SVENSK STANDARD SS-EN ISO :2018

Transcription

1 SVENSK STANDARD SS-EN ISO :2018 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 2 Språk/Language: engelska/english ICS: Ögonimplantat Intraokulära linser Del 10: Linser för implantation i faka ögon Kliniska prövningar för Intraokulära linser för korrektion av ametropi i faka ögon (ISO :2018) Ophthalmic implants Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO :2018)

2 Standarder får världen att fungera SIS (Swedish Standards Institute) är en fristående ideell förening med medlemmar från både privat och offentlig sektor. Vi är en del av det europeiska och globala nätverk som utarbetar internationella standarder. Standarder är dokumenterad kunskap utvecklad av framstående aktörer inom industri, näringsliv och samhälle och befrämjar handel över gränser, bidrar till att processer och produkter blir säkrare samt effektiviserar din verksamhet. Delta och påverka Som medlem i SIS har du möjlighet att påverka framtida standarder inom ditt område på nationell, europeisk och global nivå. Du får samtidigt tillgång till tidig information om utvecklingen inom din bransch. Ta del av det färdiga arbetet Vi erbjuder våra kunder allt som rör standarder och deras tillämpning. Hos oss kan du köpa alla publikationer du behöver allt från enskilda standarder, tekniska rapporter och standardpaket till handböcker och onlinetjänster. Genom vår webbtjänst e-nav får du tillgång till ett lättnavigerat bibliotek där alla standarder som är aktuella för ditt företag finns tillgängliga. Standarder och handböcker är källor till kunskap. Vi säljer dem. Utveckla din kompetens och lyckas bättre i ditt arbete Hos SIS kan du gå öppna eller företagsinterna utbildningar kring innehåll och tillämpning av standarder. Genom vår närhet till den internationella utvecklingen och ISO får du rätt kunskap i rätt tid, direkt från källan. Med vår kunskap om standarders möjligheter hjälper vi våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter. Vill du veta mer om SIS eller hur standarder kan effektivisera din verksamhet är du välkommen in på eller ta kontakt med oss på tel Standards make the world go round SIS (Swedish Standards Institute) is an independent non-profit organisation with members from both the private and public sectors. We are part of the European and global network that draws up international standards. Standards consist of documented knowledge developed by prominent actors within the industry, business world and society. They promote cross-border trade, they help to make processes and products safer and they streamline your organisation. Take part and have influence As a member of SIS you will have the possibility to participate in standardization activities on national, European and global level. The membership in SIS will give you the opportunity to influence future standards and gain access to early stage information about developments within your field. Get to know the finished work We offer our customers everything in connection with standards and their application. You can purchase all the publications you need from us - everything from individual standards, technical reports and standard packages through to manuals and online services. Our web service e-nav gives you access to an easy-to-navigate library where all standards that are relevant to your company are available. Standards and manuals are sources of knowledge. We sell them. Increase understanding and improve perception With SIS you can undergo either shared or in-house training in the content and application of standards. Thanks to our proximity to international development and ISO you receive the right knowledge at the right time, direct from the source. With our knowledge about the potential of standards, we assist our customers in creating tangible benefit and profitability in their organisations. If you want to know more about SIS, or how standards can streamline your organisation, please visit or contact us on phone +46 (0)

3 Europastandarden EN ISO :2018 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO :2018. Denna standard ersätter SS-EN ISO :2006, utgåva 1 och SS-EN ISO :2006 / A1:2014, utgåva 1. The European Standard EN ISO :2018 has the status of a Swedish Standard. This document contains the official version of EN ISO :2018. This standard supersedes the Swedish Standard SS-EN ISO :2006, edition 1 and SS-EN ISO :2006 / A1:2014, edition 1. Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone Standards may be ordered from SIS, who can also provide general information about Swedish and foreign standards. Denna standard är framtagen av kommittén för Ögonoptik, SIS / TK 336. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på - där hittar du mer information.

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5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM Provläsningsexemplar / Preview EN ISO May 2018 ICS Supersedes EN ISO :2006 English Version Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO :2018) Implants ophtalmiques - Lentilles intraoculaires - Partie 10: Investigations cliniques de lentilles intraoculaires pour la correction de l'amétropie des yeux phaques (ISO :2018) Ophthalmische Implantate - Intraokularlinsen - Teil 10: Klinische Prüfungen von Intraokularlinsen zur Korrektion der Ametrophie in phaken Augen (ISO :2018) This European Standard was approved by CEN on 28 February 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 application 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 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO :2018 E

