BS ISO 19979:2018 pdf download

BS ISO 19979:2018 pdf download.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
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 18369-1:2017, 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.]
4 Methods of hygienic management for multipatient use trial contact lenses
The ideal approach for trial contact lenses is to use the lens a single time, after which the lens is dispensed to the same individual or discarded. Where reuse is necessary, moist heat management is preferred over chemical management whenever applicable. The manufacturer shall provide instructions for the hygienic management of multipatient use trial contact 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 processed contact 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 for multipatient use, the disinfection performance shall be appropriate to meet at least the requirements in Clause 5.