SIST EN ISO 14534:2009

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



SIST EN ISO 14534:2009



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



EN ISO 14534:2009 (E) 2 Contents Page Foreword .3 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4
SIST EN ISO 14534:2009



EN ISO 14534:2009 (E) 3 Foreword The text of ISO 14534:2002 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14534:2009 by 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 September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. 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 14534:2002. 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 93/42/EEC, as amended by Directive 2007/47/EC. For relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, 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, 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 14534:2002 has been approved by CEN as a EN ISO 14534:2009 without any modification. SIST EN ISO 14534:2009



EN ISO 14534:2009 (E) 4 Annex ZA (informative)
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
SIST EN ISO 14534:2009



ISO 14534:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO 14534:2009



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
SIST EN ISO 14534:2009



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



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, Contact lenses and contact lens care products — Vocabulary — Part 2: Contact lens care products ISO 8321-1:—2), 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) SIST EN ISO 14534:2009



ISO 14534:2002(E) 2 © ISO 2002 – All rights reserved
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. SIST EN ISO 14534:2009



ISO 14534:2002(E) © ISO 2002 – All rights reserved 3 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 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. The reasons for choosing the selected materials shall be documented. 8 Clinical evaluation The safety and/or 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 e
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