1、March 2013 Translation by DIN-Sprachendienst.English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.040.70!$0x“1961385www.din.deDDIN EN ISO 11980Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations (ISO 11980:2012);English version EN ISO 11980:2012,English translation of DIN EN ISO 11980:2013-03Augenoptik Kontaktlinsen und Kontaktlinsenpflegemitte
3、l Leitfaden fr die klinische Prfung (ISO 11980:2012);Englische Fassung EN ISO 11980:2012,Englische bersetzung von DIN EN ISO 11980:2013-03Optique ophtalmique Lentilles de contact et produits dentretien pour lentilles de contact Directives pour les investigations cliniques (ISO 11980:2012);Version an
4、glaise EN ISO 11980:2012,Traduction anglaise de DIN EN ISO 11980:2013-03SupersedesDIN EN ISO 11980:2010-03www.beuth.deDocument comprises 32 pagesIn case of doubt, the German-language original shall be considered authoritative.02.13DIN EN ISO 11980:2013-03 2 A comma is used as the decimal marker. Nat
5、ional foreword This document (EN ISO 11980:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” (Secretariat: DIN, Germany), in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN,
6、Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 14155 DIN EN ISO 1415
7、5 ISO 14534 DIN EN ISO 14534 ISO 18369-1 DIN EN ISO 18369-1 In Germany, use of the symbol “dpt” for dioptre in 4.2.1.1 and in the tables of Annex A (expressed in m-1) is legally required and this symbol is to be used rather than the symbol D used in other countries. Amendments This standard differs
8、from DIN EN ISO 11980:2010-03 as follows: a) the reference to the horizontal standard relating to clinical investigation has been updated: DIN EN ISO 14155 (formerly DIN EN ISO 14155-1 and DIN EN ISO 14155-2); b) the exclusion criterion in Subclause 4.2.1.1 b) 6) has been rendered more precise; c) i
9、n Table A.1, the number of cases for orthokeratology lenses has been changed; d) the text of the revised version ISO 11980:2012 has been adopted in its entirety. Previous editions DIN EN ISO 11980: 1998-02, 2010-03 National Annex NA (informative) Bibliography DIN EN ISO 14155, Clinical investigation
10、 of medical devices for human subjects Good clinical practice DIN EN ISO 14534, Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements DIN EN ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling sp
11、ecifications EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11980 November 2012 ICS 11.040.70 Supersedes EN ISO 11980:2009English Version Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)Optique ophtalmique - Lentilles
12、 de contact et produits dentretien pour lentilles de contact - Directives pour les investigations cliniques (ISO 11980:2012) Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Leitfaden fr die klinische Prfung (ISO 11980:2012) This European Standard was approved by CEN on 14 November 2012. C
13、EN 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 ap
14、plication 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
15、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, L
16、atvia, 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 Management Centre: Avenue Marnix 17, B-
17、1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11980:2012: EContents PageForeword .Introduction 1 Scope 2 Normative references .3 Terms and definitions .4 Clinical investigational requirements 4.1 General .4
18、.2 Additional requirements 4.3 Other considerations Annex A (informative) Elements of a clinical investigation .Annex B (informative) Procedures for the evaluation of safety, physiological performance and effect on ocular tissues .Annex C (informative) The evaluation of visual, refractive and lens p
19、erformance and subject acceptance .Bibliography .DIN EN ISO 11980:2013-03 EN ISO 11980:2012 (E) 23455555589222730Foreword This document (EN ISO 11980:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic opti
20、cs” 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 May 2013, and conflicting national standards shall be withdrawn at the latest by May 2013. Attention is
21、 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 patent rights. This document supersedes EN ISO 11980:2009. According to the CEN/CENELEC Internal Regulations, the
22、 national standards organisations 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
23、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11980:2012 has been approved by CEN as a EN ISO 11980:2012 without any modification. DIN EN ISO 11980:2013
24、-03 EN ISO 11980:2012 (E) 3 IntroductionCurrently, contact lenses and contact lens care products are regulated in different ways in different countries. This International Standard has been developed to encourage global harmonization. Widespread adoption of this International Standard should represe
25、nt yet another step toward mutual recognition. This International Standard can also be used as a basis to fulfil design elements of ISO 90011.DIN EN ISO 11980:2013-03 EN ISO 11980:2012 (E) 41 ScopeThis International Standard gives guidelines for the clinical investigation (CI) of the safety and perf
26、ormance of contact lenses and contact lens care products.NOTE This International Standard attempts to harmonize the recognized regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However,
27、 national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this International Standard.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated
28、 references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14534, Ophthalmic optics Contact lenses and contact
29、lens care products Fundamental requirementsISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 14155, ISO 14534 and ISO
30、 18369-1 apply.4 Clinical investigational requirements4.1 GeneralThe general requirements for a CI and for a clinical investigation plan (CIP) given in ISO 14155 shall apply, with additional requirements given below.4.2 Additional requirements4.2.1 Study design4.2.1.1 Generala) The inclusion criteri
