SIST EN ISO 14534:2011
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
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 or contact lens care products.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011)
Diese Internationale Norm legt Anforderungen an die Sicherheit und Funktion von Kontaktlinsen, Kontaktlinsenpflegemitteln
und anderem Zubehör für Kontaktlinsen fest.
Diese Internationale Norm legt keine Anforderungen zur elektrischen Sicherheit und zur elektromagnetischen
Verträglichkeit fest, die sich möglicherweise durch den Gebrauch von elektrischen Geräten in Verbindung mit
Kontaktlinsen oder Kontaktlinsenpflegemitteln ergeben können.
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2011)
L'ISO 14534:2011 spécifie les exigences de sécurité et de performance s'appliquant aux lentilles de contact, produits d'entretien des lentilles de contact et autres accessoires utilisés avec les lentilles de contact.
L'ISO 14534:2011 ne traite pas de sécurité électrique ni de considérations de compatibilité électromagnétique potentiellement liées à l'utilisation d'équipements électriques avec les lentilles de contact et/ou les produits d'entretien pour lentilles de contact.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Temeljne zahteve (ISO 14534:2011)
Ta mednarodni standard določa varnostne in delovne zahteve za kontaktne leče, izdelke za vzdrževanje kontaktnih leč in drugih pripomočkov za kontaktne leče. Ta mednarodni standard ne določa električne varnosti in vidike elektromagnetne združljivosti, ki se lahko pojavijo z uporabo električne opreme skupaj s kontaktnimi lečami ali izdelki za vzdrževanje kontaktnih leč.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14534:2011
01-julij-2011
1DGRPHãþD
SIST EN ISO 14534:2009
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHNRQWDNWQLKOHþ7HPHOMQH
]DKWHYH ,62
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental
requirements (ISO 14534:2011)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen
(ISO 14534:2011)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Exigences fondamentales (ISO 14534:2011)
Ta slovenski standard je istoveten z: EN ISO 14534:2011
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 14534:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14534:2011
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SIST EN ISO 14534:2011
EUROPEAN STANDARD
EN ISO 14534
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.040.70 Supersedes EN ISO 14534:2009
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Fundamental requirements (ISO 14534:2011)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -
d'entretien des lentilles de contact - Exigences Grundlegende Anforderungen (ISO 14534:2011)
fondamentales (ISO 14534:2011)
This European Standard was approved by CEN on 31 March 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14534:2011: E
worldwide for CEN national Members.
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SIST EN ISO 14534:2011
EN ISO 14534:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EC Directive 93/42/EEC .4
2
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SIST EN ISO 14534:2011
EN ISO 14534:2011 (E)
Foreword
This document (EN ISO 14534:2011) 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 October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14534:2009.
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 ZA, 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, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14534:2011 has been approved by CEN as a EN ISO 14534:2011 without any modification.
3
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SIST EN ISO 14534:2011
EN ISO 14534:2011 (E)
Annex ZA
(informative)
Relationship between this International Standard and the
Essential Requirements of EC Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this International Standard of Directive 93/42/EEC
All this standard. 1
4 3, 4, 5, 6, 6a), 7.1, 7.2, 7.3, 7.5, 7.6,
8.1, 9.1, 10.1
5 2, 6, 7.2, 9.2
6 2, 3, 5, 6
7 2, 3, 4, 5, 6, 7.1, 7.3, 8.2
8 2, 3, 4, 6, 6a) Clause 8 of this International Standard
makes normative reference to a
horizontal standard on clinical
investigation, ISO 14155.
9 3, 5, 8.4, 8.5
10 3, 7.2, 8.1, 8.3, 8.4, 8.5
11 3, 5, 7.2, 7.6, 8.1, 8.3, 8.6, 8.7
12 4, 5
13 5, 8.7, 9.1, 13.1, 13.2, 13.3, 13.4, 13.5, Labelling is partly addressed by
13.6 normative reference to ISO 11978.
