EN ISO 14534:2002

SLOVENSKI STANDARD
SIST EN ISO 14534:2002
01-november-2002
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SIST EN ISO 14534:2000
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental
requirements (ISO 14534:2002)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen
(ISO 14534:2002)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Exigences fondamentales (ISO 14534:2002)
Ta slovenski standard je istoveten z: EN ISO 14534:2002
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 14534:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14534:2002

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SIST EN ISO 14534:2002
EUROPEAN STANDARD
EN ISO 14534
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2002
ICS 11.040.70 Supersedes EN ISO 14534:1997
English version
Ophthalmic optics - Contact lenses and contact lens care
products - Fundamental requirements (ISO 14534:2002)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien des lentilles de contact - Exigences Grundlegende Anforderungen (ISO 14534:2002)
fondamentales (ISO 14534:2002)
This European Standard was approved by CEN on 30 May 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14534:2002 E
worldwide for CEN national Members.

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SIST EN ISO 14534:2002
EN ISO 14534:2002 (E)
CORRECTED  2002-07-31
Foreword
This document (ISO 14534:2002) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 December 2002, and conflicting
national standards shall be withdrawn at the latest by December 2002.
This document supersedes EN ISO 14534:1997.
This document has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s).
For relationship with EU Directive(s), see informative annex ZB, which is an integral part of
this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the
United Kingdom.
Endorsement notice
The text of the International Standard ISO 14534:2002 has been approved by CEN as a
European Standard without any modifications.
NOTE Normative references to International Standards are listed in annex ZA (normative).
2

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SIST EN ISO 14534:2002
EN ISO 14534:2002 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 8320-2 2001 Contact lenses and contact lens EN ISO 8320-2 2001
care products - Vocabulary - Part 2:
Contact lens care products
ISO 8321-1 1991 Optics and optical instruments - EN ISO 8321-1 1996
Contact lenses - Part 1:
Specification for rigid corneal and
scleral contact lenses
ISO 8321-2 2000 Optics and optical instruments - EN ISO 8321-2 2000
Contact lenses - Part 2:
Specifications for single-vision
hydrogel lenses
ISO 10993-1 1997 Biological evaluation of medical EN ISO 10993-1 1997
devices - Part 1: Evaluation and
testing
ISO 11978 2000 Ophthalmic optics - Contact lenses EN ISO 11978 2000
and contact lens care products -
Information to be supplied by the
manufacturer
ISO 11987 1997 Ophthalmic optics - Contact lenses EN ISO 11987 1997
- Methods for the determination of
shelf-life
ISO 13212 1999 Ophthalmic optics - Contact lens EN ISO 13212 1999
care products - Guidelines for the
determination of shelf-life
3

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SIST EN ISO 14534:2002
EN ISO 14534:2002 (E)
ISO 14729 2001 Ophthalmic optics - Contact lens EN ISO 14729 2001
care products - Microbiological
requirements and test methods for
products and regimens for hygienic
management of contact lenses
ISO 14730 2000 Ophthalmic optics - Contact lens EN ISO 14730 2000
care products - Antimicrobial
preservative efficacy testing and
guidance on discard dating of multi-
dose preserved contact lens care
products
4

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SIST EN ISO 14534:2002
EN ISO 14534:2002 (E)
Annex ZB
(informative)
Clauses of this European Standard addressing essential requirements
or other provisions of EU Directives.
This European standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association and supports essential requirements
of EU Directive 93/42/EEC.
WARNING : Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.
The following clauses of this standard, as detailed in table ZB.1, are likely to support
requirements of Directive: 93/42/EEC.
Compliance with the clauses of this standard provides one means of conforming with the
specific essential requirements of the Directive concerned and associated EFTA regulations.
Table ZB.1: Correspondence between this European Standard and EU Directives
Clauses/ Sub-clauses of this Corresponding Comments
European Standard fundamental requirements of
Directive 93/42/EEC
All this standard I.1
4 I.3; I.4; I.5; I.6; II.7.1; II.7.2; II.7.3;
II.7.5; II.7.6; II.9.1; II.10.1
5 I.2; I.6; II.7.2; II.9.2
6 I.2; I.3; I.5; I.6
7 I.2; I.3; I.4; I.5; I.6; II.7.1; II.7.3;
II.8.2
8 I.2; I.4; I.6; II.14
9 I.3; I.5; II.8.5
10 I.3; II.7.2; II.8.3; II.8.4; II.8.5
11 I.3; I.5; II.7.2; II.7.6; II.8.1; II.8.3;
II.8.6
12 I.4; I.5
13 I.5; II.8.7; II.13.1; II.13.2; II.13.3;
II.13.4; II.13.5; II.13.6
5

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SIST EN ISO 14534:2002

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SIST EN ISO 14534:2002


INTERNATIONAL ISO
STANDARD 14534
Second edition
2002-06-15


Ophthalmic optics — Contact lenses and
contact lens care products — Fundamental
requirements
Optique ophtalmique — Lentilles de contact et produits d'entretien des
lentilles de contact — Exigences fondamentales




Reference number
ISO 14534:2002(E)
©
 ISO 2002

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SIST EN ISO 14534:2002
ISO 14534:2002(E)
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ii © ISO 2002 – All rights reserved

