UNI EN ISO 9394 : 2013
Current
The latest, up-to-date edition.
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
07-02-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Animals and husbandry
6 Reagents/materials
7 Apparatus
8 Test specimens
9 Test procedure
10 Assessment of results
11 Test report
Annex A (normative) - McDonald-Shadduck score
system - Slit lamp
Annex B (normative) - Draize scale for scoring
ocular lesions
Bibliography
Describes an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products.
| Committee |
CT 44
|
| DocumentType |
Test Method
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 9394:2012 | Identical |
| I.S. EN ISO 9394:2012 | Identical |
| NF EN ISO 9394 : 2012 | Identical |
| BS EN ISO 9394:2012 | Identical |
| NEN EN ISO 9394 : 2012 | Identical |
| NS EN ISO 9394 : 2012 | Identical |
| EN ISO 9394:2012 | Identical |
| DIN EN ISO 9394:2013-01 | Identical |
| ISO 9394:2012 | Identical |
| NBN EN ISO 9394 : 2012 | Identical |
| UNE-EN ISO 9394:2013 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 18369-1:2017 | Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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