© ISO 2012 Ophthalmic implants — Intraocular lenses — Part 4 Labelling and information AMENDMENT 1 Implants ophtalmiques — Lentilles intraoculaires — Partie 4 Étiquetage et informations AMENDEMENT 1 I[.]
INTERNATIONAL STANDARD ISO 11979-4 Second edition 2008-12-01 AMENDMENT 2012-10-01 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information AMENDMENT Implants ophtalmiques — Lentilles intraoculaires — Partie 4: Étiquetage et informations AMENDEMENT Reference number ISO 11979-4:2008/Amd.1:2012(E) `,`,,,,,```,````,`,,`,`````-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS © ISO 2012 Licensee=University of Alberta/5966844001, User=sharabiani, shahramfs Not for Resale, 12/03/2013 08:43:56 MST `,`,,,,,```,````,`,,`,`````-`-`,,`,,`,`,,` - ISO 11979-4:2008/Amd.1:2012(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2012 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 Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS © ISO 2012 – All rights reserved Licensee=University of Alberta/5966844001, User=sharabiani, shahramfs Not for Resale, 12/03/2013 08:43:56 MST ISO 11979-4:2008/Amd.1:2012(E) 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 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 Amendment to ISO 11979-4:2008 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments `,`,,,,,```,````,`,,`,`````-`-`,,`,,`,`,,` - iii © ISO 2012 – All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sharabiani, shahramfs Not for Resale, 12/03/2013 08:43:56 MST `,`,,,,,```,````,`,,`,`````-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sharabiani, shahramfs Not for Resale, 12/03/2013 08:43:56 MST ISO 11979-4:2008/Amd.1:2012(E) Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information AMENDMENT Page 1, Normative references Delete the following: ISO 11979-9:2006, Ophthalmic implants ― Intraocular lenses ― Part 9: Multifocal intraocular lenses Page 3, Clause Item 21 Information For toric intraocular lenses only: Primary package and/or wrapping(s) Storage container x x the spherical equivalent power (SE) and the absolute cylinder power (CYL) 22 For toric intraocular lenses only: Comments Additionally sphere, cylinder and axis (in + or − cylinder notation) may be given x `,`,,,,,```,````,`,,`,`````-`-`,,`,,`,`,,` - In Table 2, add table rows to provide the new items 21 and 22: the orientation of the meridian of lowest positive power or most negative power depicted in the lens drawing (see item 13) Page 3, Clause Delete list item n) In consequence, renumber list item o) as list item n) and list item p) as list item o) Page Add the following clause: Additional information Where UV blocking is stated, it shall be accompanied by the 10 % cut-off wavelength in nanometres © ISO 2012 – All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sharabiani, shahramfs Not for Resale, 12/03/2013 08:43:56 MST ISO 11979-4:2008/Amd.1:2012(E) `,`,,,,,```,````,`,,`,`````-`-`,,`,,`,`,,` - ICS 11.040.70 Price based on page © ISO 2012 – All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sharabiani, shahramfs Not for Resale, 12/03/2013 08:43:56 MST