Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); English version of DIN EN ISO 15798

This standard provides specifications for medical devices used in ophthalmic surgery, specifically focusing on viscoelastic substances and instruments designed for intraocular applications. It outlines requirements related to material composition, performance, and safety to ensure the suitability of these devices for clinical use. The standard includes testing procedures and criteria to verify compliance with established safety and efficacy benchmarks. It also addresses packaging, labeling, and storage conditions to maintain product integrity throughout the supply chain. The document is intended for manufacturers, regulators, and healthcare professionals involved in the development, evaluation, and use of such medical devices.