SIST EN ISO 10340:2000

SLOVENSKI STANDARD
SIST EN ISO 10340:2000
01-januar-2000
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Optics and optical instruments - Contact lenses - Method for determining the extractable
substances (ISO 10340:1995)
Optik und optische Instrumente - Kontaktlinsen - Prüfverfahren zur Bestimmung
extrahierbarer Anteile (ISO 10340:1995)
Optique et instruments d'optique - Lentilles de contact - Méthode pour la détermination
des substances extractibles (ISO 10340:1995)
Ta slovenski standard je istoveten z: EN ISO 10340:1996
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 10340:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10340:2000

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SIST EN ISO 10340:2000

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SIST EN ISO 10340:2000

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SIST EN ISO 10340:2000

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SIST EN ISO 10340:2000

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SIST EN ISO 10340:2000
INTERNATIONAL
ISO
STANDARD
10340
First edition
1995-08-01
Optics and Optical instruments - Contact
lenses - Method for determining the
extractable substances
Optique et instruments d’optique - Lentilles de contact - Methode
pour Ia determination des substances extractibles
Reference number
ISO 10340:1995(E)

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SIST EN ISO 10340:2000
ISO 10340:1995(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. Esch 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 10340 was prepared by Technical Committee
lSO/TC 172, Optics and Optical instruments, Subcommittee SC 7, Optics
and oph thalmic ins trumen ts.
Annex A of this International Standard is for information only.
0 ISO 1995
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronie or mechanical, including photocopying and
microfilm, without Permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland

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SIST EN ISO 10340:2000
ISO 10340:1995(E)
INTERNATIONAL STANDARD 0 ISO
- Contact lenses -
Optics and Optical instruments
Method for determining the extractable substances
contact lens material. However, in the development of new
1 Scope
contact lens materials, a solvent that Causes reversible
swelling may give valuable information relating to the
This International Standard specifies an analytical
possibility for extraction over extended periods of time.
method for the quantitative determination of the sub-
stances extractable from contact lenses by Soxhlet
2 A knowledge of the quantity and identity of extractable
extraction with different solvents. substances is of particular help in evaluating new contact
lens materials, and determining the subsequent pre-clinical
examination Programme. The material extracted from the
2 Normative reference
contact lenses may be examined by appropriate chromato-
graphic, spectrophotometric and wet analysis methods, to
The following Standard contains provisions which,
identify residual monomers, Cross-linking agents and cata-
through reference in this text, constitute provisions
lysts that were employed in the polymerization process.
of this International Standard. At the time of publi-
cation, the edition indicated was valid. All Standards 3 The laboratory carrying out this test should follow the
OECD guidelines for “Good Laboratory Practice in the
and Parties to agreements
are subject to revision,
Testing of Chemicals”. Any deviation should be clearly
based on this International Standard are encouraged
stated in the test report.
to investigate the possibility of applying the most re-
cent edition of the Standard indicated below. Mem-
bers of IEC and ISO maintain registers of currently
valid International Standards. 4 Reagents
ISO 3696: 1987, Water for analytical laboratory use -
4.1 Water, distilled or deionized, complying with
Specifica tion and test me thods.
grade 3 of ISO 3696.
3 Principle 4.2 Organic solvent, analytical grade (see table 1).
The contact lenses are extracted with various solvents
4.3 Boiling stones or anti-bumping granules, lab-
by Soxhlet extraction. The lenses are dried to constant
oratory grade.
mass and the differente between the original dry
mass of the lens and the extracted dry mass deter-
4.4 Active desiccant.
mines the quantity of extractable substances.
NOTE 4
Selection of a suitable desiccant will depend
NOTES
upon the characteristics of the test material.
1 The method of extraction specified in this International
Standard uses the normal Soxhlet apparatus. However, it
describes the particular precautions necessary when hand-
5 Apparatus
ling contact lenses, and also gives guidance to the range of
solvents that may be employed. Water and at least one
5.1 Soxhlet extraction apparatus, comprising a
suitable organic solvent are used for extraction. In selecting
round-botto
...