DIN EN ISO 9394:2013 PDF

Scope: 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.

DIN EN ISO 9394:2013 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 18369-1 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications*， 2017-08-23 Update
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]*， 2017-11-01 Update

2013 DIN EN ISO 9394:2013 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012); German version EN ISO 9394:2012
1998 DIN EN ISO 9394:1998 Eye optics – contact lenses and contact lens care products – determination of biocompatibility through testing on rabbit eyes