EN ISO 14534:2009
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
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.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2002)
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 und/oder Kontaktlinsenpflegemitteln ergeben können.
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Exigences fondamentales (ISO 14534:2002)
Basic template for the development of ISO and ISO/IEC standards
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Temeljne zahteve (ISO 14534:2002)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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)Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 14534:2009SIST EN ISO 14534:2009en01-maj-2009SIST EN ISO 14534:2009SLOVENSKI
STANDARDSIST EN ISO 14534:20021DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14534March 2009ICS 11.040.70Supersedes EN ISO 14534:2002
English VersionOphthalmic optics - Contact lenses and contact lens careproducts - Fundamental requirements (ISO 14534:2002)Optique ophtalmique - Lentilles de contact et produitsd'entretien des lentilles de contact - Exigencesfondamentales (ISO 14534:2002)Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel -Grundlegende Anforderungen (ISO 14534:2002)This European Standard was approved by CEN on 7 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14534:2009: ESIST EN ISO 14534:2009
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European 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 Communities 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 European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s)
of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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; I.6 a) Clause 8 of this standard makes reference to two horizontal standards on clinical investigation, ISO 14155 and EN 540.
Note that EN 540 has been withdrawn since and a revised edition of ISO 14155 has become available and published in two parts.
The correct European Standards to use instead of these two are EN ISO 14155-1 and EN ISO 14155-2. 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 ER 13.3 a) is only partly addressed in EN ISO 14534 (with regard to the identification of authorized representative).
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 14534:2009
Reference numberISO 14534:2002(E)© ISO 2002
INTERNATIONAL STANDARD ISO14534Second edition2002-06-15Ophthalmic 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
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ii © ISO 2002 – All rights reserved
ISO 14534:2002(E) © ISO 2002 – All rights reserved iii 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 14534:2002(E) iv © ISO 2002 – All rights reserved
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. SIST EN ISO 14534:2009
ISO 14534:2002(E) © ISO 2002 – All rights reserved v 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. SIST EN ISO 14534:2009
INTERNATIONAL STANDARD ISO 14534:2002(E) © ISO 2002 – All rights reserved 1 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. ISO 8320-1:—1), Contact lenses and contact lens care products — Vocabulary — Part 1: Contact lenses ISO 8320-2, Contac
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