BS ISO 19979:2018 pdf download – Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses
This document provides guidance to manufacturers for the development of information to be providedto 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 formultipatient use.
NOTE ISO 14729 does not cover multipatient use.
2Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references,only the edition cited applies. Forundated references, the latest edition of the referenced document (including any amendments) applies.ISO 18369-1，Ophthalmic optics —Contact lenses – Part 1: Vocabulary,classification system andrecommendations for labelling specifications
3 Terms and definitions
For the purposes of this document,the terms and definitions given in ISo 18369-1 andthe following apply.
IlS0 and IEC maintain terminological databases for use in standardization at the following addresses:一IEC Electropedia: available at http:// www.electropedia.org/
ISO online browsing platform: available at https:// www.iso.org/obp3.1
trial contact lens
diagnostic contact lens
contact lens only used by a practitioner or fitter for the purpose of selecting the appropriatecontact lens parameters for the intended wearer
[SOURCE: ISO 18369-1:2017,3.1.10.8]
3.2
multipatient use trial contact lens
trial contact lens permitted to be used on more than one person
[SOURCE: ISO 18369-1:2017,3.1.10.9, modified —Note 1 to entry has been deleted.]
3.3
competent personnel
personnel, qualified or trained for the hygienic conditioning of contact lenses3.4
composite contact lens
contact lens composed of two or more different materials
[SOURCE: ISO 18369-1:2017,3.1.1.11, modified —The example has been deleted.]
4 Methods of hygienic management for multipatient use trial contact lensesThe ideal approach for trial contact lenses is to use the lens a single time, after which the lens isdispensed to the same individual or discarded. Where reuse is necessary, moist heat management ispreferred over chemical management whenever applicable.
The manufacturer shall provide instructions for the hygienic management of multipatient use trialcontact lenses appropriate to the type of lens being used.
The instructions shall include advice on the process to be applied and on how to maintain the processedcontact lens in a suitable condition (e.g. container choice, container closure).
Ocular irritation due to use of a chemical disinfection method should be considered.
When using this document as guidance for the development of a hygienic management procedure formultipatient use, the disinfection performance shall be appropriate to meet at least the requirementsin Clause 5.
5 Options for hygienic management of multipatient use trial contact lenses
5.1General
Table 1 gives general information on relevant items for the hygienic management of multipatient usetrial contact lenses.
5.2 Disinfection procedure with moist heat
Table 2 gives guidance on factors to be considered for disinfection with moist heat.
NOTE Only after a properly validated sterilization process, according to ISO/TS 17665-2:2009, Table 1, can the lens be described as sterile.BS ISO 19979 pdf download.