EN ISO 18369-2:2006

Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2006)

ISO 18369-2:2006 specifies the tolerance limits of the principal optical and physical parameters of rigid, soft, and rigid scleral contact lenses.

Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2006)

Dieser Teil von ISO 18369 legt die Grenzabmaße bzw. Grenzabweichungen für die optischen und physika¬li¬schen Eigenschaften von formstabilen und weichen Kontaktlinsen und von formstabilen Skleralkontaktlinsen fest.

Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2006)

L'ISO 18369-2:2006 spécifie les limites de tolérance des principaux paramètres optiques et physiques des lentilles de contact rigides, souples et sclérales rigides.

Očesna optika - Kontaktne leče - 2. del: Tolerance (ISO 18369-2:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-2006
• Withdrawal Date: 30-Nov-2012
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Dec-2012
• Completion Date: 01-Dec-2012
• Ref Project: SIST EN ISO 18369-2:2006 - Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2006)

Relations

• Replaces: EN 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)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 8321-2:2000 - Ophthalmic optics - Specifications for materials, optical and dimensional properties of contact lenses - Part 2: Single-vision hydrogel lenses (ISO 8321-2:2000)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 18369-2:2012 - Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012)
• Effective Date: 08-Jun-2022
• Amended By: EN ISO 18369-2:2006/prA1 - Ophthalmic optics - Contact lenses - Part 2: Tolerances - Amendment 1 (ISO 18369-2:2006/DAM 1:2009)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2006)Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2006)Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2006)Ta slovenski standard je istoveten z:EN ISO 18369-2:2006SIST EN ISO 18369-2:2006en,fr,de11.040.70Oftalmološka opremaOphthalmic equipmentICS:SIST EN ISO 8321-2:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 18369-2:200601-december-2006

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 18369-2
August 2006 ICS 11.040.70 Partly supersedes EN ISO 8321-1:2002and EN ISO 8321-2:2000 English Version
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2006)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2006)
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2006) This European Standard was approved by CEN on 20 April 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 18369-2:2006: E

Foreword
This document (EN ISO 18369-2:2006) 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 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 18369-2:2006 has been approved by CEN as EN ISO 18369-2:2006 without any modifications.
NOTE A-Deviations are given in Annex ZA (informative).

EN ISO 18369-2 :2006 (E)
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 18369-2:2006(E)© ISO 2006
INTERNATIONAL STANDARD ISO18369-2First edition2006-08-15Ophthalmic optics — Contact lenses — Part 2: Tolerances Optique ophtalmique — Lentilles de contact — Partie 2: Tolérances

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ii © ISO 2006 – All rights reserved

ISO 18369-2:2006(E) © ISO 2006 – All rights reserved iiiForeword 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 2. 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18369-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. ISO 18369-2, together with ISO 18369-1, cancels and replaces ISO 8321-1:2002 and ISO 8321-2:2000, which have been technically revised. ISO 18369 consists of the following parts, under the general title Ophthalmic optics — Contact lenses: — Part 1: Vocabulary, classification system and recommandations for labelling specifications — Part 2: Tolerances — Part 3: Measurement methods — Part 4: Physicochemical properties of contact lens materials

ISO 18369-2:2006(E) iv © ISO 2006 – All rights reserved Introduction 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 (UV-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.

INTERNATIONAL STANDARD ISO 18369-2:2006(E) © ISO 2006 – All rights r
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