EN ISO 11986:2017

Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2017)

ISO 11986:2017 provides general procedures for the selection of methods, preparation of samples, and the 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 document does not measure disinfection performance.

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2017)

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 Kontakt¬linsen¬behälters 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 11986:2017)

ISO 11986:2017 fournit des modes opératoires généraux pour sélectionner les différentes méthodes, préparer les échantillons et réaliser des essais portant sur l'absorption/adsorption et le relargage des conservateurs par les lentilles de contact.
NOTE 1    En raison des difficultés évidentes rencontrées pour obtenir de façon reproductible des dépôts minéraux et organiques à la surface des lentilles de contact en cours de port, les présentes méthodes s'appliquent uniquement aux lentilles de contact neuves n'ayant jamais été utilisées.
NOTE 2    L'appauvrissement en conservateurs pour une lentille de contact placée dans le volume limité d'un étui à lentilles pourrait altérer les performances de décontamination. Le présent document ne mesure pas les performances de décontamination.

Očesna optika - Kontaktne leče in izdelki za vzdrževanje leč - Določanje privzema in sprostitve sredstva za konzerviranje (ISO 11986:2017)

Ta dokument določa splošne postopke za izbiro metod, pripravo vzorcev in
izvajanje preskusov za prevzem in sproščanje zaščitnih sredstev iz kontaktnih leč.
OPOMBA 1: Zaradi očitnih težav s ponovljivostjo pri nanašanju mineralnih in organskih nanosov na kontaktne leče med njihovo obrabo se te metode uporabljajo samo za nove in neuporabljene kontaktne leče.
OPOMBA 2: Zmanjšanje količine zaščitnih sredstev zaradi kontaktne leče v omejenem prostoru škatlice za leče lahko ogrozi učinkovitost razkuževanja. Ta dokument ne obravnava merjenja učinkovitosti razkuževanja.

General Information

• Status: Published
• Publication Date: 19-Dec-2017
• Withdrawal Date: 29-Jun-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Dec-2017
• Completion Date: 20-Dec-2017
• Ref Project: SIST EN ISO 11986:2018 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2017)

Relations

• Replaces: EN ISO 11986:2010 - Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2010)
• Effective Date: 27-Dec-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11986:2018
01-februar-2018
1DGRPHãþD
SIST EN ISO 11986:2011
2þHVQDRSWLND.RQWDNWQHOHþHLQL]GHONL]DY]GUåHYDQMHOHþ'RORþDQMHSULY]HPD
LQVSURVWLWYHVUHGVWYD]DNRQ]HUYLUDQMH,62
Ophthalmic optics - Contact lenses and contact lens care products - Determination of
preservative uptake and release (ISO 11986:2017)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Aufnahme
und Wiederfreisetzung von Konservierungsmitteln (ISO 11986:2017)
Optique ophtalmique - Lentilles de contact et produits d'entretien pour lentilles de contact
- Détermination de l'absorption/adsorption et du relargage des conservateurs (ISO
11986:2017)
Ta slovenski standard je istoveten z: EN ISO 11986:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11986:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11986:2018

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SIST EN ISO 11986:2018


EN ISO 11986
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11986:2010
English Version

Ophthalmic optics - Contact lenses and contact lens care
products - Determination of preservative uptake and
release (ISO 11986:2017)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und
d'entretien pour lentilles de contact - Détermination de Kontaktlinsenpflegemittel - Bestimmung der Aufnahme
l'absorption/adsorption et du relargage des und Wiederfreisetzung von Konservierungsmitteln
conservateurs (ISO 11986:2017) (ISO 11986:2017)
This European Standard was approved by CEN on 21 November 2017.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11986:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11986:2018
EN ISO 11986:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11986:2018
EN ISO 11986:2017 (E)
European foreword
This document (EN ISO 11986:2017) 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 June 2018, and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11986:2010.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11986:2017 has been approved by CEN as EN ISO 11986:20
...