Note that ISO 11978:2000: only partly
addresses ER 13.3a) (there is no
reference to the authorized
representative) and ER 13.3 f); and
does not address ER 13.6 q) and that
part of ER 13.6 h) that relates to single
use.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
4
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SIST EN ISO 14534:2011
INTERNATIONAL ISO
STANDARD 14534
Third edition
2011-04-01
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 14534:2011(E)
©
ISO 2011
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SIST EN ISO 14534:2011
ISO 14534:2011(E)
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ii © ISO 2011 – All rights reserved
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SIST EN ISO 14534:2011
ISO 14534:2011(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 2.
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 document 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 photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 14534:2002), which has been technically
revised.
© ISO 2011 – All rights reserved iii
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SIST EN ISO 14534:2011
ISO 14534:2011(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
ISO 14534:1997. It is possible that other requirements are now needed in certain countries outside the
European Union. It is hoped that the adoption of the third edition of this International Standard will be yet
another step towards the harmonization of standards and mutual recognition.
iv © ISO 2011 – All rights reserved
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SIST EN ISO 14534:2011
INTERNATIONAL STANDARD ISO 14534:2011(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 or contact lens care
products.
2 Normative references
The following referenced documents are indispensable for the application 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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11978, Ophthalmic optics — Contact lenses and contact lens care products — Information supplied by
the manufacturer
ISO 11980, Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical
investigations
ISO 11986, Ophthalmic optics — Contact lenses and contact lens care products — Determination of
preservative uptake and release
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 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14729:2001 + Amd.1:2010, Ophthalmic optics — Contact lens care products — Microbiological
requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14730, Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and
guidance on determining discard date
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
© ISO 2011 – All rights reserved 1
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SIST EN ISO 14534:2011
ISO 14534:2011(E)
ISO 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
ISO 18369-2, Ophthalmic optics — Contact lenses — Part 2: Tolerances
ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 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 and hydrogel contact lenses as specified in ISO 18369-2;
c) microbiological properties, including bioburden, sterility, contact lens disinfection, and preservation
activities (see Clause 10);
d) biocompatibility, including extractable substances, cytotoxicity, irritation, sensitization, sterilization
residues, and degradation products — the relevant requirements of ISO 10993-1 shall apply;
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 as specified in
ISO 11986;
g) stability, including shelf-life and discard date (see Clause 12);
h) other intended purposes, e.g. cleaning efficacy or measuring function.
NOTE For test methods, see the references in Clause 2 and the 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 or clinical studies.
NOTE Manufacturers of contact lenses and contact lens care products are reminded of traceability requirements as
mentioned in International Standards on quality management.
5 Risk assessment
5.1 A formal risk assessment shall be carried out for each design of contact lens, contact lens care product
or other accessory for contact lenses. Risk assessment shall be carried out using recognized methodology.
The result of the risk assessment shall be documented for all aspects of safety, performance and labelling.
ISO 14971 shall apply.
2 © ISO 2011 – All rights reserved
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SIST EN ISO 14534:2011
ISO 14534:2011(E)
5.2 Each risk assessment 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;
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
7.1 Materials used for and during the manufacture of contact lenses, contact lens care products, and other
accessories for contact lenses shall be chosen with regard to the properties necessary to meet the
requirements for safety, performance, manufacture, handling, and compatibility with other materials with which
they may come into contact.
7.2 For materials of animal origin, ISO 22442 (all parts) shall apply.
7.3 The reasons for choosing the selected materials shall be documented.
8 Clinical evaluation
The safety and performance of a product for its intended purpose shall be clinically evaluated by one or more
of the following methods:
a) compilation of relevant scientific literature currently available on the intended purpose and performance of
the device and the evaluation techniques employed;
b) experience during previous use;
c) clinical investigation.
Any clinical investigation shall comply with principles of good clinical practice such as laid down in ISO 14155
and ISO 11980.
9 Manufacturing
Manufacturing processes shall be documented and controlled to ensure that the defined product quality is
achieved. The product shall fulfil the quality requirements defined in the design documents or product
specifications. These defined levels of chemical, physical or biological parameters shall be met, especially
those concerning particulate and microbiological contaminants which could adversely affect practitioner or
user safety and also
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