EN ISO 14889:2009

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

ISO 14889:2002 specifies fundamental requirements for uncut finished spectacle lenses. This International Standard is not applicable to protective spectacle lenses.
ISO 14889:2002 takes precedence over the corresponding requirements of other standards, if differences exist.

Augenoptik - Brillengläser - Grundlegende Anforderungen an rohkantige fertige Brillengläser (ISO 14889:2003)

Optique ophtalmique - Verres de lunettes - Exigences fondamentales relatives aux verres finis non détourés (ISO 14889:2003)

L'ISO 14889:2002 spécifie les exigences fondamentales pour les verres de lunettes finis non détourés. Cette norme internationale ne s'applique pas aux verres de lunettes de protection.
L'ISO 14889:2002 a la priorité sur les exigences correspondantes dans les autres normes, lorsqu'il existe des différences.

Očesna optika - Stekla očal - Temeljne zahteve za nebrušena gotova stekla (ISO 14889:2003)

General Information

• Status: Withdrawn
• Publication Date: 24-Mar-2009
• Withdrawal Date: 01-Oct-2013
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 02-Oct-2013
• Completion Date: 02-Oct-2013
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14889:2009 - Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

Relations

• Replaces: EN ISO 14889:2003 - Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 14889:2013 - Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2013)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Brillengläser - Grundlegende Anforderungen an rohkantige fertige Brillengläser (ISO 14889:2003)Optique ophtalmique - Verres de lunettes - Exigences fondamentales relatives aux verres finis non détourés (ISO 14889:2003)Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 14889:2009SIST EN ISO 14889:2009en01-maj-2009SIST EN ISO 14889:2009SLOVENSKI
STANDARDSIST EN ISO 14889:20031DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14889March 2009ICS 11.040.70Supersedes EN ISO 14889:2003
English VersionOphthalmic optics - Spectacle lenses - Fundamentalrequirements for uncut finished lenses (ISO 14889:2003)Optique ophtalmique - Verres de lunettes - Exigencesfondamentales relatives aux verres finis non détourés (ISO14889:2003)Augenoptik - Brillengläser - Grundlegende Anforderungenan rohkantige fertige Brillengläser (ISO 14889:2003)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 14889:2009: ESIST EN ISO 14889:2009

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 4, 5 I.1, I.3
4.2, 4.3.1 I.2, I.6, I.6 a) New ER I.6 a) is implicitly covered by subclause 4.3.1 of EN ISO 14889. Manufacturers will have to take new ER I.6.a) into consideration when preparing their declaration of conformity. 4.3.1, 4.3.2, 4.4, 5.2, 5.3 II.7.1
4.4, 5.3 II.9.2
4.3.2, 5.2 II.9.3
6 II.13.1, II.13.3 The relevant Essential Requirement of II.13.3 a) is only partly addressed in subclause 6.1 e) of EN ISO 14889.
(according to article 1 (6) of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 89/686/EEC Qualifying remarks/Notes --- --- General A manufacturer may claim that his lenses in addi-tion of being corrective lenses be protective lenses that provide personal eye protection to the user. As a matter of fact, personal eye protection can relate to various kinds of risk, e.g. sunglare (indirect solar radiation1), radiation other than indirect solar radiation, mechanical impact, etc.
Some of those risks call for requirements that go beyond those for lenses the primary function of which is correction of vision. For the purposes of EN ISO 14889, the following applies. --- --- Corrective lenses with filter properties against sunglare (indirect solar radiation) In accordance with the European Commission's "GUIDELINES ON THE APPLICATION OF COUNCIL DIRECTIVE 89/686/EEC OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT" such lenses are categorized as medical devices, thus falling under Directive 93/42/EEC. Compliance with the ERs of Directive 93/42/EEC, and of EN ISO 14889 as detailed by the above Table ZA.1 implies that the relevant requirements are met. --- --- Corrective lenses designed to provide protection other than protection against sunglare (indirect solar radiation) Where corrective lenses are designed to provide protection other than protection against sunglare (indirect solar radiation), the relevant basic health and safety requirements of Directive 89/ 686/EEC apply.
These are not addressed in EN ISO 14889. Refer to Directive 89/686/EEC and the relevant European Standard(s) on personal eye protection. WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
1 Indirect solar radiation implies general use for protection against solar radiation but not for direct observation of the sun. SIST EN ISO 14889:2009

Reference numberISO 14889:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO14889Second edition2003-05-15Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses Optique ophtalmique — Verres de lunettes — Exigences fondamentales relatives aux verres finis non détourés
ISO 14889:2003(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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ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2003 — All rights reserved
ISO 14889:2003(E) © ISO 2003 — All rights reserved iii 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 14889 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 14889:1997), which has been technically revised. SIST EN ISO 14889:2009

INTERNATIONAL STANDARD ISO 14889:2003(E) © ISO 2003 — All rights reserved 1 Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses 1 Scope This International Standard specifies fundamental requirements for uncut finished spectacle lenses. This International Standard is not applicable to protective spectacle lenses. This International Standard takes precedence over the corresponding requirements of other standards, if differences exist. 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 8980-1, Ophthalmic optics — Uncut finished spectacle lenses — Part 1: Specifications for single-vision and multifocal lenses ISO 8980-2, Ophthalmic optics — Uncut finished spectacle lenses — Part 2: Specifications for progressive power lenses ISO 8980-3, Ophthalmic optics — Uncut finished spectacle lenses — Part 3: Transmittance specifications and test methods ISO 8980-4, Ophthalmic optics — Uncut finished spectacle lenses — Part 4: Specifications and test methods for anti-reflective coatings ISO 13666, Ophthalmic optics — Spectacle lenses — Vocabulary 3 Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 13666 as well as the following. 3.1 manufacturer (of an uncut finished spectacle lens) natural or legal person who places the uncut finished lens on the market SIST EN ISO 14889:2009

ISO 14889:2003(E) 2 © ISO 2003 — All rights reserved 4 Fundamental requirements for spectacle lenses 4.1 Performance In addition to the requirements specified in this International Standard, uncut finished lenses shall comply with the relevant parts of ISO 8980. 4.2 Design Spectacle lenses shall be designed so that the overall risk associated with their use according to the conditions intended by the manufacturer, relative to the risk when the spectacle lenses are not used, is reduced to a level consistent with the materials used and compatible with the generally acknowledged state-of-the-art. 4.3 Materials 4.3.1 Physiological compatibility Lenses shall not be made from materials known to be physiologically incompatible or known to create allergic or toxic reactions amongst a significant proportion of wearers when the lenses are used as intended by the manufacturer. 4.3.2 Inflammability When the lens is tested as described in 5.2, there shall be no continued combustion after withdrawal of the test rod.
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