
Reference number
ISO 9394:2012(E)
©
ISO 2012

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SIST EN ISO 9394:2013
ISO 9394:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 9394:2013
ISO 9394:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Animals and husbandry . 1
6 Reagents/materials . 2
7 Apparatus . 2
8 Test specimens . 3
8.1 Lens parameters . 3
8.2 Preparation and storage . 3
9 Test procedure . 3
9.1 Preliminary examination of animals . 3
9.2 Insertion and removal of test lens . 4
9.3 Examination of the rabbit’s eye . 4
9.4 Weighing of animals . 4
9.5 Histological examination . 5
9.6 Corneal metabolism . 5
10 Assessment of results . 5
11 Test report . 5
Annex A (normative) McDonald-Shadduck score system — Slit lamp . 7
Annex B (normative) Draize scale for scoring ocular lesions . 11
Bibliography .13
© ISO 2012 – All rights reserved iii

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SIST EN ISO 9394:2013
ISO 9394:2012(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 9394 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 9394:1998), which has been technically revised.
iv © ISO 2012 – All rights reserved

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SIST EN ISO 9394:2013
ISO 9394:2012(E)
Introduction
The ocular tissue of the rabbit is traditionally used to evaluate the irritant properties of materials which come
in contact with ocular tissue.
The use of the device under evaluation is governed by the nature, degree, duration, frequency and conditions
of exposure of humans to the device in normal intended use.
It is incumbent upon the investigator to conduct such evaluations using good scientific laboratory practices,
complying with regulations related to animal welfare and the general principles set forth in the normative references.
ISO 10993-1 is the basic horizontal International Standard for biological evaluation of medical devices, and
serves as a framework for planning biological evaluation tests.
ISO 10993-10 assesses possible contact hazards from device-released chemicals that may produce skin and
mucosal irritation, eye irritation and delayed contact sensitization.
Usage tests for specific devices are defined in vertical standards. This International Standard describes one of
several specific usage tests for contact lenses and contact lens care products.
The existence of this International Standard does not imply that rabbit-eye testing is a requirement in the
determination of biocompatibility of contact lenses and contact lens care products, nor that this test is sufficient
by itself to determine the biocompatibility of contact lenses and contact lens care products. Taking into
consideration animal welfare requirements (ISO 10993-2), it is recommended that this in vivo test be carried
out after obtaining data of in vitro toxicological testing such as that described in ISO 10993-5.
Care should be taken when extrapolating the test results to the human eye.
© ISO 2012 – All rights reserved v

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SIST EN ISO 9394:2013

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SIST EN ISO 9394:2013
INTERNATIONAL STANDARD ISO 9394:2012(E)
Ophthalmic optics — Contact lenses and contact lens care
products — Determination of biocompatibility by ocular study
with rabbit eyes
1 Scope
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact
lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue
produced by the device under test. The test method is described in application to rabbit eyes.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
OECD 1997, OECD Principles of Good Laboratory Practice, No.1
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 apply.
4 General requirements
The general principles for biological evaluation and categorization of medical devices given in ISO 10993-1
shall apply. The study shall be performed in accordance with ISO/IEC 17025 and Good Laboratory Practice
(GLP) (OECD, Principles of Good Laboratory Practice, No.1).
Tests for irritation and sensitization of contact lenses and contact lens care products shall be carried out in
accordance with ISO 10993-10.
The assessment of the results shall be carried out by appropriately experienced and competent personnel.
5 Animals and husbandry
5.1 New Zealand white strain rabbits (male, female or mixed sexes) or equivalent albino rabbits shall be used
to test each type of contact lens or lens care product. They shall be healthy young adults from a single strain
© ISO 2012 – All rights reserved 1

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SIST EN ISO 9394:2013
ISO 9394:2012(E)
from a single recognized source weighing > 2,5 kg. They shall have eyes free from clinically significant ocular
irritation or corneal retention of fluorescein stain.
A minimum number of three rabbits shall be used, however a number of six is recommended to ensure an
acceptable level of precision of the test results. If less than six rabbits are used, then the quantity shall be justified.
If control articles are included in the evaluation, use the contra-lateral eye or an additional group of animals
with the same number of animals chosen as before for each control article. For contact lens care products,
the control group should use the same type of contact lens which has not been treated with the test product.
Positive controls shall not be used.
NOTE In this context, “control article“ should be interpreted as being a device with defined safety and performance
characteristics.
5.2 The animal welfare requirements set out in ISO 10993-2 shall be met.
5.3 The animals shall be housed individually and have free access to commercially pelted rabbit feed and tap
water. Group housing is not feasible in this test since any lens found expulsed from the eye shall be matched to
the specific rabbit which wore the lens and re-inserted into the same eye.
5.4 Each animal shall be identified by one of the following:
a) a numbered ear tag;
b) a tattoo;
c) a microchip; or
d) a permanent ink marking.
The animals shall be acclimatized to the laboratory conditions for at least five days prior to testing.
5.5 The nictitating membrane should not be removed from the rabbits’ eyes, and the eyelids should not be
sutured during lens wear. Any deviations shall be justified and documented in the test report.
NOTE The albino rabbit eye is free of pigment, easily examined and has historically been used for ocular irritation studies.
All appropriate regulatory requirements governing the care and use of animals shall be followed.
5.6 During daily treatment, the rabbits shall be minimally restrained.
6 Reagents/materials
6.1 Sodium fluorescein, as specified by an appropriate pharmacopoeia.
NOTE Attention should be made to the degree of staining and the concentration of fluorescein administered to the
eye (e.g. 3 μl of 1 % fluorescein in saline solution).
6.2 Contact lens care products, as recommended by the manufacturers.
6.3 Contact lenses, as recommended by the manufacturer.
7 Apparatus
7.1 Slit lamp microscope, with appropriate filters.
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SIST EN ISO 9394:2013
ISO 9394:2012(E)
7.2 Magnifying glass, of minimum magnification 6×.
7.3 Balance or weighing machine, capable of weighing up to 5 kg to an accuracy of 100 g.
8 Test specimens
8.1 Lens parameters
Contact lenses shall be sufficiently thick to represent either
a) reasonable human use extremes; or
b) the extreme of the manufacturer’s product line.
The contact lens selected shall produce a good fit to a rabbit eye.
NOTE This is necessary to minimize physical irritation and expulsion. In the case where this thickness does not allow
a good fit of the contact lens, a contact lens of the greatest thickness which allows a good fit should be used.
Contact lens parameters shall be documented in the final report.
8.2 Preparation and storage
If contact lens care
...