SIST EN ISO 14889:2009
(Main)Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
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.
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)
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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
SIST EN ISO 14889:2009
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
EN ISO 14889:2009 (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 14889:2009
EN ISO 14889:2009 (E) 3 Foreword The text of ISO 14889:2003 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 14889:2009 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 14889:2003. 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 14889:2003 has been approved by CEN as a EN ISO 14889:2009 without any modification. SIST EN ISO 14889:2009
EN ISO 14889:2009 (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 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.
SIST EN ISO 14889:2009
EN ISO 14889:2009 (E) 5 For devices intended by the manufacturer to be for dual use in accordance with Article 1(6) of Directive 93/42 EEC the following Table ZA.2 details the relevant essential requirements of Directive 89/686/EC on Personal Protective Equipment and their corresponding clauses of this European Standard. Table ZA.2 however, does not imply any citation in the OJEU under the PPE directive and thus does not provide presumption of conformity for the PPE directive. Table ZA.2 – Relevant Essential Requirements from Directive 89/686/EEC on Personal Protective Equipment that are addressed by this European Standard
(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
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
SIST EN ISO 14889:2009
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SIST EN ISO 14889:2009
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 lea
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