1、BRITISH STANDARD BS EN ISO11979-10:2006Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lensesICS 11.040.70nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nullnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nullnull nullnullnullnullnull
2、nullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnull+A1:2014National forewordThis British Standard is the UK implementation of EN ISO 11979-10:2006+A1:2014. It is identical to ISO 11979-10:2006, incorporating amendment 1:2014. It supersedes BS EN ISO 11979-10:2006, which is wi
3、thdrawn.The start and finish of text introduced or altered by amendment 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 b
4、y Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/7, Eye implants.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible
5、for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 11979-10:2006+A1:2014This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 29 September 2006Amendments/corrigenda issued since public
6、ationDate Comments 30 September 2014 Implementation of ISO amendment 1:2014 with CEN endorsement A1:2014ISBN 978 0 580 82538 5 The British Standards Institution 2014. Published by BSI Standards Limited 2014EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMICS 11.040.70English VersionOphthalmic implants
7、 - Intraocular lenses - Part 10: Phakicintraocular lenses (ISO 11979-10:2006)Implants ophtalmiques - Lentilles intraoculaires - Partie 10:Lentilles intraoculaires phaques (ISO 11979-10:2006)Ophthalmische Implantate - Intraokularlinsen - Teil 10:Phake Intraokularlinsen (ISO 11979-10:2006)This Europea
8、n Standard was approved by CEN on 7 August 2006.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 concerni
9、ng such nationalstandards may be obtained on application to the Central Secretariat 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 langua
10、ge and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
11、 Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitati
12、on in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11979-10:2006: EEN ISO 11979-10:2006+A1August 2014This European Standard shall be given the status of a national standard, either by publication of an identicalat the latest by February2007. According to the C
13、EN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland a
14、nd United Kingdom. Endorsement notice The text of ISO 11979-10:2006 has been approved byCEN as EN ISO 11979-10:2006 without any modifications. This document (EN ISO 11979-10:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with Technical Com
15、mittee CEN/TC 170 “Ophthalmic optics“, the secretariat of which is held by DIN.textor by endorsement, at the latestby February2007, and conflicting national standards shall be withdrawn Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, This docu
16、ment (EN ISO 11979-10:2006/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 11979-10:2006 shall be given
17、 the status of a national 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
18、 be the subject of 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,
19、 Belgium, Bulgaria, 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, S
20、witzerland, Turkey and the United Kingdom. The text of ISO 11979-10:2006/A1:2014 has been approved by CEN as EN ISO 11979-10:2006/A1:2014 without any modification. Endorsement notice Foreword to amendment A1ForewordBS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)Reference numberISO 1
21、1979-10:2006(E)INTERNATIONAL STANDARDISO11979-10First edition2006-08-15Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses Implants ophtalmiques Lentilles intraoculaires Partie 10: Lentilles intraoculaires phaquesBS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)i
22、i iiiContents PageForeword iv1Scope. 12Normative references. 13Terms and definitions. 14Optical requirements 15Mechanical requirements.26Clinical investigation26.1 General. 26.2 Clinical assessments 26.3 Other considerations 37Information supplied by the manufacturer 4Annex A (informative) Clinical
23、investigation. 5Annex B (informative) Statistical sample sizeconsiderations 15Bibliography. 18BS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)!Text deleted“iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
24、 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. International organizations, governm
25、ental 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 given in the ISO/IEC Dire
26、ctives, 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 byat least 75 % of the member bodies
27、 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 11979-10 was prepared by Technical Committee ISO/TC 172, Optics and photonics, S
28、ubcommittee 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: Labelling and informatio
29、n 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 intraocularlensesBS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)1Ophthalmic implants Intraocular
30、 lenses Part 10: Phakic intraocular lenses 1 Scope This part of ISO11979 is applicable to any intraocular lens (IOL) whose primaryindication is the modificationof the refractive power of a phakic eye .This part of ISO11979 addresses specific requirements for PIOLs not addressed in the other parts of
31、 ISO 11979. 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 referenceddocument (including anyamendments) applies.ISO 11979-1, Ophthal