6 Contents Page European foreword...iv Introduction...v 1 Scope Normative references Terms, definitions and abbreviated terms Terms and definitions Abbreviated terms Optical requirements Mechanical requirements Biocompatibility requirements Shelf-life and transport stability requirements Fundamental requirements Justification for a clinical investigation General clinical requirements General Design of a clinical investigation Requirements for all types of phakic IOLs Additional requirements for PTIOLs Additional requirements for PMIOLs Characteristics General Characteristics applying to the clinical evaluations for all types of phakic IOLs Additional characteristics applying to PTIOLs Additional characteristics applying to PMIOLs Duration of the investigation Enrolment Bilateral implantation Surgical technique Examination and treatment of subjects Adverse events reports Inclusion and exclusion criteria General criteria for all phakic IOLs Additional criteria for PTIOLs Additional criteria for multifocal IOLs Information supplied by the manufacturer... 9 Annex A (informative) Elements in a phakic IOL clinical investigation...10 Annex B (informative) Statistical methods and sample size calculations...16 Bibliography...17 iii

7 European foreword This document (EN ISO :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 identical text or by endorsement, at the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 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 for identifying any or all such patent rights. This document supersedes EN ISO :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, 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 United Kingdom. Endorsement notice The text of ISO :2018 has been approved by CEN as EN ISO :2018 without any modification. iv

8 Introduction Phakic intraocular lenses are used to correct refractive errors in patients with a non-cataractous 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 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 most 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. shelf-life testing, biocompatibility testing, etc.). This document provides requirements and recommendations for phakic intraocular lens investigations 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 v

9 Ophthalmic implants Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes 1 Scope This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication 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); and c) Phakic toric (PTIOL). Each of these categories is further designated for implantation in either the anterior 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 Normative references The 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 any amendments) applies. ISO , Ophthalmic implants Intraocular lenses Part 1: Vocabulary ISO , Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods ISO , Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods ISO , Ophthalmic implants Intraocular lenses Part 4: Labelling and information ISO , Ophthalmic implants Intraocular lenses Part 5: Biocompatibility ISO , Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing ISO , Ophthalmic implants Intraocular lenses Part 7: Clinical investigations of lenses for the correction of aphakia ISO , Ophthalmic implants Intraocular lenses Part 8: Fundamental requirements ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice ISO 14971, Medical devices Application of risk management to medical devices 1

10 3 Terms, definitions and abbreviated terms 3.1 Terms and definitions For the purposes of this document the terms and definitions given in ISO and ISO apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at ISO Online browsing platform: available at obp 3.2 Abbreviated terms UDVA UIVA UNVA CDVA CIVA CNVA DCIVA DCNVA uncorrected distance visual acuity uncorrected intermediate visual acuity uncorrected near visual acuity corrected distance visual acuity corrected intermediate visual acuity corrected near visual acuity distance corrected intermediate visual acuity distance corrected near visual acuity 4 Optical requirements The applicable requirements of ISO shall apply. 5 Mechanical requirements The applicable requirements of ISO shall apply. 6 Biocompatibility requirements The applicable requirements of ISO shall apply. 7 Shelf-life and transport stability requirements The requirements of ISO shall apply. 8 Fundamental requirements The requirements of ISO shall apply. 2

11 9 Justification for a clinical investigation A risk analysis shall be implemented in accordance with ISO If the risk analysis identifies the need for a clinical investigation, the requirements of ISO 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 document, then a limited or no additional clinical investigation can suffice. ISO/TR [1] provides guidance in determining the need for a clinical investigation. 10 General clinical requirements 10.1 General The requirements for a clinical investigation given in ISO shall apply, with additional requirements given below Design of a clinical investigation Requirements for all types of phakic IOLs A non-controlled 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). The primary safety endpoint for all phakic IOL investigations is endothelial cell density. NOTE In the case of the non-controlled clinical investigations, data describing changes in endothelial cell density over time for levels of ametropia similar to the levels for the subjects in the investigation from either literature or from a sub-study of non-operated eyes will be useful in assessing the significance of the endothelial cell density changes in the study subjects Additional requirements for PTIOLs During the clinical investigation of a PTIOL, the rotational stability shall be demonstrated. The following performance criteria for rotational stability shall be fulfilled: The IOL rotation is defined as the difference in postoperative orientation of the meridian defined by the IOL axis indicator between that intended on the day of surgery and that measured at the final reporting period for the investigation. Absolute rotation shall be less than 10 in 90 % of the cases, and less than 20 in 95 % of the cases. The clinical performance of low cylinder power PTIOLs shall be demonstrated compared to the nontoric control PIOL. In such a clinical investigation, subjects that undergo secondary surgery to correct postoperative phakic IOL rotational misalignment shall have their clinical results prior to the secondary surgery carried forward as the final results for that subject, and examinations scheduled to be performed later in the clinical investigation be performed prior to the secondary surgery, if possible. The TIOL clinical design provisions in ISO shall be used to determine the additional evaluations needed to be incorporated into the general phakic clinical investigational design described in Annex A to evaluate the performance of the PTIOL design. 3