BS 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
Hardcopy , PDF
English
31-10-2012
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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
Describes an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products.
| Committee |
CH/172/9
|
| DevelopmentNote |
Supersedes 97/560998 DC. (03/2005) Supersedes 11/30243462 DC. (10/2012)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.
| Standards | Relationship |
| SN EN ISO 9394:2012 | Identical |
| UNI EN ISO 9394 : 2013 | Identical |
| I.S. EN ISO 9394:2012 | Identical |
| NF 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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