31、a for subject selection shall relate to the study objectives and should include:1) subjects with normal eyes who are not using any ocular medications, aged 18 years or over except when contact lens investigations have a special indication for use in “children” (for the purposes of this International
32、 Standard, persons less than 18 years of age) such as orthokeratology and paediatric aphakic lenses;2) lens powers within the range available for the test lenses;3) the manifest cylinder less than or equal to 0,75 D (for a study with only spherical power correcting lenses);DIN EN ISO 11980:2013-03 E
33、N ISO 11980:2012 (E) 5 4) best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0,1).b) The exclusion criteria for subject selection shall relate to the study objectives and should include, but not be limited to:1) anterior segment infection, inflammatio
34、n or abnormality;2) any active anterior segment ocular disease that would contraindicate contact lens wear;3) the use of systemic or ocular medications that would contraindicate contact lens wear;4) history of herpetic keratitis;5) history of refractive surgery or irregular cornea (except when the c
35、ontact lenses under investigation are indicated for irregular cornea, keratoconus or refractive surgery);6) slit lamp findings that are more serious than grade 1;7) corneal vascularization greater than 1 mm of penetration;8) a pathologically dry eye;9) participation of the subject in a contact lens
36、or contact lens care product clinical trial within the previous 30 days.c) The CIP shall provide a description of the monitoring procedure to ensure consistent quality of data collection and recording.d) The CIP shall include a statistical analysis plan. Sample size shall be justified, calculated by
37、 a validated statistical software package.4.2.1.2 Contact lenses4.2.1.2.1 General. A CI of contact lenses, including daily wear and extended wear hydrogel, silicone hydrogel, and rigid gas-permeable contact lenses, shall be designed as one of 4.2.1.2.2 or 4.2.1.2.3.For CIPs to demonstrate safety and
38、 performance, as well as special claims (e.g. comfort), labelling or additional indications, the following is required: a pre-determined statistical analysis plan (including sample size calculations) shall be specified in the clinical protocol. Where feasible, the CIP shall define objective endpoint
39、s to help support such claims.NOTE 1 Inter-subject controls are preferred to intra-subject controls due to the potential dependence between the two eyes and concerns regarding subject compliance.NOTE 2 Annex A provides guidance for the design of a CI.4.2.1.2.2 As a prospective, concurrently controll
40、ed study. For investigations evaluating hydrogel, silicone hydrogel or rigid gas-permeable contact lenses, a prospective, concurrent control study design shall be followed. Either a bilateral crossover design or a contra-lateral eye (i.e. intra-subject) design or inter-subject controls shall be util
41、ized. If inter-subject controls are utilized, the ratio of test subjects to control subjects may be either 2:1 or 1:1. The control lens shall be a currently marketed contact lens in use for the same modality. Randomization and masking (subject, investigator and evaluator) shall be employed where pos
42、sible to minimize the potential for bias. Subjects shall be divided evenly between study investigators.4.2.1.2.3 As an uncontrolled study. Here, results are compared to a historical control. Alternative investigational study designs, such as historical controls, shall be utilized when a sponsor has
43、a clinical database on a marketed contact lens to use as a comparator. If any historical control is used, the control group shall be defined and adequately characterized for comparison to the test group. Compatibility of test and control groups shall be demonstrated by comparison of the selection cr
44、iteria, demographics, refractive characteristics, contact lens wearing history and CIPs used.DIN EN ISO 11980:2013-03 EN ISO 11980:2012 (E) 64.2.1.3 Contact lens care productsFor investigations evaluating contact lens care products, a prospective concurrent control study design shall be followed. It
45、 is recommended that the ratio of test to control subjects be either 2:1 or 1:1. The control care product shall be a currently marketed contact lens care product. Randomization and masking (subject, investigator and evaluator) shall be employed where possible to minimize the potential for bias. Subj
46、ects shall be divided evenly between study investigators. Alternative investigational study designs, such as use of historical controls, may be utilized when a manufacturer has a clinical database on a marketed care product to use for comparison. If any historical control is used, the control group
47、should be defined and adequately characterized for comparison to the test group. Compatibility of test and control groups should be demonstrated by comparison of the selection criteria and CIPs used.For CIPs to demonstrate safety and performance, as well as special claims (e.g. comfort), labelling o
48、r additional indications, the following is required for the care products: a pre-determined statistical analysis plan (including sample size calculations) shall be specified in the clinical protocol. Where feasible, the protocol should define objective endpoints to help support such claims.NOTE 1 In
49、ter-subject controls are preferred to intra-subject controls due to the potential dependence between the two eyes and concerns regarding subject compliance.In a contact lens care product investigation, a daily wear schedule shall be followed for most products in order to maximize the subjects exposure to those products. However, a study of a lens or a periodic cleaner, used at weekly
