ISO 13212:2011 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. ISO 13212:2011does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Determination of finished-product stability
5.1 Objective
5.2 Study methods
5.3 Description of the product under study
5.4 Characteristics
5.5 Evaluation methods
5.6 Presentation of results
5.7 Discussion, interpretation and conclusions
5.8 Ongoing stability
Annex A Example of a stability testing plan for the finished contact lens care product (informative)
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
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