EN ISO 8321-1:2002
(Main)Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 1: Rigid corneal and scleral contact lenses (ISO 8321-1:2002)
Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 1: Rigid corneal and scleral contact lenses (ISO 8321-1:2002)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
Augenoptik - Anforderungen an die Materialeigenschaften, optischen Eigenschaften und Maße von Kontaktlinsen - Teil 1: Formstabile Korneal- und Skleralkontaktlinsen (ISO 8321-1:2002)
Dieser Teil von ISO 8321 legt Anforderungen an formstabile Korneal- und Skleralkontaktlinsen einschließlich Grenz-abweichungen für Materialeigenschaften, optische Eigenschaften und Maße fest.
Eine Schreibweise für die Spezifikation von Kontaktlinsen ist in Anhang A angegeben.
Optique ophtalmique - Spécifications relatives aux propriétés des matériaux et aux propriétés optiques et dimensionelles des lentilles de contact - Partie 1: Lentilles cornéennes et verres scléraux rigides (ISO 8321-1:2002)
Očesna optika - Specifikacije za materiale, optične in dimenzijske lastnosti kontaktnih leč - 1. del: Trde roženične (kornealne) in beločnične (skleralne) kontaktne leče (ISO 8321-1:2002)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Anforderungen an die Materialeigenschaften, optischen Eigenschaften und Maße von Kontaktlinsen - Teil 1: Formstabile Korneal- und Skleralkontaktlinsen (ISO 8321-1:2002)Optique ophtalmique - Spécifications relatives aux propriétés des matériaux et aux propriétés optiques et dimensionelles des lentilles de contact - Partie 1: Lentilles cornéennes et verres scléraux rigides (ISO 8321-1:2002)Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 1: Rigid corneal and scleral contact lenses (ISO 8321-1:2002)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 8321-1:2002SIST EN ISO 8321-1:2002en01-november-2002SIST EN ISO 8321-1:2002SLOVENSKI
STANDARDSIST EN ISO 8321-1:20001DGRPHãþD
SIST EN ISO 8321-1:2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 8321-1September 2002ICS 11.040.70Supersedes EN ISO 8321-1:1996English versionOphthalmic optics - Specifications for material, optical anddimensional properties of contact lenses - Part 1: Rigid cornealand scleral contact lenses (ISO 8321-1:2002)Optique ophtalmique - Spécifications relatives auxpropriétés des matériaux et aux propriétés optiques etdimensionelles des lentilles de contact - Partie 1: Lentillescornéennes et verres scléraux rigides (ISO 8321-1:2002)Augenoptik - Anforderungen an die Materialeigenschaften,optischen Eigenschaften und Maße von Kontaktlinsen - Teil1: Formstabile Korneal- und Skleralkontaktlinsen (ISO8321-1:2002)This European Standard was approved by CEN on 28 July 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 8321-1:2002 ESIST EN ISO 8321-1:2002
EN ISO 8321-1:2002 (E)2CORRECTED
2002-10-09ForewordThis document (EN ISO 8321-1:2002) has been prepared by Technical Committee ISO/TC172 "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 publicationof an identical text or by endorsement, at the latest by February 2003, and conflicting nationalstandards shall be withdrawn at the latest by February 2003.This document supersedes EN ISO 8321-1:1996.For relationship with EU Directive(s), see informative Annex ZB, which is an integral part ofthis document.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium,Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and theUnited Kingdom.Endorsement noticeThe text of ISO 8321-1:2002 has been approved by CEN as EN ISO 8321-1:2002 without anymodifications.NOTE
Normative references to International Standards are listed in Annex ZA (normative).SIST EN ISO 8321-1:2002
EN ISO 8321-1:2002 (E)3Annex ZA(normative)Normative references to international publicationswith their relevant European publicationsThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text and thepublications are listed hereafter. For dated references, subsequent amendments to or revisionsof any of these publications apply to this European Standard only when incorporated in it byamendment or revision. For undated references the latest edition of the publication referred toapplies (including amendments).NOTE Where an International Publication has been modified by common modifications,indicated by (mod.), the relevant EN/HD applies.PublicationYearTitleENYearISO 8320-12001Contact lenses and contact lenscare products - Vocabulary - Part 2:Contact lens care productsEN ISO 8320-12001ISO 85991994Optics and optical instruments -Contact lenses - Determination ofthe spectral and luminoustransmittanceEN ISO 85991996ISO 9337-11999Contact lenses - Determination ofback vertex power - Part 1: Methodusing focimeter with manualfocusingEN ISO 9337-12000ISO 93381996Optics and optical instruments -Contact lenses - Determination ofthe diametersEN ISO 93381998ISO 9339-11996Optics and optical instruments -Contact lenses - Determination ofthe thickness - Part 1: Rigid contactlensesEN ISO 9339-11998ISO 93401996Optics and optical instruments -Contact lenses - Determination ofstrains for rigid contact lensesEN ISO 93401998ISO 93411996Optics and optical instruments -Contact lenses - Determination ofinclusions and surfaceimperfections for rigid contactlensesEN ISO 93411998SIST EN ISO 8321-1:2002
