SIST EN ISO 11987:2000
(Main)Optics and optical instruments - Contact lenses - Determination of shelf-life (ISO 11987:1997)
Optics and optical instruments - Contact lenses - Determination of shelf-life (ISO 11987:1997)
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:1997)
Diese Internationale Norm beschreibt die Prüfverfahren, die zur Bestimmung der Stabilität von Kontaktlinsen nach deren Verpackung in ihren Endbehälter während der Lagerung und dem Vertrieb, erforderlich sind. ANMERKUNG: Die erzielten Ergebnisse können zur Festlegung des 'Ablaufdatums', bis zu welchem eine 'Erstmalige Anwendung' der Kontaktlinse erfolgen darf, verwendet werden.
Optique et instruments d'optique - Lentilles de contact - Détermination de la durée de conservation (ISO 11987:1997)
La présente Norme internationale décrit les essais permettant de déterminer la stabilité des lentilles de contact lorsqu'elles se trouvent dans leur emballage définitif pendant le stockage et la distribution.
NOTE Les résultats obtenus peuvent être utilisés pour déterminer la «date d'expiration».
Optika in optični instrumenti - Kontaktne leče - Določevanje roka uporabnosti (ISO 11987:1997)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11987:2000
01-januar-2000
2SWLNDLQRSWLþQLLQVWUXPHQWL.RQWDNWQHOHþH'RORþHYDQMHURNDXSRUDEQRVWL ,62
Optics and optical instruments - Contact lenses - Determination of shelf-life (ISO
11987:1997)
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:1997)
Optique et instruments d'optique - Lentilles de contact - Détermination de la durée de
conservation (ISO 11987:1997)
Ta slovenski standard je istoveten z: EN ISO 11987:1997
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11987:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11987:2000
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SIST EN ISO 11987:2000
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SIST EN ISO 11987:2000
INTERNATIONAL ISO
STANDARD 11987
First edition
1997-12-01
Ophthalmic optics — Contact lenses —
Determination of shelf-life
Optique ophtalmique — Lentilles de contact — Détermination de la durée
de conservation
A
Reference number
ISO 11987:1997(E)
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SIST EN ISO 11987:2000
ISO 11987:1997(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.
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.
International Standard ISO 11987 was prepared by ISO/TC 172, Optics and optical instruments,
Ophthalmic optics and instruments.
Subcommittee SC 7,
Annex A of this International Standard is for information only.
© ISO 1997
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 the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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SIST EN ISO 11987:2000
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ISO ISO 11987:1997(E)
Introduction
The tests included in this International Standard are designed to obtain information
that will enable proposals to be made for the shelf-life of the contact lens, and enable
storage conditions to be recommended. However in practical terms it is the stability
of the material from which the contact lens is made that is being tested, along with
the integrity of the packaging that maintains the environment necessary for the
contact lens.
The purpose of the stability studies is to ascertain how the quality of the contact lens
varies as a function of time and under the influence of a variety of environmental
factors. On the basis of the information thus obtained, storage conditions can be
recommended which will guarantee the maintenance of the quality of the contact
lens in relation to its safety, efficacy and acceptability, throughout the proposed shelf-
life (i.e. during storage and distribution until the moment of dispensing).
iii
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SIST EN ISO 11987:2000
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SIST EN ISO 11987:2000
©
INTERNATIONAL STANDARD ISO ISO 11987:1997(E)
Ophthalmic optics — Contact lenses — Determination of
shelf-life
1 Scope
This International Standard describes the testing required in order to determine the
stability of contact lenses, once placed in their final packaging, during storage and
distribution.
NOTE The results obtained can be used for determining the ‘expiry date’.
2 Normative references
The following standards contain provisions which, through reference in this text,
constitute provisions of this International Standard. At the time of publication, the
editions indicated were valid. All standards are subject to revision, and parties to
agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards indicated below.
Members of IEC and ISO maintain registers of currently valid International
Standards.
ISO 8321-1:1991 Optics and optical instruments - Contact lenses - Part 1:
Specification for rigid corneal and scleral contact lenses
Optics and optical instruments - Contact lenses - Determination
ISO 8599:1994
of spectral and luminous transmittances
1
ISO 9337-1:– Ophthalmic optics - Contact lenses - Determination of back
vertex power - Part 1: Focimeter
Optics and optical instruments - Contact lenses - Determination
ISO 9338:1996
of the diameters
ISO 9341:1996 Optics and optical instruments - Contact lenses - Determination
of inclusions and surface imperfections for rigid contact lenses
Optics and optical instruments - Contact lenses - Determination
ISO 10338:1996
of curvature
3 Principle
Suitable tests are described by which the stability of contact lenses under controlled
storage conditions is established and their shelf-life under those conditions
determined.
1
To be published.
1
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SIST EN ISO 11987:2000
©
ISO
ISO 11987:1997(E)
The design of the stability tests is based on the known properties of the material from
which the contact lens is made, and the recommendations for storage of the contact
lens.
NOTE 1 A knowledge of the quantity and identity of extractable substances (see
ISO 10340) is of particular help in evaluating new contact lens materials, and in
determining the information that needs to be obtained from the stability testing.
NOTE 2 The specifications claimed at the time of manufacture and to the end of the
proposed shelf-life should reflect, as far as possible, the results of the stability
studies, particularly in relation to any parameters which could have a bearing on
efficacy, safety and product acceptability.
NOTE 3 In designing stability tests, the manufacturer should consider any sterility
requirement. Validation and requirements of sterilization processes are described in
other International Standards. Additionally, sterility testing is described in
pharmacopoeia monographs.
4 Reagent
The reagent shall be the contact lens storage solution used by the manufacturer for
packing the contact lens.
5 Apparatus
5.1 Controlled storage chamber, capable of being maintained at 25°C ± 2°C,
and equipped with means for continuously recording temperature and humidity.
± ±
NOTE Additional storage conditions, for example at 35°C 2°C and 45°C 2°C,
may be required for accelerated studies.
5.2 Measuring equipment, as required, for the determination of back vertex
power, total diameter, curvature and spectral transmittance. The equipment shall
incorporate, if necessary, the facility to condition the contact lens within the storage
solution before and during measurement, under the controlled conditions specified in
the measurement method.
6 Test samples
6.1 Test lenses shall be representative of the normal production. The parameters
of the contact lenses being studied shall be representative of the range of
parameters normally produced, in particular high and low back vertex powers (see
Table 1). If supplied sterile, the contact lenses shall have been subjected to the
sterilization process normally used.
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SIST EN ISO 11987:2000
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ISO ISO 11987:1997(E)
Table 1 - Suitable parameters for test lenses
Parameter Soft lens Rigid lens
Diameter (see ISO 9338) 12,0 mm to 16,0 mm 8,0 mm to 11,0 mm
Curvature (see ISO 10338) 7,0 mm to 10
...
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