ISO/TS 19979:2014
(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 19979:2014 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
Second edition
2014-09-01
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 19979:2014(E)
©
ISO 2014
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ISO/TS 19979:2014(E)
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ii © ISO 2014 – All rights reserved
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ISO/TS 19979:2014(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 of trial contact lenses .2
4.1 General . 2
4.2 Single-use conditions . 2
4.3 Hand washing . . 2
4.4 Adjunctive solutions . 2
4.5 Use of a contact lens cleaner . 2
4.6 Containers . 2
4.7 Frequency and lifetime of hygienic management of multipatient use trial contact lenses. 2
4.8 Options for hygienic management of multipatient use trial contact lenses . 3
4.9 Records . 3
Annex A (informative) Example of information to be supplied by the contact lens manufacturer —
Hygienic management of multipatient use trial contact lenses .4
Bibliography . 7
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ISO/TS 19979:2014(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO/TS 19979:2004), of which it constitutes
a minor revision.
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ISO/TS 19979:2014(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) and soft contact lenses in special designs and parameters are necessary to
meet individual patient needs.
The subject of transmission of diseases such as variant Creutzfeld-Jakob Disease (vCJD) 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, it was 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 has to consult the scientific literature
for any change in processes and procedures that might result.
It is important that the industry have an available guideline in the form of a Technical Specification.
If the guideline is followed, the risk of patient-to-patient transmission of an infectious microorganism
from trial contact lenses can 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 can be gathered.
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TECHNICAL SPECIFICATION ISO/TS 19979:2014(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; and
— 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 can 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 documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14534, 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
[SOURCE: ISO 18369-1:2006, 2.1.10.8]
3.2
multipatient use trial contact lens
trial contact lens permitted to be used on more than one person
[SOURCE: ISO 18369-1:2006, 2.1.10.8.1]
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ISO/TS 19979:2014(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 could 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, Human Immunodeficiency Virus (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 apply in the
country/area concerned.
NOTE 2 Local regulations governing the disposal of biohazardous waste can apply.
4.3 Hand washing
Instructions should
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