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.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Clause 7.4 (ethylene chlorohydrin limit) conflicts with an existing published final guidance. See guidance #2 below (MIGS). Clause 7. 4 (ethylene oxide limit) conflicts with another recognized standard. See reference #4 below (ISO 11979-8).