Name: UNI EN ISO 9394 : 2013
Brand: UNI

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

Published date

02-07-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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	CT 44
DocumentType	Test Method
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 9394 : 1999

Standards	Relationship
SN EN ISO 9394:2012	Identical
I.S. EN ISO 9394:2012	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
DIN EN ISO 9394 E : 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