EN ISO 19979:2023
(Main)Ophthalmic optics - Contact lenses - Hygienic management of multipatient use trial contact lenses (ISO 19979:2018)
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 Anpasskontaktlinsen 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 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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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
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.
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
ISO 19979:2018(E)
© 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
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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 . 8
ISO 19979:2018(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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This first edition of ISO 19979:2018 cancels and replaces ISO/TS 19979:2014, which has been technically
revised. In addition to the change in document type from a Technical Specification to an International
Standard, the main changes compared to ISO/TS 19979:2014 are as follows:
— the specific processes of hygienic management have been presented as tables;
— a flow chart of the hygienic management process has been introduced;
— the example of disinfection procedure using hydrogen peroxide has been moved to Annex A;
— editorial revisions have been implemented.
iv © ISO 2018 – All rights reserved
ISO 19979:2018(E)
Introduction
Wherever possible, a trial contact lens should be used only on one individual. While the current trend in
contact lens development is toward disposable and extended wear lenses, conventional lenses including
rigid gas-permeable (RGP) contact lenses, composite contact lenses and hydrogel contact lenses in
special designs and parameters are necessary to meet individual patient needs.
The reconditioning of multipatient use contact lenses involves cleaning, disinfection and storage of the
contact lenses. The cleaning step is not specified in this document, as it does not differ from the cleaning
of contact lenses for end-users.
The hygienic management for multipatient use differs from the requirements of hygienic management
for contact lenses for individual use and from surface disinfection used in hospitals.
This document gives guidance for the development of instructions for manufacturers of multipatient
use contact lenses, in order to mitigate the risk of pathogen transfer between patients.
INTERNATIONAL STANDARD ISO 19979:2018(E)
Ophthalmic optics — Contact lenses — Hygienic
management of multipatient use trial contact lenses
1 Scope
This document 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.
This document does not apply to:
— labelling of contact lenses;
— the inactivation of prions and viruses since there are no standardised methods available for
contact lenses.
This document can be used as guidance for the development of a hygienic management procedure for
multipatient use.
NOTE ISO 14729 does not cover multipatient use.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and
recommendations for labelling specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
3.1
trial contact lens
diagno
...
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