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SIST EN ISO 14534:2002
ISO 14534:2002(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Safety and performance.2
5 Risk analysis.2
6 Design.3
7 Materials.3
8 Clinical evaluation.3
9 Manufacturing.3
10 Microbiological requirements.4
11 Packaging.5
12 Shelf-life and discard date.5
13 Labelling and information supplied by the manufacturer.5
Bibliography.7



© ISO 2002 – All rights reserved iii

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SIST EN ISO 14534:2002
ISO 14534:2002(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. 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.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14534 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee
SC 7, Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 14534:1997), which has been technically revised.
iv © ISO 2002 – All rights reserved

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SIST EN ISO 14534:2002
ISO 14534:2002(E)
Introduction
Currently, contact lenses and contact lens care products are regulated in different ways in different countries. This
International Standard was mandated by the Commission of the European Communities to CEN and was originally
developed by a joint ISO/CEN working group to ensure a global input; its first edition was published in 1997. Other
requirements may now be needed in certain countries outside the European Union. It is hoped that the adoption of the
current revision of this International Standard will be yet another step towards the harmonization of standards and mutual
recognition.
© ISO 2002 – All rights reserved v

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SIST EN ISO 14534:2002

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SIST EN ISO 14534:2002
INTERNATIONAL STANDARD ISO 14534:2002(E)

Ophthalmic optics — Contact lenses and contact lens care
products — Fundamental requirements
1 Scope
This International Standard specifies safety and performance requirements for contact lenses, contact lens care
products and other accessories for contact lenses.
This International Standard does not specify electrical safety and electromagnetic compatibility considerations that
might arise from the use of electrical equipment in conjunction with contact lenses and/or contact lens care
products.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
1)
ISO 8320-1:— , Contact lenses and contact lens care products — Vocabulary — Part 1: Contact lenses
ISO 8320-2, Contact lenses and contact lens care products — Vocabulary — Part 2: Contact lens care products
2)
ISO 8321-1:— , Ophthalmic optics — Specifications for material, optical and dimensional properties of contact
lenses — Part 1: Rigid corneal and scleral contact lenses
ISO 8321-2, Ophthalmic optics — Specifications for material, optical and dimensional properties of contact
lenses — Part 2: Single-vision hydrogel contact lenses
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 11978, Ophthalmic optics — Contact lenses and contact lens care products — Information supplied by the
manufacturer
ISO 11987, Ophthalmic optics — Contact lenses — Determination of shelf-life
ISO 13212, Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life
ISO 14729:2001, Ophthalmic optics — Contact lens care products — Microbiological requirements and test
methods for products and regimens for hygienic management of contact lenses

1) To be published. (Revision in parts of ISO 8320:1986)
2) To be published. (Revision of ISO 8321-1:1991)
© ISO 2002 – All rights reserved 1

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SIST EN ISO 14534:2002
ISO 14534:2002(E)
ISO 14730, Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and
guidance on determining discard date
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
3 Terms and definitions
For the purposes of this International Standard, the definitions given in ISO 8320-1 and ISO 8320-2 apply.
4 Safety and performance
4.1 The intended purpose of a contact lens, contact lens care product, or other accessory for contact lenses
shall be documented.
4.2 The performance shall be demonstrated by an evaluation of existing information and history of human use,
together with, if necessary, preclinical and clinical testing. In assessing safety and performance, each of the
following shall be considered and the decisions shall be documented:
a) functional characteristics, intended purpose and conditions of use;
b) specific requirements for rigid contact lenses (see ISO 8321-1) and hydrogel contact lenses (ISO 8321-2);
c) microbiological properties, including bioburden, sterility, contact lens disinfection and preservation activities
(see clause 10);
d) biocompatibility, including extractable substances, cytotoxicity, irritation, sensitization, oral toxicity, sterilization
residues and degradation products (see ISO 10993-1);
e) clinical evaluation (see clause 8);
f) physical and chemical compatibility (including any preservative uptake and release) between contact lenses
and contact lens care products and other accessories for contact lenses;
g) stability, including shelf-life and discard date (see clause 12);
h) other intended purposes, for example, cleaning efficacy or measuring function.
NOTE 1 For test methods, see the normative references and Bibliography.
4.3 In the absence of a relevant International Standard, the manufacturer shall demonstrate that the product is in
accordance with claimed properties, by valid scientific evidence from laboratory and/or clinical studies.
NOTE 2 Manufacturers of contact lenses and contact lens care products are reminded of traceability requirements as
mentioned in International Standards on quality management.
5 Risk analysis
5.1 A formal assessment of risk shall be carried out for each design of contact lens, contact lens care product or
other accessory for contact lenses. Risk analysis shall be carried out using recognized methodology. The result of
the risk analysis shall be documented for all aspects of safety, performance and labelling.
NOTE See for example ISO 14971-1 or EN 1441.
2 © ISO 2002 – All rights reserved

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SIST EN ISO 14534:2002
ISO 14534:2002(E)
5.2 Each risk analysis shall be reviewed:
a) regularly;
b) whenever any changes are made to the product or its method of manufacture;
c) whenever any changes are made to the packaging or labelling; or
d) whenever relevant new information becomes known to the manufacturer.
6 Design
The design shall be documented, validated and verified to demonstrate that the required performance and safety
are achieved when the product is used for its intended purpose.
7 Materials
Materials used for and during the manufacture of contact lenses, contact lens care products and other accessori
...