ISO 9394:2012 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.

ISO 9394:2012 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

2012 ISO 9394:2012 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
1998 ISO 9394:1998 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Determination of Biocompatibilty by Ocular Study with Rabbit Eyes (Second Edition)
1994 ISO 9394:1994 Optics and optical instruments - Determination of biological compatibility of contact lens material - Testing of the contact lens system by ocular study with rabbit eyes