Ophthalmics – Implantable Glaucoma Devices
|Publication Date:||27 January 2014|
Scope and purpose
The scope of this standard applies to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect depends upon metabolic and/or pharmacologic mechanisms.
The purpose of the standard is to describe the physical, mechanical and biocompatibility properties, as well as the elements of clinical protocols that may be useful in assessing the clinical performance of these devices.