BS ISO 19979:2018 pdf free
BS ISO 19979:2018 pdf free.Ophthalmic optics一Contact lenses一Hygienic management of multipatient use trial contact lenses
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:
一labelling of contact lenses;
一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.
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 一Contact lenses- Part 1: Vocabulary, cassification system and recommendations for labelling specifications
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:
一IEC Electropedia: available at http://www.electropedia.org/
一ISO Online browsing platform: available at https://www.iso.org/obp
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.BS ISO 19979 pdf download.
