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S WEDI S H STA NDARDS

I NST I T U TE

SVENSK STANDARD

SS-EN ISO 18369-1:2006/A1:2009

Faststlld/Approved: 2009-03-02 Publicerad/Published: 2009-03-26 Utgva/Edition: 1

Sprk/Language: engelska/English ICS: 01.040.11; 11.040.70

gonoptik – Kontaktlinser –

Del 1: Ordlista, klassifikationssystem och rekommendationer fr mrkning av specifikationer – Tillgg 1

(ISO 18369-1:2006/Amd 1:2009)

Ophthalmic optics – Contact lenses –

Part 1: Vocabulary, classification system and recommendations for labelling specifications – Amendment 1 (ISO 18369-1:2006/Amd 1:2009)

This preview is downloaded from www.sis.se. Buy the entire This preview is downloaded from www.sis.se. Buy the entire This preview is downloaded from www.sis.se. Buy the entire This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-69008

standard via https://www.sis.se/std-69008 standard via https://www.sis.se/std-69008 standard via https://www.sis.se/std-69008

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Upplysningar om sakinnehllet i standarden lmnas av SIS, Swedish Standards Institute, telefon 08-555 520 00.

Standarder kan bestllas hos SIS Frlag AB som ven lmnar allmnna upplysningar om svensk och utlndsk standard.

Information about the content of the standard is available from the Swedish Standards Institute (SIS), tel +46 8 555 520 00.

Standards may be ordered from SIS Frlag AB, who can also provide general information about Swedish and foreign standards.

SIS Frlag AB, SE 118 80 Stockholm, Sweden. Tel: +46 8 555 523 10. Fax: +46 8 555 523 11.

E-mail: [email protected] Internet: www.sis.se

Copyright/Upphovsrtten till denna produkt tillhr SIS, Swedish Standards Institute, Stockholm, Sverige. Anvndningen av denna produkt regleras av slutanvndarlicensen som ternns i denna produkt, se standardens sista sidor.

Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will nd the licence in the end of this document.

!

Europastandarden EN ISO 18369-1:2006/A1:2009 g ller som svensk standard. Detta dokument inneh ller den officiella engelska versionen av EN ISO 18369-1:2006/A1:2009.

The European Standard EN ISO 18369-1:2006/A1:2009 has the status of a Swedish Standard. This document contains the official English version of EN ISO 18369-1:2006/A1:2009.

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-69008

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EUROPEAN STANDARD NORME EUROP ENNE EUROP ISCHE NORM

EN ISO 18369-1:2006/A1

February 2009

ICS 01.040.11; 11.040.70

English Version

Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications - Amendment 1 (ISO 18369-1:2006/Amd 1:2009)

Optique ophtalmique - Lentilles de contact - Partie 1:

Vocabulaire, systme de classification et recommandations pour l'tiquetage des spcifications - Amendement 1 (ISO

18369-1:2006/Amd 1:2009)

Augenoptik - Kontaktlinsen - Teil 1: Begriffe, Einteilung von Kontaktlinsenmaterialien und Empfehlungen fr die Schreibweise von Kontaktlinsenspezifikationen - nderung

1 (ISO 18369-1:2006/Amd 1:2009)

This amendment A1 modifies the European Standard EN ISO 18369-1:2006; it was approved by CEN on 28 January 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.

This amendment 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 Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 C O M I T E U R O P  E N D E N O R M A L I S A T I O N E U R O P I S C H E S K O M I T E E F  R N O R M U N G

Management Centre: Avenue Marnix 17, B-1000 Brussels

 2009 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/A1:2009 E This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-69008

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Foreword

This Amendment (EN ISO 18369-1:2006/A1:2009) 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 Amendment to the European Standard EN ISO 18369:2006 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2009, and conflicting national standards shall be withdrawn at the latest by August 2009.

Attention is 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.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, 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 the United Kingdom.

Endorsement notice

The text of ISO 18369-1:2006/Amd 1:2009 has been approved by CEN as a EN ISO 18369-1:2006/A1:2009 without any modification.

SS-EN ISO 18369-1:2006/A1:2009 (E)

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-69008

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ISO 18369-1:2006/Amd.1:2009(E)

 ISO 2009 – All rights reserved

1

Ophthalmic optics — Contact lenses — Part 1:

Vocabulary, classification system and recommendations for labelling specifications

AMENDMENT 1

Page 32, Table 2

Add the following table row and its associated table footnote:

Group

suffix Hydrogel material Description

V Enhanced oxygen permeable materials a (e.g. silicone hydrogel)

Materials having an oxygen permeability (Dk) greater than 30Dk units as defined in 4.4 of ISO 18369-4:2006 (using hPa1) and that have aDk greater than that expected on the basis of the materials' water content alone

a It is expected that this classification will be further subdivided as more information is gained about the materials in this category.

SS-EN ISO 18369-1:2006/A1:2009 (E)

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-69008

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Anteckningar/Notes:

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-69008

References

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