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BSI
BS EN ISO 9394:2012

BS EN ISO 9394:2012

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2012

Publisher

British Standards Institution

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.

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.

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

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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Hardcopy - English
PDF - English
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