ISO 14730:2014 specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods to be used for determination of discard date as informative annexes.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Test methods
5.1 Materials and reagents
5.2 Test sampling and culture maintenance
5.3 Preparation of microbial challenge (Inoculum)
5.4 Inoculum challenge test procedure
5.5 Controls
5.6 Performance criteria
5.7 Test report
Annex A Example of a membrane filtration procedure II (informative)
Annex B Discard date procedure I (informative)
Annex C Discard date procedure (informative)
Annex D Discard date procedure III (informative)
Annex E Discard date procedure IV (informative)
Annex F Test organisms from other culture collections (informative)
ISO 14534:2011 Ophthalmic optics -- Contact lenses and contact lens care products -- Fundamental requirements
ISO 18369-1:2006 Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 14534:2011 Ophthalmic optics -- Contact lenses and contact lens care products -- Fundamental requirements
ISO 18369-1:2006 Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labelling specifications