BS-EN-ISO-11979-9-2006.pdf
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1、BRITISH STANDARD BS EN ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses The European Standard EN ISO 11979-9:2006 has the status of a British Standard ICS 11.040.70 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 2006, Uncontro
2、lled Copy, (c) BSI BS EN ISO 11979-9:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006 ISBN 0 580 49056 4 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 11979-9:
3、2006. The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/7, Eye implants. A list of organizations represented on CH/172/7 can be obtained on request to its secretary. This publication does not purport to include all the nece
4、ssary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 200
5、6, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-9 September 2006 ICS 11.040.70 English Version Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006) Implants ophtalmiques - Lentilles intraoculaires - Partie 9:
6、 Lentilles intraoculaires multifocales (ISO 11979-9:2006) Ophthalmische Implantate - Intraokularlinsen - Teil 9: Multifokale Intraokularlinsen (ISO 11979-9:2006) This European Standard was approved by CEN on 19 August 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations wh
7、ich 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 Central Secretariat or to any CEN member. This European St
8、andard 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 Central Secretariat has the same status as the official versions. CEN members are the national st
9、andards bodies of Austria, Belgium, 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. E
10、UROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-9:2006: E Lice
11、nsed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 11979-9:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic op
12、tics“, 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 March 2007, and conflicting national standards shall be withdrawn at the latest by March 2007. Accor
13、ding to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuan
14、ia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11979-9:2006 has been approved by CEN as EN ISO 11979-9:2006 without any modifications. EN ISO 11979-9:2006 Licensed Copy: shef
15、fieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11979-9:2006(E) INTERNATIONAL STANDARD ISO 11979-9 First edition 2006-09-01 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses Implants ophtalmiques Lentilles intrao
16、culaires Partie 9: Lentilles intraoculaires multifocales EN ISO 11979-9:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Co
17、ntents Page Foreword iv 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Physical requirements 2 4.1 General. 2 4.2 Tolerances and dimensions 2 5 Optical requirements 2 5.1 General. 2 5.2 Dioptric power. 2 5.3 Imaging quality 2 5.4 Additional optical characterization. 3 6 Clinical
18、investigation 3 6.1 General. 3 6.2 Additional requirements for the clinical investigation plan. 4 7 Information supplied by the manufacturer 4 Annex A (normative) Optical characterization 6 Annex B (informative) Clinical investigation. 8 Annex C (informative) Determination of sample sizes for the cl
19、inical investigation 16 Bibliography. 20 EN ISO 11979-9:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 15:06:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member
20、 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
21、 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 Directiv
22、es, 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
23、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 11979-9 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Sub
24、committee SC 7, Ophthalmic optics and instruments. 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 informatio
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