BS EN ISO 11979-7-2014 Ophthalmic implants Intraocular lenses Clinical investigations《眼科植入物 眼内透镜 临床研究》.pdf

1、BSI Standards PublicationBS EN ISO 11979-7:2014Ophthalmic implants Intraocular lensesPart 7: Clinical investigationsBS EN ISO 11979-7:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11979-7:2014. It supersedes BS EN ISO 11979-7:2006+A1:2012 whichis withd

2、rawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/7, Eye implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are r

3、esponsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 70883 1ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStanda

4、rds Policy and Strategy Committee on 30 September 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-7 September 2014 ICS 11.040.70 Supersedes EN ISO 11979-7:2006English Version Ophthalmic implants - Intraocular lenses - Part 7: C

5、linical investigations (ISO 11979-7:2014) Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques (ISO 11979-7:2014) Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prfungen (ISO 11979-7:2014) This European Standard was approved by CEN on 18 July 2014.

6、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. Up-to-date lists and bibliographical references concerning such national standards may be obtained on a

7、pplication to the CEN-CENELEC 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 its own language and notified to the CEN-CENELEC

8、 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, Germany, Greece, Hungary, Iceland, Ireland, Italy,

9、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue

10、Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-7:2014 EBS EN ISO 11979-7:2014EN ISO 11979-7:2014 (E) 3 Foreword This document (EN ISO 11979-7:2014) has been prepared by Technical Committee

11、 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 identical text or by endorsement, at the latest by

12、 March 2015, and conflicting national standards shall be withdrawn at the latest by March 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such paten

13、t rights. This document supersedes EN ISO 11979-7:2006. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Fin

14、land, 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 and the United Kingdom. Endorsement notice The text of

15、ISO 11979-7:2014 has been approved by CEN as EN ISO 11979-7:2014 without any modification. BS EN ISO 11979-7:2014ISO 11979-7:2014(E) ISO 2014 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Justification for a clinical investigation 15 E

16、thical considerations 16 General requirements . 16.1 General . 16.2 Design . 26.3 Characteristics . 26.4 Investigation duration 46.5 Enrollment 46.6 Bilateral implantation . 46.7 Surgical technique 46.8 Examination and treatment of subjects. 56.9 Adverse events reports 56.10 Inclusion and exclusion

17、criteria . 5Annex A (informative) Elements of a clinical investigation 7Annex B (informative) Evaluation of post-operative adverse event and visual acuity rates .15Annex C (informative) Additional elements for toric IOLs .19Annex D (informative) Additional elements for accommodating IOLs 26Annex E (

18、informative) Clinical tests .35Bibliography .41BS EN ISO 11979-7:2014ISO 11979-7:2014(E)ForewordISO (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 t

19、hrough 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 colla

20、borates 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 are described in the ISO/IEC Directives, Part 1. In particular the different approva

21、l 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. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of

22、 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 on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used i

23、n this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barrie

24、rs to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the third edition (ISO 11979-7:2006), which has

25、been technically revised. It also incorporates the Amendment ISO 11979-7:2006/Amd1:2012 .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 me

26、thods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability testing Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses Part 10: Phakic intraocular lensesiv ISO 2014 All rights reservedBS EN ISO 11979-

27、7:2014INTERNATIONAL STANDARD ISO 11979-7:2014(E)Ophthalmic implants Intraocular lenses Part 7: Clinical investigations1 ScopeThis part of ISO 11979 specifies particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).2 Normative referencesThe fol

28、lowing documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11979-1, Op

29、hthalmic implants Intraocular lenses Part 1: VocabularyISO 11979-10, Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lensesISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14971, Medical devices Application of risk management to med

30、ical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11979-1 and ISO 14155 apply.4 Justification for a clinical investigationIf the need for a clinical investigation is identified, the requirements of ISO 14155 shall apply, with additional requ

31、irements given below.If a new IOL model is a modification of a model for which the safety and performance have been established through clinical investigation in accordance with this part of ISO 11979 no or limited clinical investigation is needed. ISO/TR 229791provides guidance in determining wheth

32、er or not a modification is minor.5 Ethical considerationsFor clinical investigations of medical devices for human subjects, the requirements in ISO 14155 shall apply.6 General requirements6.1 GeneralThe requirements for a clinical investigation given in ISO 14155 shall apply, with additional requir

33、ements given below. ISO 2014 All rights reserved 1BS EN ISO 11979-7:2014ISO 11979-7:2014(E)6.2 Design6.2.1 GeneralA clinical investigation shall be designed to compare results to historical data on adverse events and visual acuity rates. Annex A provides general guidance for the design of a clinical

