ISO 13212:2011 pdf free.Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life.
The purpose of stability tests of contact lens care products is to obtain sufficient information to enable the manufacturer to establish an appropriate shelf-life and identify any unique storage conditions required to appear on the labelling for the product.
The quality of a contact lens care product is determined by its content of active ingredient(s), its purity and its physicochemical and microbiological properties. It is important to take into account the possible interaction of the container/closure with the contents.
The stability studies are intended to ascertain how the quality of a product varies as a function of time and under the influence of a variety of environmental factors.
On the basis of the information thus obtained, storage conditions are recommended which will guarantee the maintenance of the quality of the product, in relation to its safety, performance and acceptability, throughout the proposed shelf-life.
The design of the finished-product stability studies for a care product is based on the knowledge obtained from studies on the active ingredient(s) and from the development studies.
This International Standard provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.
This International Standard does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.
2 Normative references
The following referenced documents are indispensable for the application 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 14729, Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14730, Ophthalmic optics — Contact lens care products — Antimicrobial presetvative efficacy testing and guidance on determining discard date
ISO 18369-1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications