ISO 11979-10:2018

Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

Datum objavljivanja: 23. 3. 2018.

Опште информације

Trenutna faza: 90.93 Effective date: 5. 6. 2023.

Inicijator: ISO

Pripada: ISO/TC 172/SC 7

Vrsta: Međunarodni standard

ICS: 11.040.70

Jezik: engleski francuski

Kupovina

Status: Objavljen

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11979-10:2006

POVUČEN
ISO 11979-10:2006/Amd 1:2014

TRENUTNO

OBJAVLJEN
ISO 11979-10:2018
90.93 Odluka o potvrđivanju standarda
5. 6. 2023.

Nacionalna preuzimanja

SRPS EN ISO 11979-10:2018

ISS

Oftalmološki implantati – Intraokularna sočiva – Deo 10: Klinička istraživanja intraokularnih sočiva za korekciju ametropije u „phakic” očima

60.60 Standard objavljen

Z172 Saznaj više