ISO-11978-2000.pdf
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1、Reference number ISO 11978:2000(E) ISO 2000 INTERNATIONAL STANDARD ISO 11978 First edition 2000-03-15 Ophthalmic optics Contact lenses and contact lens care products Information supplied by the manufacturer Optique ophtalmique Lentilles de contact et produits dentretien des lentilles de contact Info
2、rmations fournir par le fabricant Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 09:12:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11978:200
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6、SO 2000 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 ISOs member body in th
7、e country of the requester. ISO copyright office Case postale 56 ? CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 734 10 79 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2000 All rights reserved Copyright International Organization for Standardization Provided by IHS unde
8、r license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 09:12:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11978:2000(E) ISO 2000 All rights reservediii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3T
9、erms and definitions .1 4Contact lens information supplied by the manufacturer.2 4.1General2 4.2Label2 4.3Instructions for use .3 5Contact lens care product information supplied by the manufacturer4 5.1General4 5.2Label4 5.3Instructions for use .6 Bibliography7 Copyright International Organization f
10、or Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 09:12:08 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11978:2000(E) iv ISO 2000 All rights reserved Foreword ISO (the International Org
11、anization 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 establi
12、shed 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 standardizatio
13、n. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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 % o
14、f 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. International Standard ISO 11978 was prepared by Te
15、chnical Committee ISO/TC 172,Optics and optical instruments, Subcommittee SC 7,Ophthalmic optics and instruments. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 09:12:08 MDTNo r
16、eproduction or networking permitted without license from IHS -,-,- ISO 11978:2000(E) ISO 2000 All rights reservedv Introduction This International Standard attempts to harmonize requirements, whenever possible, for labelling of contact lenses and contact lens care products with national laws, regula
17、tions or guidelines that may exist in countries throughout the world. Where national laws and labelling requirements exist in countries for medical devices, they are often developed by legislative bodies or regulatory authorities independently from the development process for International Standards
18、. Therefore, labelling requirements established by an individual country cannot always be readily integrated into International Standards. The information given in this International Standard provides a suitable framework for developing labelling for contact lenses and contact lens care products. Co
19、nformance to the elements herein should be sufficient for developing appropriate labelling for countries without existing laws or regulations for medical device labelling. However, conformance with the elements of this International Standard may not be sufficient for full compliance with additional
20、labelling requirements mandated by an individual country. Where national laws or regulations mandate additional labelling requirements or conflict with elements of this International Standard, the national law or regulation should be followed and should take precedence over the elements of this volu
21、ntary International Standard. Manufacturers should familiarize themselves with the labelling requirements, if any, of the countries chosen for marketing of their products. Failure to comply with labelling requirements of a specific country could result in serious consequences for a manufacturer that
22、 could otherwise have been avoided. Conformance with the elements of this International Standard should minimize, but may not necessarily eliminate, the risks for developing labelling that could seriously violate or conflict with specific requirements mandated by the laws and regulations of an indiv
23、idual country. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 09:12:08 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organiza
24、tion for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/22/2007 09:12:08 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 11978:2000(E) ISO 2000 All rights reserved1 Ophthalmi
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