Ophthalmic optics. Contact lens care products. Guidelines for determination of shelf-life

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-09-2014

Publisher

British Standards Institution

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.

This International Standard 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.

This International Standard does 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	CH/172/9
DevelopmentNote	Supersedes 95/563410 DC. (08/2004) Supersedes BS 7208-20(1999). (06/2011) Supersedes 13/30266987 DC. (09/2014)
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current
Supersedes	95/563410 DC : JAN 96 13/30266987 DC : 0 BS EN ISO 13212:2011 BS 7208-20(1999) : 1999

Standards	Relationship
UNE-EN ISO 13212:2014	Identical
NEN EN ISO 13212 : 2014	Identical
NS EN ISO 13212 : 2014	Identical
DIN EN ISO 13212:2014-12	Identical
SN EN ISO 13212 : 2014	Identical
ISO 13212:2014	Identical
NBN EN ISO 13212 : 2014	Identical
NF EN ISO 13212 : 2014	Identical
UNI EN ISO 13212 : 2014	Identical
EN ISO 13212:2014	Identical
I.S. EN 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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BS EN ISO 13212:2014

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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