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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

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.


Dates of withdrawal of national standards are available from NSAI.

€28.00
Excluding VAT

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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