Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ANSI Z80.27:2014
• Năm ban hành / Publication date: 2014
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Ophthalmics – Implantable Glaucoma Devices
• Thay thế cho / Replace: ANSI Z80.27:2001
• Số trang / Page: 49

Phạm vi áp dụng / Scope of standard

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.