EN ISO 18369-4:2017

SLOVENSKI STANDARD
01-november-2017
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SIST EN ISO 18369-4:2006
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Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens
materials (ISO 18369-4:2017)
Augenoptik - Kontaktlinsen - Teil 4: Physikalisch-chemische Eigenschaften von
Kontaktlinsenmaterialien (ISO 18369-4:2017)
Optique ophtalmique - Lentilles de contact - Partie 4: Propriétés physicochimiques des
matériaux des lentilles de contact (ISO 18369-4:2017)
Ta slovenski standard je istoveten z: EN ISO 18369-4:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18369-4
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 18369-4:2006
English Version
Ophthalmic optics - Contact lenses - Part 4:
Physicochemical properties of contact lens materials (ISO
18369-4:2017)
Optique ophtalmique - Lentilles de contact - Partie 4: Augenoptik - Kontaktlinsen - Teil 4: Physikalisch-
Propriétés physicochimiques des matériaux des chemische Eigenschaften von
lentilles de contact (ISO 18369-4:2017) Kontaktlinsenmaterialien (ISO 18369-4:2017)
This European Standard was approved by CEN on 1 July 2017.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18369-4:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18369-4:2017) 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 March 2018, and conflicting national standards shall
be withdrawn at the latest by March 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18369-4:2017.
According to the CEN-CENELEC Internal Regulations, the national standards organizations 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 18369-4:2017 has been approved by CEN as EN ISO 18369-4:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 18369-4
Second edition
2017-08
Ophthalmic optics — Contact lenses —
Part 4:
Physicochemical properties of contact
lens materials
Optique ophtalmique — Lentilles de contact —
Partie 4: Propriétés physicochimiques des matériaux des lentilles
de contact
Reference number
ISO 18369-4:2017(E)
©
ISO 2017
ISO 18369-4:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

ISO 18369-4:2017(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Physicochemical properties of contact lenses . 1
4.1 Repeatability, test methods and units of measure . 1
4.2 Extractables . 2
4.2.1 General. 2
4.2.2 Principle . 2
4.2.3 Apparatus . 2
4.2.4 Reagents . 3
4.2.5 Test samples. 4
4.2.6 Test procedure . 4
4.2.7 Calculation of results . 5
4.2.8 Test report . 5
4.3 Rigid lens flexural deformation and rupture . 5
4.3.1 Principle . 5
4.3.2 Sampling. 5
4.3.3 Preparation of samples . 6
4.3.4 Apparatus . 6
4.3.5 Procedure . 8
4.3.6 Test result . . 8
4.4 Oxygen permeability . 9
4.4.1 General. 9
4.4.2 Common elements of the methods . 9
4.4.3 Polarographic method . .10
4.4.4 Normalization of the corrected oxygen permeability using reference lenses .18
4.4.5 Test report .19
4.5 Refractive index .19
4.5.1 General.19
4.5.2 Abbe refractometer .19
4.5.3 Test samples.20
4.5.4 Procedure .20
4.5.5 Expression of test results .21
4.5.6 Test report .21
4.6 Water content .22
4.6.1 General.22
4.6.2 Gravimetric determination of water content/absorption by loss on drying
using an oven .22
4.6.3 Test report .24
5 Test report .24
Annex A (informative) Determination of oxygen permeability using the coulometric method .25
Annex B (informative) Determination of water content by refractive index .32
Annex C (informative) Calculation of oxygen permeability of hydrogel lenses based on
water content .33
Annex D (informative) Measurement of refractive index using a prism coupling device .34
Bibliography .36
ISO 18369-4:2017(E)
Foreword
ISO (the International Organization
...