Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ANSI Z80.13:2007
• Năm ban hành / Publication date: 2007
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Ophthalmics – Phakic Intraocular Lenses
• Số trang / Page: 44

Phạm vi áp dụng / Scope of standard

Scope and purpose

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

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.