EN ISO 8321-1:2002 (E)4ISO 9913-11996Ophthalmic optics - Contact lenses- Determination of oxygenpermeability and transmissibilitywith the FATT methodEN ISO 9913-11998ISO 9913-22000Ophthalmic optics - Contact lenses- Determination of oxygenpermeability and transmissibility bythe coulometric methodEN ISO 9913-22000ISO 99141995Optics and optical instruments -Contact lenses - Determination ofrefractive index of contact lensmaterialsEN ISO 99141996ISO 103381996Optics and optical instruments -Contact lenses - Determination ofcurvatureEN ISO 103381997SIST EN ISO 8321-1:2002
EN ISO 8321-1:2002 (E)5ANNEX ZB(informative)A-deviationsA-deviation: National deviation due to regulations, the alteration of which is for the time beingoutside the competence of the CEN/CENELEC member.This European Standard does not fall under any Directive of the EC. In the relevantCEN/CENELEC countries these A-deviations are valid instead of the provisions of theEuropean Standard until they have been removed.The legislative situation in Germany requires the unit "dioptre" be designated by the symbol"dpt" instead of "D".This is to avoid conflict with the rules of ISO 1000 being the basic International Standard onsymbols and units and with the respective basic resolution of the CGPM (InternationalConference on Weights and Mesures).Identification of the regulation:Gesetz über die Einheiten im Messwesen vom 02.07.1969 in der Fassung der Bekannt-machung vom 22.04.1985;
andAusführungsverordnung zum Gesetz über Einheiten im Messwesen (Einheitenverordnung -EinhV) vom 13.12.1985, § 1 und Anlage 1, Nr. 9.SIST EN ISO 8321-1:2002
SIST EN ISO 8321-1:2002
Reference numberISO 8321-1:2002(E)© ISO 2002
INTERNATIONAL STANDARD ISO8321-1Second edition2002-09-15Ophthalmic optics — Specifications for material, optical and dimensional properties of contact lenses — Part 1: Rigid corneal and scleral contact lenses Optique ophtalmique — Spécifications relatives aux propriétés des matériaux et aux propriétés optiques et dimensionnelles des lentilles de contact — Partie 1: Lentilles cornéennes et verres scléraux rigides
SIST EN ISO 8321-1:2002
ISO 8321-1:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO 8321-1:2002
ISO 8321-1:2002(E) © ISO 2002 – All rights reserved iii Contents Page Foreword.iv 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Requirements for dimensions and optical properties.2 4.1 Tolerances.2 4.2 Test methods.2 4.3 Conditioning of contact lenses prior to testing.2 4.4 Additional properties.2 5 Requirements for finish.2 5.1 Inclusions and surface imperfections.2 5.2 Strains.2 5.3 Fenestrations.3 5.4 Edge contour and finish.3 Annex A (informative)
Recommended method for presenting the specification of rigid contact lenses.5
SIST EN ISO 8321-1:2002
ISO 8321-1:2002(E) iv © ISO 2002 – All rights reserved Foreword ISO (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 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, governmental and non-governmental, 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 8321 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8321-1 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 8321-1:1991), which has been technically revised to include requirements for refractive index, transmittance and oxygen permeability and transmissibility and to include reference to International Standards providing relevant test methods. ISO 8321 consists of the following parts, under the general title Ophthalmic optics — Specifications for material, optical and dimensional properties of contact lenses: =Part 1: Rigid corneal and scleral contact lenses =Part 2: Single-vision hydrogel contact lenses Annex A of this part of ISO 8321 is for information only. SIST EN ISO 8321-1:2002
INTERNATIONAL STANDARD ISO 8321-1:2002(E) © ISO 2002 – All rights reserved 1 Ophthalmic optics — Specifications for material, optical and dimensional properties of contact lenses — Part 1: Rigid corneal and scleral contact lenses 1 Scope This part of ISO 8321 specifies requirements for rigid corneal and scleral contact lenses including tolerance limits for material, optical and dimensional properties. A method for presenting the specification of contact lenses is described in annex A. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 8321. For dated references, subsequent amendments to, or revisions of, any of these publications
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