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

The DIN EN ISO 15798:2001 standard, published by the German Institute for Standardization (DIN), provides comprehensive guidelines for ophthalmic viscosurgical devices (OVDs) used in eye surgery. These devices are crucial in maintaining the shape of the eye, protecting ocular tissues, and facilitating surgical procedures. The standard specifies the requirements for the physical, chemical, and biological properties of OVDs, ensuring their safety and efficacy in clinical use.

This standard is an adoption of the international standard ISO 15798:2001, which was developed to harmonize the quality and performance criteria for OVDs globally. It covers aspects such as viscosity, elasticity, and cohesiveness, which are critical for the proper functioning of these devices during ophthalmic surgeries like cataract extraction and intraocular lens implantation. Additionally, the standard outlines the necessary testing methods to evaluate the performance and safety of OVDs, including biocompatibility and sterility assessments.

By adhering to DIN EN ISO 15798:2001, manufacturers can ensure that their products meet the stringent requirements for ophthalmic surgical applications, thereby enhancing patient safety and surgical outcomes. The standard also serves as a reference for regulatory bodies and healthcare professionals to assess the quality of OVDs used in eye surgeries.