34、 investigation. Historical data can be found in Annex B.6.2.2 Additional requirements for toric IOLsFor all toric IOLs, the rotational stability of a non-toric version that is mechanically and geometrically equivalent to the toric IOL shall be demonstrated.The following performance criteria for rota

35、tional stability shall be fulfilled: the rotation of the meridian defined by the IOL axis indicator as measured and compared between Day 0 (the day of surgery) post-operative examination and the form 4 examination shall be less than 10 in 90 % of the cases, less than 20 in 95 % of the cases, and les

36、s than 30 in 99 % of the cases.Then, if necessary due to risk analysis, a clinical investigation shall be performed using the toric version of the model.In the event that a toric IOL clinical investigation is required due to risk analysis, the subjects that undergo secondary surgery to correct IOL a

37、xis mark rotation shall have their clinical results prior to the secondary surgery carried forward as the final results for that subject. In the case of examinations scheduled to be performed later in the clinical investigation, the sponsor shall consider requiring each of these examinations to be p

38、erformed prior to the secondary surgery, if possible.Additional elements for toric IOLs are outlined in Annex C.6.2.3 Additional requirements for accommodating IOLsA controlled clinical investigation of an accommodating IOL shall evaluate the additional safety and performance concerns, specifically

39、including the evaluation of accommodative amplitude using at least one objective method. Guidance on clinical investigation of accommodating IOLs is outlined in Annex D. It shall consist of two phases, with phase two beginning only after the first phase has demonstrated that the accommodating IOL pr

40、ovides an average of at least 1 D of objective accommodation. The overall study shall demonstrate that the accommodating IOL also provides 1 D of objective accommodation at the point of stabilization.6.3 CharacteristicsThe clinical investigational plan shall provide information regarding characteris

41、tics to be studied, and instructions regarding the grading and documentation of these characteristics. Whenever possible, objective methods shall be used, such as photographic imaging.The following characteristics shall be considered. If additional claims are to be made, additional corresponding cha

42、racteristics shall be studied.6.3.1 General characteristicsa) best spectacle corrected visual acuity (BSCVA);b) subjective refraction;c) intraocular pressure;d) corneal status;2 ISO 2014 All rights reservedBS EN ISO 11979-7:2014ISO 11979-7:2014(E)e) signs of inflammation:1) anterior chamber cells;2)

43、 anterior chamber flare;3) cystoid macular oedema;4) hypopyon;5) endophthalmitis;f) pupillary block;g) retinal detachment;h) status of anterior and posterior capsule;i) IOL decentration;2j) IOL tilt;2k) IOL discoloration;l) IOL opacity.6.3.2 Toric IOL characteristicsa) uncorrected visual acuity;b) k

44、eratometry;c) IOL mark axis rotation.6.3.3 Accommodating IOL characteristicsa) uncorrected visual acuity at distance, intermediate and near;b) visual acuity at near and intermediate with best distance correction;c) best corrected near visual acuity;d) additional refraction (over best distance subjec

45、tive correction) required to achieve best corrected near acuity;e) objective accommodative amplitude;f) contrast sensitivity;g) subject questionnaire;h) pupil size.6.3.4 Additional characteristicsIf justified by the risk analysis, these additional characteristics shall be considered.a) cycloplegic r

46、efraction;b) specular microscopy;c) gonioscopic examination;d) pupil size; ISO 2014 All rights reserved 3BS EN ISO 11979-7:2014ISO 11979-7:2014(E)e) anterior chamber depth measurement.6.4 Investigation durationThe minimum duration of the clinical investigations shall be one year (see Annex A for vis

47、it window tolerance) for aphakic posterior chamber IOLs which are not modifications of a model for which safety and performance data have been established through clinical investigation.The minimum duration of the clinical investigations shall be three years (see Annex A for visit window tolerance)

48、for aphakic anterior chamber IOLs which are not modifications of a model for which safety and performance data have been established through clinical investigation.For all toric IOLs, a six-month study of the non-toric version of the IOL shall be performed to ensure rotational stability. Then for to

49、ric IOLs that are a modification of an IOL that has met the requirements of all parts of ISO 11979, risk analysis may require that this rotational stability study is followed by a clinical investigation of the actual toric IOL for six months. Toric IOLs that are not a modification of an IOL that has met the requirements of all parts of ISO 11979 shall require a full clinical investigation of one year duration.The minimum study duration for accommodating IOLs through clinical investigation shall be one year but may require up to