EN ISO 11979-9-2006 en Ophthalmic implants - Intraocular lenses - Part 9 Multifocal intraocular lenses (Incorporates Amendment A1 2014)《眼科植入物 眼内透镜 第9部分 多点聚焦眼内透镜 ISO 117979-9-2006》.pdf

1、BRITISH STANDARDBS EN ISO 11979-9:2006Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lensesThe European StandardEN ISO 11979-9:2006 has the status of a British StandardICS 11.040.70 BS EN ISO +A1:2014BS EN ISO 11979-9:2006+A1:2014ISBN 978 0 580 82537 8Amendments/corrigenda iss

2、ued since publicationDate Comments30 September 2014 Implementation of ISO amendment 1:2014 with CEN endorsement A1:2014This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 The British Standards Institution 2014. Published by BSI St

3、andards Limited 2014National forewordThis British Standard is the UK implementation of EN ISO 11979-9:2006+A1:2014. It is identical to ISO 11979-9:2009, incorporating amendment 1:2014. It supersedes BS EN ISO 11979-9:2006, which is withdrawn.The start and finish of text introduced or altered by amen

4、dment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/

5、172/7, Eye implants.A list of organizations represented on this subcommittee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot

6、 confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11979-9September 2006ICS 11.040.70English VersionOphthalmic implants - Intraocular lenses - Part 9: Multifocalintraocular lenses (ISO 11979-9:2006)Implants ophtalmiques - Lentilles intraoculaires - Partie 9

7、: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 which

8、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 Central Secretariat or to any CEN member.This European Standard

9、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 Central Secretariat has the same status as the officialversions.CEN members are the national standards bo

10、dies 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.EUROPEAN COMMI

11、TTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11979-9:2006: EEN ISO 11979-9:2006+A1

12、August 2014Foreword 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 optics“, the secretariat of which is held by DIN.This European Standard shall be given the statu

13、s of a national standard, either by publication ofan identical textor by endorsement, at the latestbyMarch 2007, and conflicting nationalstandards shall bewithdrawn at the latest by March 2007. According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following co

14、untries are bound to implement this European Standard: 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

15、, Switzerland and United Kingdom. Endorsement notice The text of ISO 11979-9:2006 has been approved byCEN as EN ISO 11979-9:2006 without anymodifications. EN ISO 11979-9:2006BS EN ISO 11979-9:2006+A1:2014EN ISO 11979-9:2006+A1:2014EN ISO 11979-9:2006/A1:2014 (E) 3 Foreword This document (EN ISO 1197

16、9-9:2006/A1:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 11979-9:2006 shall be given the status of a na

17、tional standard, either by publication of an identical text or by endorsement, at the latest by February 2015, and conflicting national standards shall be withdrawn at the latest by February 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of

18、patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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,

19、 Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey

20、and the United Kingdom. Endorsement notice The text of ISO 11979-9:2006/Amd, 1:2014 has been approved by CEN as EN ISO 11979-9:2006/A1:2014 without any modification. Foreword to amendment A1Reference numberISO 11979-9:2006(E)INTERNATIONAL STANDARDISO11979-9First edition2006-09-01Ophthalmic implants

21、In traocular lenses Part 9: Multifocal intraocular lenses Implants ophtalmiques Lentilles intraoculaires Partie 9: Lentilles intraoculaires multifocalesEN ISO 11979-9:2006BS EN ISO 11979-9:2006+A1:2014EN ISO 11979-9:2006+A1:2014ii iiiContents PageForeword iv1Scope . 12Normative references. 13Terms a

22、nd definitions. 14Physical requirements 24.1 General. 24.2 Tolerances and dimensions 25Optical requirements 25.1 General. 25.2 Dioptric power. 25.3 Imaging quality 25.4 Additional optical characterization. 36Clinical investigation36.1 General. 36.2 Additional requirements for the clinical investigat

23、ion plan. 47Information supplied by the manufacturer 4Annex A (normative) Optical characterization 6Annex B (informative) Clinical investigation. 8Annex C (informative) Determination of sample sizes for the clinical investigation 16Bibliography. 20EN ISO 11979-9:2006BS EN ISO 11979-9:2006+A1:2014EN

24、ISO 11979-9:2006+A1:2014Foreword iv1 Scope 2 Normative references 3 Terms and definitions 4 Physical requirements Text deleted5 Optical requirements 2Text deleted6 Clinical investigation 261 General 262 Additional requirements for the clinical investigation plan 27 Information supplied by the manufa

25、cturer 2Annex A (normative) Optical characterization 3Annex B (informative) Clinical investigation 4Annex C (informative) Determination of sample sizes for the clinical investigation 12Bibliography 16Foreword ISO (the International Organization for Standardization) is a worldwide federation of natio

26、nal standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. Internation

27、al organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules

28、given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least

29、 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 11979-9 was prepared by Technical Committee ISO/TC 172

30、, Optics and photonics, Subcommittee 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 testmethods Part3: Mechanical properties and testmethods Part 4:

31、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 Part10: Phakic intraocularlensesEN ISO 11979-9:2006ivBS EN ISO 11979-9:2006+A1:2014EN ISO 11979-9:2006+A

32、1:20141Ophthalmic implants In traocular lenses Part 9: Multifocal intraocular lenses 1 Scope This part of ISO 11979 is applicable to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primaryindication is the correction of aphakia with the added benefit of

33、useful vision at more than one distance (e.g. far and near).NOTE The term “near vision” as used in this part of ISO 11979 includes useful vision at a distance of claimed benefit;e.g. near and/or intermediate distances. 2 NormativereferencesThe following referenced documents are indispensable for the

34、 application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 11979-2, Ophthalmic implants Intraocul

35、ar lenses Part 2: Optical properties and test methodsISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methodsISO 11979-4, Ophthalmic implants Intraocular lenses Part 4: Labelling and informationISO 11979-7, Ophthalmic implants Intraocular lenses Part 7: Clin

36、ical investigationsISO 14155-1, Clinical investigation of medical devices for human subjects Part1: General requirementsISO 14155-2, Clinical investigation of medical devices for human subjects Part2: Clinical investigation plansISO 14971, Medical devices Application of risk management to medical de

37、vices3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11979-1, ISO 14155-1 and ISO 14155-2 apply.EN ISO 11979-9:20061Ophthalmic implants In traocular lenses Part 9: Multifocal intraocular lenses 1 Scope This part of ISO 11979 is applicable to any intr

38、aocular lens whose optic provides two or more rotationally symmetric powers and whose primaryindication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).NOTE The term “near vision” as used in this part of ISO 11979 includes useful vis

39、ion at a distance of claimed benefit;e.g. near and/or intermediate distances. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referen

40、ceddocument (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methodsISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and te

41、st methodsISO 11979-4, Ophthalmic implants Intraocular lenses Part 4: Labelling and informationISO 11979-7, Ophthalmic implants Intraocular lenses Part 7: Clinical investigationsISO 14155-1, Clinical investigation of medical devices for human subjects Part1: General requirementsISO 14155-2, Clinical

42、 investigation of medical devices for human subjects Part2: Clinical investigation plansISO 14971, Medical devices Application of risk management to medical devices3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11979-1, ISO 14155-1 and ISO 14155-2 a

43、pply.EN ISO 11979-9:2006 BS EN ISO 11979-9:2006+A1:2014EN ISO 11979-9:2006+A1:2014This part of ISO 11979 is applicable to any intraocular lens whose optic provides two or more Text deleted powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceTe