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

Standard No.
EN ISO 13212:2014
Release Date
2014
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 13212:2014
Replace
FprEN ISO 13212:2014
Scope
This International Standard provides guidance for the design of stability studies with the aim of gathering information to determine the shelf life of contact lens care products. It does not apply to studies designed to obtain information on the stability of contact lens care products during use [ie information regarding discard date].

EN ISO 13212:2014 Referenced Document

  • 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 14730:2000 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

EN ISO 13212:2014 history

  • 2014 EN ISO 13212:2014 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)
  • 2011 EN ISO 13212:2011 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
  • 1999 EN ISO 13212:1999 (FAULTY STANDARD) Ophthalmic Optics - Contact Lens Care Products - Guidelines for the Determination of Shelf-Life



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