EN ISO 14730:2000
(Main)Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2000)
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2000)
Specification of minimum requirements in order to guarantee a minimum quality of use.
Augenpolitik - Kontaktlinsenpflegemittel - Konservierungsmittlebelastungstest und Anleitung zur Feststellung der Aufbrauchfrist (ISO/FDIS 14730:2000)
Diese Internationale Norm legt ein Verfahren fest, welches zur Bewertung der Konservierungsleistung aller konservierten Mehrdosis-Kontaktlinsenpflegemittel einzusetzen ist, und sie stellt in informativen Anhängen einen Leitfaden zur Verfahren zur Bestimmung der Aufbrauchfrist zur Verfügung. Der Test gilt für Produkte mit einer Aufbrauchfrist von bis zu 28 Tagen. Grundprinzipien des Tests dürfen auch dazu angewendet werden, eine längere Aufbrauchfrist als 28 Tage festzulegen. Siehe hierzu Anhänge B, C, D und E.
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/FDIS 14730:2000)
La présente Norme internationale spécifie une méthode à suivre 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. Le présent essai est applicable pour une durée d'utilisation après première ouverture allant jusqu'à 28 jours. L'essai ne s'applique pas aux produits stériles emballés en doses unitaires destinées à un usage unique ni aux emballages multi-doses constituant des barrières physiques à la contamination microbienne (exemple : emballages aérosol).
NOTE 1: Les principes de l'essai peuvent être utilisés pour étendre la durée d'utilisation au-delà de 28 jours. Voir les annexes B, C, D et E.
NOTE 2: L'usage d'inoculums multiples ou mixtes et/ou l'inclusion de lentilles de contact ou d'autres charges organiques peut modifier l'activité antimicrobienne apparente d'un produit particulier. L'évaluation de ces variables, associée à l'essai sur une large gamme de micro-organismes et l'essai d'échantillons provenant de doses utilisées partiellement peuvent être intéressants pour développer un produit d'entretien des lentilles de contact, mais ne font pas partie du domaine d'application de la présente Norme internationale.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Preskušanje učinkovitosti antimikrobnih sredstev za konzerviranje in napotek za določanje datuma za zavrženje(ISO 14730:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2001
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Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy
testing and guidance on determining discard date (ISO 14730:2000)
Augenpolitik - Kontaktlinsenpflegemittel - Konservierungsmittlebelastungstest und
Anleitung zur Feststellung der Aufbrauchfrist (ISO/FDIS 14730:2000)
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 apres premiere ouverture (ISO/FDIS 14730:2000)
Ta slovenski standard je istoveten z: EN ISO 14730:2000
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
September 2000
ICS 11.040.70
English version
Ophthalmic optics - Contact lens care products - Antimicrobial
preservative efficacy testing and guidance on determining
discard date (ISO 14730:2000)
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 14730:2000)
de la durée d'utilisation après première ouverture (ISO
14730:2000)
This European Standard was approved by CEN on 15 September 2000.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2000 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14730:2000 E
worldwide for CEN national Members.
Page 2
Foreword
Corrected 2001-04-11
The text of the International Standard ISO 14730:2000 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 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 March 2001, and conflicting national
standards shall be withdrawn at the latest by March 2001.
Annexes A to F of this Standard are for information only.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the International Standard ISO 14730:2000 was approved by CEN as a European
Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).
Page 3
Annex ZA (normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 14534 1997 Ophthalmic optics - Contact lenses EN ISO 14534 1997
and contact lens care products -
Fundamental requirements
INTERNATIONAL ISO
STANDARD 14730
First edition
2000-09-15
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 14730:2000(E)
©
ISO 2000
ISO 14730:2000(E)
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ii © ISO 2000 – All rights reserved
ISO 14730:2000(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 .3
5.3 Preparation of microbial challenge (Inoculum) .3
5.4 Inoculum challenge test procedure .4
5.5 Controls .5
5.6 Performance criteria.5
5.7 Test report .6
Annex A (informative) Example of a membrane filtration procedure .7
Annex B (informative) Discard date procedure I.9
Annex C (informative) Discard date procedure II.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 14730:2000(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 14730 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
Annexes A to F of this International Standard are for information only.
iv © ISO 2000 – All rights reserved
ISO 14730:2000(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, whilst 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 must 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
may be added to the product to inhibit the growth of microorganisms that may 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 for use 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
healthy eyes. The potential risks for contact lens care products are the solution/lens interaction causing ocular
irritation and the risks of the solution contamination by the repeated (daily) use of the product.
Thus when contact lens care products are formulated, the risk of adverse patient reaction due to the lens and/or
solution interaction has to be weighed against the benefits of safety derived from the maintenance of the
antimicrobial activity of the solution.
This International Standard gives the test procedure and performance criteria for preservative efficacy. It has been
adapted from Pharmacopoeias which give a time limitation in their test procedure of 28
...
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