EN ISO 13212:2014
Current
The latest, up-to-date edition.
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)
03-09-2014
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 |
| Standards | Relationship |
| BS EN ISO 13212:2014 | Identical |
| NEN EN ISO 13212 : 2014 | Identical |
| PN EN ISO 13212 : 2015 | Identical |
| SS-EN ISO 13212:2014 | Identical |
| NS EN ISO 13212 : 2014 | Identical |
| DIN EN ISO 13212:2014-12 | Identical |
| ISO 13212:2011 | Identical |
| NBN EN ISO 13212 : 2014 | Identical |
| NF EN ISO 13212 : 2014 | Identical |
| I.S. EN ISO 13212:2014 | Identical |
| UNE-EN ISO 13212:2014 | Identical |
| ISO 13212:2014 | Identical |
| 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 |