Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ANSI Z80.30:2018
• Năm ban hành / Publication date: 2018
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Ophthalmics – Toric Intraocular Lenses
• Thay thế cho / Replace: ANSI Z80.30:2010
• Số trang / Page: 38

Phạm vi áp dụng / Scope of standard

Scope and purpose

This standard applies to any monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia.

This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As applies to any standard, alternative validated test methods may be used.