ISO 13212:2014 PDF

Scope: 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.

ISO 13212:2014 Referenced Document

ISO 14534:2011 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
ISO 14729:2001 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14730:2000 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
ISO 18369-1:2006 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications

2014 ISO 13212:2014 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
2011 ISO 13212:2011 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
1999 ISO 13212:1999 Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life