ISO/TS 19979:2004
(Main)Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses
Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses
ISO/TS 19979:2004 provides guidance to contact lens manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial soft and rigid gas-permeable (RGP) contact lenses intended for multipatient use.
Optique ophtalmique — Lentilles de contact — Entretien de l'hygiène des lentilles de contact d'essai à usage multipatient
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Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 19979
First edition
2004-02-01
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/TS 19979:2004(E)
©
ISO 2004
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ISO/TS 19979:2004(E)
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ii © ISO 2004 – All rights reserved
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ISO/TS 19979:2004(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 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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
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/TS 19979 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
© ISO 2004 – All rights reserved iii
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ISO/TS 19979:2004(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 RGP
and soft contact lenses in special designs and parameters are necessary to meet individual patient needs.
The subject of transmission of diseases such as nvCJD via multipatient use of trial contact lenses has recently
become a topic of discussion. It is anticipated that the discussions will be ongoing for some time making it
impossible to reach agreement on an International Standard. Therefore, the working group decided that the
publication of a Technical Specification for the hygienic management of multipatient use trial contact lenses
would be appropriate at this time. However, this Technical Specification does not address the inactivation of
prions since there are no reported cases of transmission of prions by contact lenses. The user of this
Technical Specification should consult the scientific literature for any change in processes and procedures
that may result.
It is important that industry have available, a guideline in the form of a Technical Specification. If the standard
is followed, the risk of patient-to-patient transmission of an infectious micro-organism from trial contact lenses
may be reduced.
This Technical Specification is not to be regarded as an International Standard. Its proposed application is
provisional so that information and experience based on its use in practice may be gathered.
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TECHNICAL SPECIFICATION ISO/TS 19979:2004(E)
Ophthalmic optics — Contact lenses — Hygienic management
of multipatient use trial contact lenses
1 Scope
This Technical Specification provides guidance to contact lens manufacturers for the development of
information to be provided to eye care practitioners for the hygienic management of trial soft and rigid gas-
permeable (RGP) contact lenses intended for multipatient use.
See Annex A for an example of labelling information.
This Technical Specification does not address:
national regulations for labelling of contact lenses;
the inactivation of prions since there are no reported cases of transmission of prions by contact lenses.
NOTE This Technical Specification acknowledges that risk factors for possible transmission of specific diseases by
use of trial contact lenses on multiple patients may vary by country or other political or geographical barriers. Legal
requirements involving national practices or regulations take precedence over this Technical Specification.
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 14534:2002, Ophthalmic optics — Contact lenses and contact lens care products — Fundamental
requirements
3 Terms and definitions
For the purposes of this document the following terms and definitions apply.
3.1
trial contact lens
diagnostic contact lens
contact lens only used by a practitioner or fitter for the purpose of selecting the appropriate contact lens
parameters for the intended wearer
3.2
multipatient use trial contact lens
trial contact lens permitted to be used on more than one person
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ISO/TS 19979:2004(E)
4 Methods of hygienic management for multipatient use of trial contact lenses
4.1 General
The contact lens manufacturer’s instructions for the hygienic management of multipatient use trial contact
lenses should ensure that the performance criteria of methods of heat or chemical management are not
compromised by the instructions. Manufacturers of contact lenses and contact lens care products should
consider the issues that may arise when specifying a system for the hygienic management of multipatient use
trial contact lenses (e.g., incompatibilities between a specific contact lens, lens care system, chemical agents
and/or storage container).
4.2 Single use conditions
All trial contact lenses used with patients identified as potential carriers of infectious diseases such as CJD,
herpes simplex, hepatitis, HIV or adenovirus shall be disposed of after use. Any lens known to be infected
shall be discarded immediately to minimize contamination in practice. In this case, the use of disposable
gloves is necessary.
NOTE 1 If any country’s regulations require other infectious diseases to be added, these should apply in the
country/area concerned.
NOTE 2 Local regulations governing the disposal of biohazardous waste may apply.
4.3 Hand washing
Instructions should be given to wash the hands in accordance with the eye care professional’s
recommendations.
NOTE For those countries without an eye care profession’s recommendation on hand washing, see A.1.2 and A.1.3.
4.4 Adjunctive solutions
All solutions used in the hygienic management of contact lenses or contact lens containers shall meet the
requirements of ISO 14534. Water from the tap should not be used to hygienically manage the contact lens or
its container.
4.5 Use of a contact lens cleaner
The use of a cleaning and rinsing solution(s) shall be part of the procedure of reprocessing of multipatient use
trial contact lenses, as specified by the manufacturer. All multipatient use trial contact lenses should be
cleaned and rinsed just prior to use as well as after use.
4.6 Containers
The contact lens manufacturer should state the type of container suitable for the hygienic management of
multipatient use trial contact lenses. Consideration should be given to the recommendations of the
manufacturer of the contact lens care system. The methods should be stated by which the container can be
cleaned, properly closed and relabelled, if appropriate.
4.7 Frequency and lifetime of hygienic management of multipatient use trial contact lenses
The physical performance criteria for discontinuation of use should be gi
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