I.S. EN ISO 9394:2012
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 (ISO 9394:2012)
Hardcopy , PDF
English
01-01-2012
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Defines an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products.
| DocumentType |
Standard
|
| Pages |
27
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 9394:2012 | Identical |
| UNI EN ISO 9394 : 2013 | 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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