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I.S. EN ISO 13212:2014

I.S. EN ISO 13212:2014

Current

Current

The latest, up-to-date edition.

OPHTHALMIC OPTICS - CONTACT LENS CARE PRODUCTS - GUIDELINES FOR THE DETERMINATION OF SHELF-LIFE (ISO 13212:2014)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Gives guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.

DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
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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Hardcopy - English
PDF - English
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