11/30243462 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
Hardcopy , PDF
10-31-2012
English
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Foreword
Introduction
1 Scope
2 Normative references
3 General requirements
4 Animals and husbandry
5 Reagents/Materials
6 Apparatus
7 Test specimens
8 Test procedure
9 Assessment of results
10 Test report
Annex A (normative) - McDonald-Shadduck score
system - Slit lamp
Annex B (normative) - Draize scale for scoring
ocular lesions
Bibliography
BS EN ISO 9394
| Committee |
CH/172/9
|
| DocumentType |
Draft
|
| Pages |
21
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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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