EN ISO 11979-10-2018 en Ophthalmic implants - Intraocular lenses - Part 10 Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Ophthalmic implants - Intraocular lensesPart 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyesBS EN ISO 1197910:2018National forewordThis British Standard is the UK implementat

2、ion of EN ISO 1197910:2018. It is identical to ISO 1197910:2018. It supersedes BS EN ISO 1197910:2006+A1:2014, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/7, Eye implants.A list of organizations represented on this committee can be obtained

3、on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 92916 8ICS 11.040.70Compliance with a B

4、ritish Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 1197910:2018EUROPEAN STANDARDN

5、ORME EUROPENNEEUROPISCHE NORMEN ISO 11979-10May 2018ICS 11.040.70 Supersedes EN ISO 1197910:2006, EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 1197910:2018:

6、EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersOphthalmic implants Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 1197910:2018)Implants ophtalmiques Lentilles intraoculaire

7、s Partie 10: Investigations cliniques de lentilles intraoculaires pour la correction de lamtropie des yeux phaques (ISO 1197910:2018)Ophthalmische Implantate Intraokularlinsen Teil 10: Klinische Prfungen von Intraokularlinsen zur Korrektion der Ametrophie in phaken Augen (ISO 1197910:2018)This Europ

8、ean Standard was approved by CEN on 28 February 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Uptodate lists and bibliographical references conc

9、erning such national standards may be obtained on application to the CENCENELEC Management Centre or to any CEN member.This European Standard 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

10、 its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Ger

11、many, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 11979-10:2018 (E)European forewordThis document (EN ISO 119791

12、0:2018) 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 European Standard shall be given the status of a national standard, either by publication of an ide

13、ntical text or by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible

14、for identifying any or all such patent rights.This document supersedes EN ISO 1197910:2006.According to the CENCENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Cze

15、ch 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the Unite

16、d Kingdom.Endorsement noticeThe text of ISO 1197910:2018 has been approved by CEN as EN ISO 1197910:2018 without any modification.2BS EN ISO 1197910:2018ISO 11979-10:2018Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms, definitions and abbreviated terms 23.1 Terms and definitions

17、. 23.2 Abbreviated terms . 24 Optical requirements . 25 Mechanical requirements . 26 Biocompatibility requirements 27 Shelf-life and transport stability requirements . 28 Fundamental requirements 29 Justification for a clinical investigation 310 General clinical requirements 310.1 General . 310.2 De

18、sign of a clinical investigation . 310.2.1 Requirements for all types of phakic IOLs . 310.2.2 Additional requirements for PTIOLs 310.2.3 Additional requirements for PMIOLs . 410.3 Characteristics . 410.3.1 General 410.3.2 Characteristics applying to the clinical evaluations for all types of phakic

19、IOLs . 410.3.3 Additional characteristics applying to PTIOLs . 510.3.4 Additional characteristics applying to PMIOLs . 510.4 Duration of the investigation 510.5 Enrolment 510.6 Bilateral implantation . 510.7 Surgical technique 610.8 Examination and treatment of subjects. 610.9 Adverse events reports

20、 610.10 Inclusion and exclusion criteria . 610.10.1 General criteria for all phakic IOLs 610.10.2 Additional criteria for PTIOLs 910.10.3 Additional criteria for multifocal IOLs 911 Information supplied by the manufacturer . 9Annex A (informative) Elements in a phakic IOL clinical investigation 10An

21、nex B (informative) Statistical methods and sample size calculations 16Bibliography .17 ISO 2018 All rights reserved iiiContents PageBS EN ISO 1197910:2018ISO 11979-10:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO mem

22、ber 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, governmen

23、tal and nongovernmental, 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. The procedures used to develop this document and those intended for its further maintenance

24、are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is

25、 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or

26、 on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and exp

27、ressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 172, Optics a

28、nd photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO 11979-10:2006) and its amendment (ISO 1197910:2006/Amd 1:2014), which has been technically revised.The main changes compared to the previous edition are as follows. modi

29、fied the scope to include phakic multifocal and phakic toric intraocular lenses; added references to the requirements in ISO 11979-6, ISO 11979-7, andISO 11979-8; modified the clinical requirements to include those for phakic multifocal and phakic toric intraocular lenses; and modified the informati

30、ve Annex A to include elements associated with the clinical investigation of phakic multifocal and phakic toric intraocular lenses.A list of all parts in the ISO 11979 series can be found on the ISO website.iv ISO 2018 All rights reservedBS EN ISO 1197910:2018ISO 11979-10:2018IntroductionPhakic intr

