EN ISO 18369-1:2006
(Main)Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006)
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006)
ISO 18369-1:2006 identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. ISO 18369-1:2006 also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.
Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen für die Schreibweise von Kontaktlinsenspezifikationen (ISO 18369-1:2006)
Dieser Teil von ISO 18369 legt Begriffe für die physikalischen, chemischen und optischen Eigenschaften von Kontaktlinsen sowie deren Herstellung und Gebrauch fest. Er gibt hierzu die Begriffe und ihre Definitionen so¬wie, wo zutreffend, die international festgelegten Symbole und Kurzzeichen an. Dieser Teil von ISO 18369 legt weiterhin Begriffe für Kontaktlinsenpflegemittel fest. Darüber hinaus legt er ein System zur Einteilung von Kontakt¬linsen¬materialien fest, und er empfiehlt Schreibweisen für die Angabe von Kontaktlinsen¬spezifika¬tio¬nen.
Optique ophtalmique - Lentilles de contact - Partie 1: Vocabulaire, système de classification et recommandations pour l'étiquetage des spécifications (ISO 18369-1:2006)
L'ISO 18369-1:2006 définit les termes applicables aux propriétés physiques, chimiques et optiques des lentilles de contact, à leur fabrication et à leur utilisation. Elle fournit une liste de termes et, si nécessaire, le symbole et l'abréviation associés à un terme spécifique. L'ISO 18369-1:2006 définit également les termes relatifs aux produits d'entretien des lentilles de contact. Elle comporte en outre la classification des matériaux de lentilles de contact et donne les recommandations pour les spécifications d'étiquetage des lentilles de contact.
Očesna optika - Kontaktne leče - 1. del: Slovar, sistem razvrstitve in priporočila za označevanje specifikacij (ISO 18369-1:2006)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006)Optique ophtalmique - Lentilles de contact - Partie 1: Vocabulaire, systeme de classification et recommandations pour l'étiquetage des spécifications (ISO 18369-1:2006)Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen für die Schreibweise von Kontaktlinsenspezifikationen (ISO 18369-1:2006)Ta slovenski standard je istoveten z:EN ISO 18369-1:2006SIST EN ISO 18369-1:2006en,fr,de11.040.70Oftalmološka opremaOphthalmic equipment01.040.11Zdravstveno varstvo (Slovarji)Health care technology (Vocabularies)ICS:SIST EN ISO 8321-1:2002SIST EN ISO 8321-2:2000SIST EN ISO 8320-2:2002SIST EN ISO 11539:2001SIST EN ISO 8320-1:20031DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 18369-1:200601-december-2006
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 18369-1
August 2006 ICS 01.040.11; 11.040.70 Supersedes
EN ISO 8320-1:2003,
EN ISO 8320-2:2001and EN ISO 11539:1999, and partly supersedes EN ISO 8321-1:2002 andEN ISO 8321-2:2000English Version
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006)
Optique ophtalmique - Lentilles de contact - Partie 1: Vocabulaire, système de classification et recommandations pour l'étiquetage des spécifications (ISO 18369-1:2006)
Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen für die Schreibweise von Kontaktlinsenspezifikationen (ISO 18369-1:2006) This European Standard was approved by CEN on 19 May 2006.
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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
B-1050 Brussels © 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18369-1:2006: E
Foreword
This document (EN ISO 18369-1:2006) 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 February 2007, and conflicting national standards shall be withdrawn at the latest by February 2007.
This document supersedes EN ISO 8320-1:2003, EN ISO 8320-2:2001 and EN ISO 11539:1999 and partly supersedes EN ISO 8321-1:2002 and EN ISO 8321-2:2000.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 18369-1:2006 has been approved by CEN as EN ISO 18369-1:2006 without any modifications.
NOTE: A-Deviations are given in Annex ZA (informative)
3 ANNEX ZA
(informative) A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being outside the competence of the CEN/CENELEC member.
