标准编号：ISO 11979-10:2018
中文名称：眼内植入物 人工晶状体 第10部分：人工晶状体对眼内屈光不正的临床研究
英文名称：Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
发布日期：2018-03
标准范围
This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design:
a) Phakic monofocal (PIOL);
b) Phakic multifocal (PMIOL); and
c) Phakic toric (PTIOL).
Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.
The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.
This document addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.
立即下载标准文件