SIST EN 14139:2010

Ophthalmic optics - Specifications for ready-to-wear spectacles

This European Standard specifies the minimum requirements for complete ready-to-wear spectacles. These are not intended for regular use without the approval of an eye-care professional.

Augenoptik - Anforderungen an Fertigbrillen

Diese Europäische Norm legt Mindestanforderungen an Fertigbrillen fest. Fertigbrillen sind ohne Zustimmung eines Angehörigen augenoptischer Fachkreise (Augenärzte, Augenoptiker) nicht für den regelmäßigen Gebrauch vorgesehen.

Optique ophtalmique - Spécifications pour les lunettes prémontées

La présente Norme européenne spécifie les exigences minimales requises pour les lunettes prémontées. Ces dernières ne sont pas destinées à être utilisées de manière régulière sans l’avis d’un professionnel de la vue (praticien).

Očesna optika - Specifikacije za že narejena očala

Ta evropski standard določa minimalne zahteve za že narejena očala. Ta brez odobritve očesnega strokovnjaka niso namenjena za redno uporabo.

General Information

• Status: Published
• Public Enquiry End Date: 14-Feb-2010
• Publication Date: 14-Sep-2010
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 20-Aug-2010
• Due Date: 25-Oct-2010
• Completion Date: 15-Sep-2010
• 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: EN 14139:2010 - Ophthalmic optics - Specifications for ready-to-wear spectacles

Relations

• Replaces: SIST EN 14139:2003 - Ophthalmic optics - Specifications for ready-to-wear spectacles
• Effective Date: 01-Oct-2010
• Replaces: SIST EN 14139:2003/AC:2006 - Ophthalmic optics - Specifications for ready-to-wear spectacles
• Effective Date: 01-Oct-2010

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Anforderungen an FertigbrillenOptique ophtalmique - Spécifications pour les lunettes prémontéesOphthalmic optics - Specifications for ready-to-wear spectacles11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN 14139:2010SIST EN 14139:2010en,fr,de01-oktober-2010SIST EN 14139:2010SLOVENSKI
STANDARDSIST EN 14139:2003/AC:2006SIST EN 14139:20031DGRPHãþD



SIST EN 14139:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14139
June 2010 ICS 11.040.70 Supersedes EN 14139:2002English Version
Ophthalmic optics - Specifications for ready-to-wear spectacles Optique ophtalmique - Spécifications pour les lunettes prémontées
Augenoptik - Anforderungen an Fertigbrillen This European Standard was approved by CEN on 13 May 2010.
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 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 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 © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14139:2010: ESIST EN 14139:2010



EN 14139:2010 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Terms and definitions .44Performance requirements .44.1General .44.2General requirements .44.3Optical power range .54.4Optical power tolerances .54.5Reference points and prismatic power tolerances .54.5.1Design reference points .54.5.2Prismatic power tolerances .55Marking on the spectacles, indications on packaging, instruction for use .55.1Marking .55.2Indications on packaging and warnings .5Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .7 SIST EN 14139:2010



EN 14139:2010 (E) 3 Foreword This document (EN 14139:2010) has been prepared 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 December 2010, and conflicting national standards shall be withdrawn at the latest by December 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 14139:2002. It has been adapted from ISO 16034:2002. 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. Significant technical changes from the previous edition of the document: - clarification that the marking of ready-to-wear spectacles according to EN ISO 12870 is optional (note to subclause 5.1). - amendment of requirements regarding the information to be provided by the manufacturer (subclause 5.2). - the new edition of the standard is placed under EC Mandate (Directive 93/42/EEC on medical devices ) and an Annex ZA was hence added. 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. SIST EN 14139:2010



EN 14139:2010 (E) 4
1
Scope This European Standard specifies the minimum requirements for complete ready-to-wear spectacles. These are not intended for regular use without the approval of an eye-care professional. 2 Normative references The following referenced documents
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