BS EN ISO 13212:2014
Current
The latest, up-to-date edition.
Ophthalmic optics. Contact lens care products. Guidelines for determination of shelf-life
Hardcopy , PDF
English
30-09-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| 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 |
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.
| 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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