ISO 11981:2017 pdf download

ISO 11981:2017 pdf download.Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses
1 Scope
This document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.
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 18369-1:2017, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 18369-2, Ophthalmic optics — Contact lenses — Part 2: Tolerances
ISO 18369-3:2017, Ophthalmic optics — Contact lenses — Part 3: Measurement methods
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 cycle
sequence of events, following instructions for use or recommendations by the manufacturer of the contact lens care product, to occur between the time the contact lens is removed from the eye and before it is placed back into the eye
3.2 standard saline solution
specific phosphate buffered saline at a pH of 7,4 ± 0,1 and a nominal osmolarity of 310 ± 5 mOsm
Note 1 to entry: The provisions for formulation and preparation of standard saline solution are given in ISO 18369-3:2017, 4.9.
3.3 control solution
standard saline solution or appropriate justified alternative solution used to cycle contact lenses
Note 1 to entry: Control solutions are not required to comply with this document, but can be used to gain further information about the test.
4.1.2 Contact lenses shall be cycled in a manner which simulates the procedures given in the manufacturer’s instructions for use of the contact lens care product(s), and tested in volumes in accordance with the manufacturer’s instructions. During the cycles, temperature should be considered. Unless otherwise specified the temperature should be 20 °C to 25 °C. Volumes for soaking should be at least the amount used to fill a standard lens case used for the care product(s). NOTE Use of organic soil (0,1 ml per contact lens as per ISO 18259:2014, Annex A) or other specified artificial tear fluid can be considered for in-eye simulation. In evaluating product(s) being used during on-eye wear, justification of cycling parameters should be documented with regard to simulation of real world conditions.