Overview

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 as the ocular tissue of the rabbit is traditionally particularly suitable to evaluate the irritant properties of materials which come in contact with ocular tissue. It is incumbent upon the investigator to conduct such evaluations using good scientific laboratory practices, complying with regulations related to animal welfare and the general principles for biological evaluation. The existence of this standard does not imply that rabbit-eye testing is a requirement in the determination of biocompatibility of contact lenses and contact lens care products, nor that this test is sufficient by itself to determine the biocompatibility of contact lenses and contact lens care products. Taking into consideration animal welfare requirements, it is recommended that this in vivo test be carried out after obtaining data of in vitro toxicological testing. Care should be taken when extrapolating the test results to the human eye. With respect to edition DIN EN ISO 9394:1998-11, the scope has been rendered more precise and is now limited to the ocular safety of both novel contact lens material and contact lens care products; furthermore, the requirement has been included that the study is to be performed in accordance with ISO/IEC 17025 and Good Laboratory Practice (GLP) (OECD, Principles of Good Laboratory Practice, No. 1); for the evaluation of contact lens care products it has been specified that testing is to be conducted with representative conventional and silicone hydrogel lenses; a detailed list of all information to be given in the test report has been included. This standard has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments" in collaboration with CEN/TC 170 "Ophthalmic optics" (both secretariats: DIN, Germany). The responsible committee at DIN is Working Committee NA 027-01-08 AA "Augenoptik" ("Ophthalmic optics"), Working Group "Kontaktlinsen" ("Contact lenses") at NAFuO.

Document: references other documents

Responsible national committee

NA 027-01-08-04 AK - Contact lenses  

Responsible european committee

CEN/TC 170 - Ophthalmic optics