EN ISO 14730:2014
(Main)Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
ISO 14730:2014 specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods to be used for determination of discard date as informative annexes.
Augenoptik - Kontaktlinsenpflegemittel - Konservierungsmittelbelastungstest und Anleitung zur Feststellung der Aufbrauchfrist (ISO 14730:2014)
Diese Internationale Norm legt ein Verfahren fest, welches zur Bewertung der Konservierungs-leistung aller konservierten Mehrdosis-Kontaktlinsenpflegemittel einzusetzen ist, und sie stellt in informativen Anhängen einen Leitfaden zu Verfahren zur Bestimmung der Aufbrauchfrist zur Verfügung.
Der Test gilt für Produkte mit einer Aufbrauchfrist von bis zu 28 Tagen.
Der Test gilt nicht für sterile Produkte, die in Einzeldosen zum einmaligen Gebrauch verpackt sind oder Mehrdosisbehälter, die aufgrund ihrer Konstruktion über eine physische Barriere gegen mikrobielle Verunreinigungen verfügen.
ANMERKUNG 1 Grundprinzipien des Tests dürfen auch dazu angewendet werden, eine längere Aufbrauchfrist als 28 Tage festzulegen. Siehe hierzu Anhänge B, C, D und E.
ANMERKUNG 2 Ein mehrfaches Animpfen, ein Animpfen mit einer mikrobiologischen Mischprobe, die Einbeziehung von Kontaktlinsen oder der Zusatz einer organischen Verunreinigung kann möglicherweise die antimikrobielle Wirkung eines bestimmten Produktes beeinflussen. Die Bewertung dieser Faktoren sowie die Prüfung eines erweiterten Spektrums von Mikroorganismen und das Testen von Proben aus angebrochenen Behältern können zwar bei der Entwicklung eines Kontaktlinsenpflegemittels wichtig sein, werden aber bei dieser Internationalen Norm nicht berücksichtigt.
Optique ophtalmique - Produits d'entretien des lentilles de contact - Essais de l'efficacité de conservation antimicrobienne et lignes directrices pour la détermination de la durée d'utilisation après première ouverture (ISO 14730:2014)
L'ISO 14730:2014 spécifie la méthode suivie pour évaluer l'activité de conservation antimicrobienne de tous les produits d'entretien des lentilles de contact conservés en emballages multi-doses et fournit des lignes directrices sur les méthodes à utiliser pour la détermination de la durée d'utilisation après première ouverture, en annexes informatives.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Preskušanje učinkovitosti antimikrobnih sredstev za konzerviranje in napotek za določanje datuma za zavrženje (ISO 14730:2014)
Ta mednarodni standard določa postopek, ki se uporablja za vrednotenje dejavnosti antimikrobnih sredstev za konzerviranje vseh konzerviranih izdelkov za vzdrževanje kontaktnih leč z več odmerki, ter zagotavlja napotek za metode za določanje datuma za zavrženje v obliki informativnih dodatkov. Ta preskus se uporablja za izdelke z datumom za zavrženje do vključno 28 dni. Preskus se ne uporablja za sterilne izdelke v posameznih odmerkih za enkratno uporabo ali vsebnikih z več odmerki s fizičnimi pregradami za mikrobno onesnaženje (npr. vsebniki za aerosole).
OPOMBA 1: Načela preskusa je mogoče uporabiti za podaljšanje datuma za zavrženje nad 28 dni. Glej dodatke B, C, D in E.
