EN ISO 18369-2:2017

Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)

ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture.
These tolerances might not apply to other purposes, for example, shelf-life studies.

Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2017)

Dieser Teil von ISO 18369 legt die Grenzabmaße bzw. Grenzabweichungen für die optischen und physikali-schen Eigenschaften von formstabilen Korneal- und formstabilen Skleral- und weichen Kontaktlinsen zum Zeitpunkt der Herstellung fest.
Diese Grenzabmaße bzw. Grenzabweichungen können nicht für andere Zwecke, wie z. B. Haltbarkeitsstudien, angewendet werden,

Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2017)

ISO 18369-2:2017 spécifie les limites de tolérance des principaux paramètres optiques et physiques des lentilles de contact cornéennes rigides, sclérales rigides et souples au moment de leur fabrication.
Ces tolérances peuvent ne pas s'appliquer à d'autres fins, par exemple, à des études de durée de conservation.

Očesna optika - Kontaktne leče - 2. del: Tolerance (ISO 18369-2:2017)

Ta dokument določa tolerančne meje glavnih optičnih in fizikalnih parametrov trdih roženičnih, trdih beločničnih in mehkih kontaktnih leč med izdelavo.
Te tolerance se morda ne uporabljajo za druge namene, na primer za študije roka uporabnosti.

General Information

• Status: Published
• Publication Date: 19-Sep-2017
• Withdrawal Date: 30-Mar-2018
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Sep-2017
• Completion Date: 20-Sep-2017
• Ref Project: SIST EN ISO 18369-2:2017 - Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)

Relations

• Replaces: EN ISO 18369-2:2012 - Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012)
• Effective Date: 27-Sep-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 18369-2:2013
2þHVQDRSWLND.RQWDNWQHOHþHGHO7ROHUDQFH,62
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2017)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2017)
Ta slovenski standard je istoveten z: EN ISO 18369-2:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18369-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 01.040.11; 11.040.70 Supersedes EN ISO 18369-2:2012
English Version
Ophthalmic optics - Contact lenses - Part 2: Tolerances
(ISO 18369-2:2017)
Optique ophtalmique - Lentilles de contact - Partie 2: Augenoptik - Kontaktlinsen - Teil 2:
Tolérances (ISO 18369-2:2017) Grenzabweichungen (ISO 18369-2:2017)
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 18369-2:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 18369-2:2017) 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 18369-2:2012.
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 18369-2:2017 has been approved by CEN as EN ISO 18369-2:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 18369-2
Third edition
2017-08
Ophthalmic optics — Contact lenses —
Part 2:
Tolerances
Optique ophtalmique — Lentilles de contact —
Partie 2: Tolérances
Reference number
ISO 18369-2:2017(E)
©
ISO 2017
ISO 18369-2:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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ii © ISO 2017 – All rights reserved

ISO 18369-2:2017(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 1
4.1 Tolerance limits for contact lenses . 1
4.2 Conformance criteria for testing products . 2
4.3 Conditioning of contact lenses prior to testing . 2
4.4 Transmittance of ultraviolet radiation . 2
4.5 Requirements for finish . 2
4.5.1 Inclusions and surface imperfections . 2
4.5.2 Fenestrations. 2
4.5.3 Edge contour and finish . 2
4.6 Additional properties . 2
5 Tolerances for rigid contact lenses. 2
6 Tolerances for soft contact lenses . 4
Bibliography . 7
ISO 18369-2:2017(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document 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 18369-2:2012), which has been
technically revised.
A list of all parts in the ISO 18369 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 18369-2:2017(E)
Ophthalmic optics — Contact lenses —
Part 2:
Tolerances
1 Scope
This document specifies the tolerance limits of the principal optical and physical parameters of rigid
corneal, rigid scleral and soft contact lenses at the time of manufacture.
These tolerances might not apply to other purposes, for example, shelf-life studies.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification systems and
recommendations for labelling specifications
ISO 18369-3:2017, Ophthalmic optics — Contact lenses — Part 3: Measurement methods
ISO 18369-4:2017, Ophthalmic optics — Contact lenses — Part 4: Physicochemical properties of contact
lens materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
4 General
4.1 Tolerance limits for contact lenses
When tested as described in ISO 18369-3, the dimensional and optical properties for contact lenses
shall be as specified within the appropriate tolerance limits given in Table 1, Table 2 and Table 3.
When tested as described in ISO 18369-4, the material properties for contact lenses shall be as specified,
within the appropriate tolerance limits given in Table 4.
ISO 18369-2:2017(E)
4.2 Conformance criteria for testing products
There are three meaningful methods to determine the conformance of contact lens parameters to
specified tolerances:
a) 100 % inspection — a method to determine conformance to a specified value, including tolerances
based on evaluation of each item in the population to be evaluated;
b) acceptance sampling — a method to assign a product to a specified conformance level
(e.g. acceptance quality limit and limiting quality);
c) statistical estimation of performance — process assessment where a representative sample is
determined and used to estimate performance.
Conformance can be based on supplier data for lens lots supplied or third-party audits.
4.3 Conditioning of contact lenses prior to testing
Contact lenses shall be equilibrated in standard saline or packaging solution, unless otherwise specified
in the relevant test method specified in ISO 18369-3 or ISO 18369-4.
4.4 Transmittance of ultraviolet radiation
For contact lenses claimed to attenuate ultraviolet radiation, total transmittance of ultraviolet
radiation through the contact lens shall conform to those amounts specified in Table 4. Such lenses
shall be categorized as “Class 1” or “Class 2” absorbers, according to the measured ultraviolet radiation
transmittance.
4.5 Requirements for finish
4.5.1 Inclusions and surface imperfections
When examined as specified in
...