31、aocular lenses are used to correct refractive errors in patients with a noncataractous crystalline lens. They are typically used for patients with higher amounts of myopia or hyperopia. Originally, they contained a spherical monofocal optic to correct spherical errors but later variations utilized a

32、 toric optic to also correct refractive astigmatism. Phakic intraocular lenses with a multifocal optic can be used to correct presbyopia in patients that have lost the ability to accommodate.The requirements and recommendations in the ISO series of standards for aphakic intraocular lenses for the mo

33、st part also apply to phakic intraocular lenses. Those standards should be reviewed for guidance that would also be applicable to phakic intraocular lenses (e.g. shelflife testing, biocompatibility testing, etc.).This document provides requirements and recommendations for phakic intraocular lens inv

34、estigations of new models. Risk analysis should be used to determine the investigational design, if needed, for models that are modifications of parent phakic models. For modifications of a parent phakic model refer to ISO/TR 22979. ISO 2018 All rights reserved vBS EN ISO 1197910:2018This page delib

35、erately left blankOphthalmic implants - Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes1 ScopeThis document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indic

36、ation to modify its refractive power.There are three main categories of phakic intraocular lenses depending on the optical design:a) Phakic monofocal (PIOL);b) Phakic multifocal (PMIOL); andc) Phakic toric (PTIOL).Each of these categories is further designated for implantation in either the anterior

37、 or posterior chamber of the anterior segment of the eye.The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.This document addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.2

38、Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including an

39、y amendments) applies.ISO 119791, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 119792, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methodsISO 119793, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methodsISO 119794, Ophtha

40、lmic implants Intraocular lenses Part 4: Labelling and informationISO 119795, Ophthalmic implants Intraocular lenses Part 5: BiocompatibilityISO 119796, Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testingISO 119797, Ophthalmic implants Intraocular lenses Part 7:

41、 Clinical investigations of lenses for the correction of aphakiaISO 119798, Ophthalmic implants Intraocular lenses Part 8: Fundamental requirementsISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14971, Medical devices Application of risk management t

42、o medical devicesINTERNATIONAL STANDARD ISO 11979-10:2018 ISO 2018 All rights reserved 1BS EN ISO 1197910:2018ISO 11979-10:20183 Terms, definitions and abbreviated terms3.1 Terms and definitionsFor the purposes of this document the terms and definitions given in ISO 11979-1 and ISO 14155 apply.ISO a

43、nd IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.2 Abbreviated termsUDVA uncorrected distance visual acuityUIVA uncorrected int

44、ermediate visual acuityUNVA uncorrected near visual acuityCDVA corrected distance visual acuityCIVA corrected intermediate visual acuityCNVA corrected near visual acuityDCIVA distance corrected intermediate visual acuityDCNVA distance corrected near visual acuity4 Optical requirementsThe applicable

45、requirements of ISO 119792 shall apply.5 Mechanical requirementsThe applicable requirements of ISO 119793 shall apply.6 Biocompatibility requirementsThe applicable requirements of ISO 119795 shall apply.7 Shelf-life and transport stability requirementsThe requirements of ISO 119796 shall apply.8 Fun

46、damental requirementsThe requirements of ISO 119798 shall apply.2 ISO 2018 All rights reservedBS EN ISO 1197910:2018ISO 11979-10:20189 Justification for a clinical investigationA risk analysis shall be implemented in accordance with ISO 14971. If the risk analysis identifies the need for a clinical

47、investigation, the requirements of ISO 14155 shall apply, with additional requirements given in this document.If a new phakic IOL model is a modification of a parent phakic IOL for which the safety and performance have already been established through clinical investigation in accordance with this d

48、ocument, then a limited or no additional clinical investigation can suffice. ISO/TR 229791provides guidance in determining the need for a clinical investigation.10 General clinical requirements10.1 GeneralThe requirements for a clinical investigation given in ISO 14155 shall apply, with additional r

49、equirements given below.10.2 Design of a clinical investigation10.2.1 Requirements for all types of phakic IOLsA noncontrolled clinical investigation shall be designed to investigate the safety and performance of PIOL designs, and PTIOL designs of higher cylinder power.A controlled clinical investigation shall be designed to investigate the safety and performance of PMIOL designs, and PTIOL designs of lower cylinder power (i.e. cylinder powers of 1,5 D or less).Th