SVENSK STANDARD SS-EN ISO 11984 Handläggande organ Fastställd Utgåva Sida Hälso- och sjukvårdsstandardiseringen, HSS 2000-03-17 1 1 (1+11) Copyright SIS. Reproduction in any form without permission is prohibited. Ophthalmic optics Contact lenses Determination of rigid lens flexure and breakage Ögonoptik Kontaktlinser Bestämning av böjning och brottstyrka hos hårda linser The European Standard EN ISO 11984:1999 has the status of a Swedish Standard. This document contains the official English version of EN ISO 11984:1999. Swedish Standards corresponding to documents referred to in this Standard are listed in Catalogue of Swedish Standards, issued by SIS. The Catalogue lists, with reference number and year of Swedish approval, International and European Standards approved as Swedish Standards as well as other Swedish Standards. Europastandarden EN ISO 11984:1999 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 11984: 1999. Motsvarigheten och aktualiteten i svensk standard till de publikationer som omnämns i denna standard framgår av Katalog över svensk standard, som ges ut av SIS. I katalogen redovisas internationella och europeiska standarder som fastställts som svenska standarder och övriga gällande svenska standarder. ICS 11.040.70 Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Postadress: SIS, Box 6455, 113 82 STOCKHOLM Telefon: 08-610 30 00. Telefax: 08-30 77 57 E-post: sis.sales@sis.se. Internet: www.sisforlag.se Upplysningar om sakinnehållet i standarden lämnas av HSS. Telefon: 08-702 49 00. Telefax: 08-702 49 15 E-post: hss@hss.se Prisgrupp N Tryckt i juni 2000
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 11984 December 1999 ICS 11.040.70 English version Ophthalmic optics - Contact lenses - Determination of rigid lens flexure and breakage Optique ophtalmique - Lentilles de contact - Détermination de la flexion et de la rupture des lentilles de contact rigides Augenoptik - Kontaktlinsen - Bestimmung des Verhaltens formstabiler Kontaktlinsen bei Biegung bis hin zum Bruch This European Standard was approved by CEN on 27 November 1999. 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 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 translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11984:1999 E
Page 2 EN ISO 11984:1999 Provläsningsexemplar / Preview Contents Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 4 4 Test method... 6 4.1 Principle... 6 4.2 Sampling... 6 4.3 Preparation of samples... 6 4.4 Apparatus... 7 4.5 Procedure... 8 4.6 Results... 9 4.7 Test report... 9 Bibliography... 11
Page 3 EN ISO 11984:1999 Foreword The text of the International Standard ISO 11984:1999 has been prepared by Technical Committee ISO/TC 172 "Optics and optical instruments" 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 June 2000, and conflicting national standards shall be withdrawn at the latest by June 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTE FROM CEN/CS: The foreword is susceptible to be amended on reception of the German language version. The confirmed or amended foreword, and when appropriate, the normative annex ZA for the references to international publications with their relevant European publications will be circulated with the German version. Endorsement notice The text of the International Standard ISO 11984:1999 was approved by CEN as a European Standard without any modification.
Page 4 EN ISO 11984:1999 Provläsningsexemplar / Preview Ophthalmic optics Contact lenses Determination of rigid lens flexure and breakage 1 Scope This International Standard describes a method for determining the flexural properties of finished rigid contact lenses when tested under specified conditions. The existence of this International Standard does not imply in any way that the testing of contact lenses for flexure and breakage is a requirement. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 8320:1986, Optics and optical instruments Contact lenses Vocabulary and symbols. ISO 9337-1, Contact lenses Determination of back vertex power Part 1: Method using focimeter with manual focusing. ISO 9337-2, Contact lenses Determination of back vertex power Part 2: Measurement on contact lenses immersed in saline. ISO 9338:1996, Optics and optical instruments Contact lenses Determination of diameters. ISO 9339-1, Optics and optical instruments Contact lenses Determination of thickness Part 1: Rigid contact lenses. ISO 10338:1996, Optics and optical instruments Contact lenses Determination of curvature. ISO 10344:1996, Optics and optical instruments Contact lenses Saline solution for contact lens testing. 3 Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 8320 apply, together with the following. 3.1 flexural deformation reduction of the diameter of the contact lens due to a load applied to the edge of the contact lens, perpendicular to the lens axis, to induce flexure NOTE It is expressed as a percentage of the original lens diameter.