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 |
UNE-EN ISO 13212:2014 | Identical |
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 |
SN EN ISO 13212 : 2014 | Identical |
NBN EN ISO 13212 : 2014 | Identical |
NF EN ISO 13212 : 2014 | Identical |
UNI EN ISO 13212 : 2014 | Identical |
I.S. 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 |
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