OPOMBA 2: Uporaba več ali mešanih mikrobnih izzivov in/ali vključitev kontaktnih leč ali druge organske obremenitve lahko vplivajo na navidezno antimikrobno dejavnost posameznega izdelka. Vrednotenje teh spremenljivk skupaj s preskušanjem v prisotnosti širšega spektra mikroorganizmov in preskušanjem vzorcev iz delno uporabljenih posod je mogoče koristno pri razvoju izdelka za vzdrževanje kontaktnih leč, vendar je zunaj področja uporabe tega mednarodnega standarda.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2015
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SIST EN ISO 14730:2001
SIST EN ISO 14730:2001/AC:2001
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Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy
testing and guidance on determining discard date (ISO 14730:2014)
Augenoptik - Kontaktlinsenpflegemittel - Konservierungsmittelbelastungstest und
Anleitung zur Feststellung der Aufbrauchfrist (ISO 14730:2014)
Optique ophtalmique - Produits d'entretien des lentilles de contact - Essais de l'efficacité
de conservation antimicrobienne et lignes directrices pour la détermination de la durée
d'utilisation après première ouverture (ISO 14730:2014)
Ta slovenski standard je istoveten z: EN ISO 14730:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 14730
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.70 Supersedes EN ISO 14730:2000
English Version
Ophthalmic optics - Contact lens care products - Antimicrobial
preservative efficacy testing and guidance on determining
discard date (ISO 14730:2014)
Optique ophtalmique - Produits d'entretien des lentilles de Augenoptik - Kontaktlinsenpflegemittel -
contact - Essais de l'efficacité de conservation Konservierungsmittelbelastungstest und Anleitung zur
antimicrobienne et lignes directrices pour la détermination Feststellung der Aufbrauchfrist (ISO 14730:2014)
de la durée d'utilisation après première ouverture (ISO
14730:2014)
This European Standard was approved by CEN on 23 July 2014.
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 CEN-CENELEC 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14730:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 14730:2014) 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
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.
This document supersedes EN ISO 14730:2000.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14730:2014 has been approved by CEN as EN ISO 14730:2014 without any modification.
INTERNATIONAL ISO
STANDARD 14730
Second edition
2014-10-01
Ophthalmic optics — Contact lens
care products — Antimicrobial
preservative efficacy testing and
guidance on determining discard date
Optique ophtalmique — Produits d’entretien des lentilles de contact
— Essais de l’efficacité de conservation antimicrobienne et lignes
directrices pour la détermination de la durée d’utilisation après
première ouverture
Reference number
ISO 14730:2014(E)
©
ISO 2014
ISO 14730:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
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Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO 14730:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Test methods . 2
5.1 Materials and reagents . 2
5.2 Test sampling and culture maintenance . 2
5.3 Preparation of microbial challenge (Inoculum) . 3
5.4 Inoculum challenge test procedure . 3
5.5 Controls . 5
5.6 Performance criteria . 5
5.7 Test report . 6
Annex A (informative) Example of a membrane filtration procedure II . 7
Annex B (informative) Discard date procedure I . 9
Annex C (informative) Discard date procedure .12
Annex D (informative) Discard date procedure III .16
Annex E (informative) Discard date procedure IV.19
Annex F (informative) Test organisms from other culture collections .22
Bibliography .23
ISO 14730:2014(E)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments in collaboration with the Technical Committee CEN/TC 170,
Ophthalmic optics.
This second edition cancels and replaces the first edition (ISO 14730:2000), of which it constitutes a
minor revision.
iv © ISO 2014 – All rights reserved
ISO 14730:2014(E)
Introduction
Contact lens care products (CLCP) are used with contact lenses. These products rinse, clean, disinfect,
store, wet, aid the comfort of, and condition contact lenses. Some products have one function, while
others are multifunctional.
Usually, products manufactured for use with hydrogel lenses may be used with rigid gas-permeable
(RGP) or poly (methyl methacrylate) (PMMA) lenses, but products specifically used for RGP or PMMA
contact lenses are not usually suitable for hydrogel lenses.
Most CLCPs are manufactured as solutions and are commonly packaged and sold in multidose containers.
Dry products are sold as tablets or granules and shall be dissolved in a suitable solvent immediately
prior to use.
If the contact lens care product solution does not have any antimicrobial activity itself, an antimicrobial
preservative can be added to the product to inhibit the growth of microorganisms that might be
introduced from repeated dispensing during use and subsequent storage. All antimicrobial agents
have the potential for toxicity to the user. For maximum protection to the user, the concentration of the
preservative should be such that it provides adequate preservative activity with minimum toxicity.
There are differences between ophthalmic preparations and contact lens care products and some
of these differences are significant in relation to preservative efficacy testing. Typically, ophthalmic
preparations are packaged in small-volume containers and are used for short periods on compromised
eyes. Contact lens care products are distributed in larger volume containers and are used with contact
lenses on a long term basis on healt
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