SIST EN ISO 11979-4:2009
(Main)Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO 11979-4:2008)
Dieser Teil von ISO 11979 legt Anforderungen an die Etikettierung von Intraokularlinsen (IOLs) und die in oder auf deren Verpackung anzugebenden Informationen fest.
ANMERKUNG Dieser Teil von ISO 11979 versucht, die weltweit bestehenden Anforderungen an die Etikettierung von Intraokularlinsen zu harmonisieren. Nationale Anforderungen können jedoch zusätzliche Regelungen beinhalten.
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations (ISO 11979-4:2008)
L'ISO 11979-4:2008 spécifie les exigences relatives à l'étiquetage des lentilles intraoculaires (LIO), ainsi que les informations à fournir dans leur emballage ou sur celui-ci.
Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije (ISO 11979-4:2008)
Ta del standarda ISO 11979 določa zahteve za označevanje intraokularnih leč (IOL) in informacije, ki morajo biti priložene embalaži ali biti natisnjene na embalaži.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO 11979-4:2008)Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations (ISO 11979-4:2008)Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 11979-4:2008SIST EN ISO 11979-4:2009en01-marec-2009SIST EN ISO 11979-4:2009SLOVENSKI
STANDARDSIST EN ISO 11979-4:20001DGRPHãþD
SIST EN ISO 11979-4:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 11979-4December 2008ICS 11.040.70Supersedes EN ISO 11979-4:2000
English VersionOphthalmic implants - Intraocular lenses - Part 4: Labelling andinformation (ISO 11979-4:2008)Implants ophtalmiques - Lentilles intraoculaires - Partie 4:Étiquetage et informations (ISO 11979-4:2008)Ophthalmische Implantate - Intraokularlinsen - Teil 4:Etikettierung und Information (ISO 11979-4:2008)This European Standard was approved by CEN on 29 November 2008.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: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11979-4:2008: ESIST EN ISO 11979-4:2009
EN ISO 11979-4:2008 (E) 2 Contents Page Foreword .3 SIST EN ISO 11979-4:2009
EN ISO 11979-4:2008 (E) 3 Foreword This document (EN ISO 11979-4:2008) has been prepared by Technical Committee ISO/TC 172 "Optics and optical instruments" in collaboration with 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 June 2009, and conflicting national standards shall be withdrawn at the latest by June 2009. 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 11979-4:2000. 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 11979-4:2008 has been approved by CEN as a EN ISO 11979-4:2008 without any modification.
SIST EN ISO 11979-4:2009
SIST EN ISO 11979-4:2009
Reference numberISO 11979-4:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO11979-4Second edition2008-12-01Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information Implants ophtalmiques — Lentilles intraoculaires — Partie 4: Étiquetage et informations
SIST EN ISO 11979-4:2009
ISO 11979-4:2008(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.
COPYRIGHT PROTECTED DOCUMENT
©
ISO 2008 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.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland
ii © ISO 2008 – All rights reserved
SIST EN ISO 11979-4:2009
ISO 11979-4:2008(E) © ISO 2008 – All rights reserved iiiForeword 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 11979-4 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 11979-4:2000), which has been technically revised. ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular lenses: ⎯ Part 1: Vocabulary ⎯ Part 2: Optical properties and test methods ⎯ Part 3: Mechanical properties and test methods ⎯ Part 4: Labelling and information ⎯ Part 5: Biocompatibility ⎯ Part 6: Shelf-life and transport stability ⎯ Part 7: Clinical investigations ⎯ Part 8: Fundamental requirements ⎯ Part 9: Multifocal intraocular lenses ⎯ Part 10: Phakic intraocular lenses SIST EN ISO 11979-4:2009
ISO 11979-4:2008(E) iv © ISO 2008 – All rights reserved Introduction This part of ISO 11979 contains requirements and guidance for the labelling of intraocular lens
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.