SIST EN ISO 19979:2023

Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses (ISO 19979:2018)

ISO 19979:2018 provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid gas-permeable (RGP) contact lenses intended for multipatient use.
ISO 19979:2018 does not apply to:
-      labelling of contact lenses;
-      the inactivation of prions and viruses since there are no standardised methods available for contact lenses.
ISO 19979:2018 can be used as guidance for the development of a hygienic management procedure for multipatient use.
NOTE       ISO 14729 does not cover multipatient use.

Augenoptik - Kontaktlinsen - Hygienemanagement für Kontaktlinsen zur Anwendung bei mehreren Personen (ISO 19979:2018)

Dieses Dokument enthält eine Anleitung für Hersteller zur Erstellung von Informationen, die Kontaktlinsenanpasser für das Hygienemanagement von Hydrogel-, Verbund- und formstabilen gasdurchlässigen Kontaktlinsen (RGP) zur Verfügung gestellt werden müssen, die zur Anwendung bei mehreren Personen vorgesehen sind.
Dieses Dokument ist nicht anwendbar für:
   die Produktinformation von Kontaktlinsen;
   die Inaktivierung von Prionen und Viren, da keine genormten Verfahren für Kontaktlinsen zur Verfügung stehen.
Dieses Dokument kann als Anleitung für die Entwicklung eines Hygienemanagementverfahrens für die Anwendung bei mehreren Personen angewendet werden.
ANMERKUNG   ISO 14729 deckt die Anwendung durch mehrere Personen nicht ab.

Optique ophtalmique - Lentilles de contact - Entretien de l'hygiène des lentilles de contact d'essai à usage multipatient (ISO 19979:2018)

Le présent document fournit aux fabricants des recommandations pour le développement d’instructions à transmettre aux ophtalmologues pour l’entretien des lentilles de contact d’essai en hydrogel, composites et rigides et perméables au gaz (RPG) à usage multipatient.
Le présent document ne s’applique pas à:
—     l’étiquetage des lentilles de contact;
—     l’inactivation de prions et virus car il n’existe pas de méthodes normalisées pour les lentilles de contact.
Le présent document peut être utilisé comme document d’orientation pour le développement d’un mode opératoire d’entretien des lentilles de contact à usage multipatient.
NOTE            L’ISO 14729 ne couvre pas l’usage multipatient.

Očesna optika - Kontaktne leče - Postopki higienskega ravnanja pri poskusni uporabi kontaktnih leč pri več pacientih (ISO 19979:2018)

Standard ISO 19979:2018 podaja navodila proizvajalcem za pripravo informacij, ki jih je treba zagotoviti očesnim zdravnikom za higiensko ravnanje pri poskusni uporabi kontaktnih leč iz hidrogela, kompozitnih in trdih kontaktnih leč, ki prepuščajo pline (RGP), pri več pacientih.
Standard ISO 19979:2018 se ne uporablja za:
- označevanje kontaktnih leč;
- inaktivacijo prionov in virusov, ker ni standardiziranih metod za kontaktne leče.
Standard ISO 19979:2018 je mogoče uporabljati kot navodilo za razvoj postopka higienskega ravnanja za uporabo pri več pacientih.
OPOMBA: ISO 14729 ne obravnava uporabe pri več pacientih.

General Information

• Status: Published
• Public Enquiry End Date: 23-Apr-2023
• Publication Date: 20-Aug-2023
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 20-Jun-2023
• Due Date: 25-Aug-2023
• Completion Date: 21-Aug-2023
• Ref Project: EN ISO 19979:2023 - Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses (ISO 19979:2018)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 19979:2023
01-september-2023
Očesna optika - Kontaktne leče - Postopki higienskega ravnanja pri poskusni
uporabi kontaktnih leč pri več pacientih (ISO 19979:2018)
Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial
contact lenses (ISO 19979:2018)
Augenoptik - Kontaktlinsen - Hygienemanagement für Kontaktlinsen zur Anwendung bei
mehreren Personen (ISO 19979:2018)
Optique ophtalmique - Lentilles de contact - Entretien de l'hygiène des lentilles de
contact d'essai à usage multipatient (ISO 19979:2018)
Ta slovenski standard je istoveten z: EN ISO 19979:2023
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 19979:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19979:2023

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SIST EN ISO 19979:2023


EN ISO 19979
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2023
EUROPÄISCHE NORM
ICS 11.040.70
English Version

Ophthalmic optics - Contact lenses - Hygienic management
of multipatient use trial contact lenses (ISO 19979:2018)
Optique ophtalmique - Lentilles de contact - Entretien Augenoptik - Kontaktlinsen - Hygienemanagement für
de l'hygiène des lentilles de contact d'essai à usage Kontaktlinsen zur Anwendung bei mehreren Personen
multipatient (ISO 19979:2018) (ISO 19979:2018)
This European Standard was approved by CEN on 28 May 2023.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19979:2023 E
worldwide for CEN national Members.

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SIST EN ISO 19979:2023
EN ISO 19979:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 19979:2023
EN ISO 19979:2023 (E)
European foreword
The text of ISO 19979:2018 has been prepared by Technical Committee ISO/TC 172 "Optics and
photonics” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 19979:2023 by 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 December 2023, and conflicting national standards
shall be withdrawn at the latest by December 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 19979:2018 has been approved by CEN as EN ISO 19979:2023 without any modification.

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...

SLOVENSKI STANDARD
oSIST prEN ISO 19979:2023
01-april-2023
Očesna optika - Kontaktne leče - Postopki higienskega ravnanja pri poskusni
uporabi kontaktnih leč pri več pacientih (ISO 19979:2018)
Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial
contact lenses (ISO 19979:2018)
Augenoptik - Kontaktlinsen - Hygienemanagement für Kontaktlinsen zur Anwendung bei
mehreren Personen (ISO 19979:2018)
Optique ophtalmique - Lentilles de contact - Entretien de l'hygiène des lentilles de
contact d'essai à usage multipatient (ISO 19979:2018)
Ta slovenski standard je istoveten z: prEN ISO 19979
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 19979:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 19979:2023

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oSIST prEN ISO 19979:2023
INTERNATIONAL ISO
STANDARD 19979
First edition
2018-03
Ophthalmic optics — Contact lenses —
Hygienic management of multipatient
use trial contact lenses
Optique ophtalmique — Lentilles de contact — Entretien de l'hygiène
des lentilles de contact d'essai à usage multipatient
Reference number
ISO 19979:2018(E)
©
ISO 2018

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oSIST prEN ISO 19979:2023
ISO 19979:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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oSIST prEN ISO 19979:2023
ISO 19979:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Methods of hygienic management for multipatient use trial contact lenses .2
5 Options for hygienic management of multipatient use trial contact lenses .2
5.1 General . 2
5.2 Disinfection procedure with moist heat. 4
5.3 Disinfection procedures using an 3 % ophthalmic hydrogen peroxide for 3 h
or equivalent . 5
5.4 Storage of disinfected lenses . 5
6 Flowchart to describe the use of multipatient use trial contact lenses .5
Annex A (informative) Disinfection procedure using an 3 % ophthalmic hydrogen
peroxide solution . 7
Bibliography .
...