Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
眼科植入物 - 人工晶状体 - 第10部分:晶状体眼人工晶状体矫正屈光不正的临床研究
发布日期:
2018-03-23
ISO 11979-10:2018规定了任何人工晶状体植入眼前段的要求,其主要适应症是改变屈光力。
根据光学设计,有晶状体眼人工晶状体主要分为三类:
a) Phakic单焦点(PIOL);
b) 有晶状体多焦(PMIOL);和
c) 有晶状体复曲面(PTIOL)。
这些类别中的每一种都被进一步指定用于植入眼前节的前房或后房。
有晶状体人工晶状体的基本要求适用于所有类型。其他要求适用于PMIOL和PTIOL设计。
ISO 11979-10:2018阐述了ISO 11979其他部分未提及的有晶状体人工晶体的具体临床要求。
ISO 11979-10:2018 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.
ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.