32、mic 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 test methodsISO 11979-4, Ophthalmic implants Intraocular lenses Part
33、4: Labelling and information3 Terms and definitions 4 Optical requirements!“For the purposes of this document, the terms and defi nitions given in ISO 11979-1 !ISO 14155 “ applies.!The requirements of ISO 11979-2 apply.“!Text deleted“!ISO 14155, Clinical investigation of medical devices for human su
34、bjects Good clinical practice“BS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)2 5 Mechanical requirements 6 Clinical investigation 6.1 General NOTE Annex A of this part of ISO 11979 contains suggested details concerning a clinical investigation.6.2 Clinical assessments The following
35、assessments shall be considered for the clinical investigation plan: a) visual acuity(VA); b) refraction; c) contrastsensitivity;d) intraocular pressure; e) corneal status; f) iritis; g) IOL decentration; h) IOL tilt; i) IOL discoloration; The general requirements for a clinical investigation given
36、in !ISO 14155“ and the clinical investigation plan requirements in !ISO 14155“ apply. Additional requirements are given in 6.2 and in 6.3.!The requirements of ISO 11979-3 apply.“BS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)3j) IOL opacity;k) cystoid macular edema; l) hypopyon;m) e
37、ndophthalmitis;n) pupillaryblock;o) retinal detachment; p) status of crystalline lens; q) status of anterior chamber angle; r) status of iris; s) pupilsize;t) corneal thickness.6.3 Other considerations Tominimize the risks associated with the clinical investigation of a new PIOL, subject enrollment
38、shall occur instages. The subject data from each stage shall be evaluated and found acceptable by the sponsor and theprincipal investigator prior to the continuation of the clinical investigation. Guidance on phased enrollment isincluded in Annex A. Any plans for fellow eye implantation shall be des
39、cribed in the clinical investigation plan. Bilateral implantation shall not be implemented until initial safetyand performance data have been collected and evaluated bythesponsor and the principal investigator. The review of data from at least 50eyes with six months offollow-up is recommended. Previ
40、ous clinical experience, i.e. results from well-documented clinical investigations, could be adequate justification to begin bilateral implantation earlier in the study.The clinical investigation plan shall contain descriptions of the surgical technique, the intraoperative use of ophthalmic viscosur
41、gical devices, and the use of preoperative, intraoperative and postoperative medications.Any variations from these recommendations shall be recorded on the case report forms.All subjects in a clinical investigation shall be monitored for the duration of the investigation. The clinical investigation
42、shall be considered completed when all subjects that have been enrolled in the investigation, including subjects whose PIOL was removed or replaced, have reached the final reporting period. Serious ophthalmic adverse events and all adverse device effects shall be reported using a special casereport
43、form and forwarded to the sponsor for investigation. A drop in best spectacle corrected visual acuity of two or more lines shall be considered a serious ophthalmic adverse event. All other ophthalmic adverseevents shall be reported using the standard visit case report forms and are collected during
44、monitoring. If a specific calculation procedure is to be used to determine the appropriate power for implantation, the calculation procedure and its derivation shall also be included in the clinical investigation plan. Clinical datashall be evaluated at intervals during the investigation to refine t
45、he power calculation procedure, if necessary.BS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)4 7 Information supplied by the manufacturer !The requirements of ISO 11979-4 together with ISO 11979-4:2008/Amd.1:2012 apply.“BS EN ISO 11979-10:2006+A1:2014 EN ISO 11979-10:2006+A1:2014 (E)
46、5Annex A(informative) Clinical investigationA.1 Objectives The objectives of the clinical investigation are to determine the safetyand performance of the PIOL. A.2 Design The type of clinical investigation recommended is a non-controlled study.The clinical investigation plan should describe how subj
47、ect visits in between reporting periods will be handled. Each investigator should contribute a minimum of 20 subjects, but not more than 25 % of the subjects in the study.A minimum study duration of three years is recommended to adequatelyevaluate the maintenance of endothelial cell density and the
48、rate of cataract development. The clinical investigation plan should informsubjects and investigators that longer term follow-up could be necessary. Guidance for accountability is provided in ISO 11979-7 4. A.2.1 Primary endpointThe recommended primaryendpoint is endothelial cell density.The null hy
49、pothesis is that the true rate of decrease in endothelial cell densityis less than or equal to thenormal rate. The alternative hypothesis is that the true rate is greater than the normal rate. Sample size guidance using this endpoint is provided in Annex B. A.2.2 Inclusion and exclusion criteria A.2.2.1 Inclusion criteria The following inclusion criteria for subjects should be considered: a) subject meets specified refractive criteria (spherical and cylindrical components); b) subject has specified minimum best spectacle corrected vi