This European Standard does not fall under any Directive of the EC. In the relevant CEN/CENELEC countries these A-deviations are valid instead of the provisions of the European 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 on symbols and units and with the respective basic resolution of the CGPM (International Conference on Weights and Mesures).
Identification of the regulation:
Gesetz über die Einheiten im Messwesen vom 02.07.1969 in der Fassung der Bekanntmachung vom 22.04.1985;
and
Ausführungsverordnung zum Gesetz über Einheiten im Messwesen (Einheitenverordnung - EinhV) vom 13.12.1985, § 1 und Anlage 1, Nr. 9.
Reference numberISO 18369-1:2006(E)© ISO 2006
INTERNATIONAL STANDARD
ISO18369-1First edition2006-08-15Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications Optique ophtalmique — Lentilles de contact — Partie 1: Vocabulaire, système de classification et recommandations pour l'étiquetage des spécifications
ISO 18369-1:2006(E) ©
ISO 2006 The reproduction of the terms and definitions contained in this International Standard is permitted in teaching manuals, instruction booklets, technical publications and journals for strictly educational or implementation purposes. The conditions for such reproduction are: that no modifications are made to the terms and definitions; that such reproduction is not permitted for dictionaries or similar publications offered for sale; and that this International Standard is referenced as the source document. With the sole exceptions noted above, no other part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii
ISO 18369-1:2006(E) © ISO 2006 – All rights reserved
iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Terms, definitions and symbols.1 2.1 Terms and definitions.1 2.1.1 Basic terms.1 2.1.2 Contact lens parameters and design.3 2.1.3 Aspheric contact lenses.15 2.1.4 Bifocal and multifocal contact lenses.16 2.1.5 Scleral contact lenses and shells.18 2.1.6 Contact lens material properties.20 2.1.7 Tinted contact lenses.23 2.1.8 Contact lens manufacture.23 2.1.9 Packaging and labelling of contact lenses and contact lens care products.23 2.1.10 Contact lens usage and wear modality.25 2.1.11 Contact lens hygienic management and contact lens care products.26 2.1.12 Miscellaneous.29 2.2 Symbols.31 3 Classification of contact lens materials.32 Annex A (informative)
Specification of rigid contact lenses.35 Annex B (informative)
Specification of soft contact lenses.43 Bibliography.45 Alphabetical index.46
ISO 18369-1:2006(E) iv
ISO 18369-1:2006(E) © ISO 2006 – All rights reserved
vIntroduction The ISO 18369 series applies to contact lenses, which are devices worn over the front surface of the eye in contact with the preocular tear film. This part of ISO 18369 covers rigid (hard) corneal and scleral contact lenses, as well as soft contact lenses. Rigid lenses maintain their own shape unsupported and are made of transparent optical-grade plastics, such as polymethylmethacrylate (PMMA), cellulose acetate butyrate (CAB), polyacrylate/siloxane copolymers, rigid polysiloxanes (silicone resins), butylstyrenes, fluoropolymers, and fluorosiloxanes, etc. Soft contact lenses are easily deformable and require support for proper shape. A very large subset of soft contact lenses consists of transparent hydrogels containing water in concentrations greater than 10 %. Soft contact lenses can also be made of non-hydrogel materials, e.g. flexible polysiloxanes (silicone elastomers). The ISO 18369 series is applicable to determining allowable tolerances of parameters and properties important for proper functioning of contact lenses as optical devices. The ISO 18369 series includes tolerances for single vision contact lenses, bifocal lenses, lenses that alter the flux density and/or spectral composition of transmitted visible light (tinted or pigmented contact lenses, such as those with enhancing, handling, and/or opaque tints), and lenses that significantly attenuate ultraviolet radiation (UVR absorbing lenses). The ISO 18369 series covers contact lenses designed with spherical, toric, and aspheric surfaces, and recommended methods for the specification of contact lenses. The vocabulary portion (2.1) of this part of ISO 18369 contains the terms and definitions primarily used in the contact lens field. A list of terms having special sym
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