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EN ISO 13212:2014

Current

Current

The latest, up-to-date edition.

Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)

Published date

03-09-2014

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Determination of finished-product stability
Annex A (informative) - Example of a stability testing
        plan for the finished contact lens care product
Bibliography

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.

Committee
CEN/TC 170
DevelopmentNote
Supersedes PREN ISO 13212. (09/2014)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

ISO 18369-1:2017 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 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14730:2014 Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date

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