SIST EN ISO 11986:2011
(Main)Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2010)
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2010)
This International Standard provides general procedures for the selection of methods, preparation of samples, and conduct of testing for the uptake and release of preservatives from contact lenses.
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2010)
Diese Internationale Norm legt die allgemeine Vorgehensweise für die Auswahl von Prüfverfahren, die
Vorbereitung von Prüfmustern und die Durchführung von Prüfungen der Aufnahme und Wiederfreisetzung von
Konservierungsmitteln durch Kontaktlinsen fest.
ANMERKUNG 1 Aufgrund der offenkundigen Schwierigkeit, Kontaktlinsen in reproduzierbarer Weise mit mineralischen
und organischen Ablagerungen, die beim Kontaktlinsentragen auftreten können, zu versehen, gelten diese Verfahren nur
für neue und nicht benutzte Kontaktlinsen.
ANMERKUNG 2 Eine übermäßige Aufnahme des Konservierungsmittels aus dem begrenzten Volumen eines Kontaktlinsenbehälters
durch eine Kontaktlinse könnte sich negativ auf die Desinfektionsleistung auswirken. Diese Internationale
Norm behandelt nicht die Messung der Desinfektionsleistung.
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO 11986:2010)
L'ISO 11986:2010 fournit des modes opératoires généraux pour sélectionner les différentes méthodes, pour préparer les échantillons et pour réaliser des essais pour l'absorption/adsorption et le relargage des conservateurs par les lentilles de contact.
Očesna optika - Kontaktne leče in izdelki za vzdrževanje leč - Določanje privzema in sprostitve sredstva za konzerviranje (ISO 11986:2010)
Ta mednarodni standard podaja splošne postopke za izbiro metod, pripravo vzorcev in izvedbo preskušanja za privzem in sprostitev sredstva za konzerviranje iz kontaktnih leč.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2010)Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO 11986:2010)Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2010)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 11986:2010SIST EN ISO 11986:2011en01-januar-2011SIST EN ISO 11986:2011SLOVENSKI
STANDARDSIST EN ISO 11986:20001DGRPHãþD
SIST EN ISO 11986:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 11986
November 2010 ICS 11.040.70 Supersedes EN ISO 11986:2000English Version
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2010)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact - Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO 11986:2010)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2010) This European Standard was approved by CEN on 31 October 2010.
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, 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:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11986:2010: ESIST EN ISO 11986:2011
EN ISO 11986:2010 (E) 2 Contents Page Foreword .3 SIST EN ISO 11986:2011
EN ISO 11986:2010 (E) 3 Foreword This document (EN ISO 11986:2010) 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 May 2011, and conflicting national standards shall be withdrawn at the latest by May 2011. 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 11986:2000. 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, 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 11986:2010 has been approved by CEN as a EN ISO 11986:2010 without any modification.
SIST EN ISO 11986:2011
SIST EN ISO 11986:2011
Reference numberISO 11986:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO11986Second edition2010-11-01Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release Optique ophtalmique — Lentilles de contact et produits d'entretien pour lentilles de contact — Détermination de l'absorption/adsorption et du relargage des conservateurs
SIST EN ISO 11986:2011
ISO 11986:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO 11986:2011
ISO 11986:2010(E) © ISO 2010 – All rights reserved iii 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 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 11986 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 11986:1999), which has been technically revised. SIST EN ISO 11986:2011
ISO 11986:2010(E) iv © ISO 2010 – All rights reserved Introduction Contact lens care products are a complex mixture of organic and inorganic substances. For reasons of microbiological safety, contact lens disinfecting solutions, as well as care products in multi-use containers, contain substances with antimicrobial activity. From many years of experience in contact lens wear, it is known that irritation and sensitization problems sometimes occur due to these preservatives being absorbed and released by the matrix of the contact lens. For these reasons, it is necessary to be able to estimate the extent of preservative uptake and release by contact lenses. The preservative uptake and release test provides a general method for measuring the uptake of preservatives in solution by contact lenses and the release of preservatives from contact lenses in an aqueous medium. The analytical method to be used for quantification of specific preservatives is not indicated here. Chemical characteristics of the preservative, as well as concentration in the contact lens care product and degree of uptake by the contact lens, must be taken into consideration in selecting an appropriate analytical method. Contact lens uptake and release data may be useful in characterizing the potential for a new or modified contact lens material to produce a toxic or irritating reaction in the eye from the uptake and binding or release of preservatives from currently marketed contact lens care products.
SIST EN ISO 11986:2011
INTERNATIONAL STANDARD ISO 11986:2010(E) © ISO 2010 – All rights reserved 1 Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release 1 Scope This International Standard provides general procedures for the selection of methods, preparation of samples, and conduct of testing for the uptake and release of preservatives from contact lenses. NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses. NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This International Standard does not measure disinfection performance. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 18369-3:2006, Ophthalmic optics — Contact lenses — Part 3: Measurement methods 3 Principle The contact lenses to be tested are immersed in the test product at 25 °C ± 2 °C and the preservative content analysed at regular intervals of time un
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