EN ISO 18369-1:2017

SLOVENSKI STANDARD
01-november-2017
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SIST EN ISO 18369-1:2006
SIST EN ISO 18369-1:2006/A1:2009
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Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and
recommendations for labelling specifications (ISO 18369-1:2017)
Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und
Empfehlungen für die Schreibweise von Kontaktlinsenspezifikationen (ISO 18369-
1:2017)
Optique ophtalmique - Lentilles de contact - Partie 1: Vocabulaire, système de
classification et recommandations pour l'étiquetage des spécifications (ISO 18369-
1:2017)
Ta slovenski standard je istoveten z: EN ISO 18369-1:2017
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18369-1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 18369-1:2006
English Version
Ophthalmic optics - Contact lenses - Part 1: Vocabulary,
classification system and recommendations for labelling
specifications (ISO 18369-1:2017)
Optique ophtalmique - Lentilles de contact - Partie 1: Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung
Vocabulaire, système de classification et von Kontaktlinsenmaterialien und Empfehlungen für
recommandations pour l'étiquetage des spécifications die Schreibweise von Kontaktlinsenspezifikationen
(ISO 18369-1:2017) (ISO 18369-1:2017)
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 18369-1:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 18369-1:2017) 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 18369-1:2006.
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 18369-1:2017 has been approved by CEN as EN ISO 18369-1:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 18369-1
Second edition
2017-08
Ophthalmic optics — Contact lenses —
Part 1:
Vocabulary, classification system
and recommendations for labelling
specifications
Optique ophtalmique — Lentilles de contact —
Partie 1: Vocabulaire, système de classification et recommandations
pour l’étiquetage des spécifications
Reference number
ISO 18369-1:2017(E)
©
ISO 2017
ISO 18369-1:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

ISO 18369-1:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 Terms and definitions . 1
3.2 Symbols .38
4 Classification of contact lens materials .39
Annex A (informative) Specification of rigid contact lenses .42
Annex B (informative) Specification of soft contact lenses .52
Bibliography .54
Alphabetical index of terms .56
ISO 18369-1:2017(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 second edition cancels and replaces the first edition (ISO 18369-1:2006), which has been
technically revised. It also incorporates the Amendment ISO 18369-1:2006/Amd 1:2009.
A list of all parts in the ISO 18369 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

ISO 18369-1:2017(E)
Introduction
The ISO 18369 series applies to contact lenses, which are devices worn over the front surface of the eye
in contact with the preocular tear film. This document covers rigid (hard) corneal and scleral contact
lenses, as well as soft contact lenses. Rigid lenses maintain their own shape. Soft contact lenses are
easily deformable and require support for proper shape.
Clause 3 contains the terms and definitions primarily used in the contact lens field. A list of terms
having special symbols is given in Table 1.
The list of terms and definitions does not include all ISO terms, definitions, and symbols used in the
contact lens field. It is intended to be a convenient reference source from which the contents have
been compiled from the text of this and other ISO standards applicable to the manufacture, evaluation,
measurement, labelling and marketing of contact lenses and contact lens care products. An alphabetical
index was added for rapid finding of terms.
Words are grouped under several topics by reference number according to the general category into
which each word logically fits. The preferred form of each term is listed on the first line after its
reference number. Other admitted forms have been placed on subsequent lines after the preferred
form. All admitted terms are given in bold-faced type. A few obsolete and superseded terms are listed
for historical reference and convenience and to aid comprehension but are indicated as deprecated and
are no longer to be used. Obsolete and superseded terms are not in bold-faced type so that they may be
clearly identified as terms used historically.
Contact lenses are primarily used for the correction of refractive errors but they can also be used for
therapeutic purposes and cosmetic reasons. The materials used are divided into two main categories,
rigid and soft. The former is composed mainly of corneal lenses and to a lesser extent, scleral lenses.
Both types can be made from gas-permeable materials or non-gas permeable materials. Soft lenses are
manufactured primarily from hydrogel materials. A small number of lenses incorporate both a rigid
material and a soft material.
In terms of vision correction, contact lenses can be made as single vision, bifocal, multifocal or
progressive lenses. Surface designs can be spherical, aspheric, toric or “complex”.
Wearing modality can be daily wear, flexible wear, or extended wear. Typical replacement schedules for
soft lenses are daily, two weekly, or monthly. Rigid lenses and some soft lenses are replaced less often,
for example, once a year.
INTERNATIONAL STANDARD ISO 18369-1:2017(E)
Ophthalmic optics — Contact lenses —
Part 1:
Vocabulary, classification system and recommendations for
labelling specifications
1 Scope
This document identifies and defines the terms applicable to the physical, chemical and optical properties
of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate,
the international symbol and abbreviation associated with a s
...