EN ISO 9394:2012 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contactlens material and contact lens care products. The test assesses the degree of irritation to the ocular tissueproduced by the device under test. The test method is described in application to rabbit eyes.
EN ISO 9394:2012 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 18369-1 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]
EN ISO 9394:2012 history
2012EN ISO 9394:2012 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
1998EN ISO 9394:1998 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Determination of Biocompatibility by Ocular Study Using Rabbit Eyes