11/30243462 DC : 0

Superseded

BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES

Available format(s)

Hardcopy , PDF

Superseded date

31-10-2012

Language(s)

English

Publisher

British Standards Institution

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Status	Superseded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	BS EN ISO 9394:2012

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