ISO 11979-10:2018 PDF
Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 17
- Дата публикации:
- 23 марта 2018 г.
- Издание:
- ISO IS 11979 edition 2 version 1
- ICS:
- 11.040.70
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.
Abstract
Overview
ISO 11979-10:2018 - "Ophthalmic implants - Intraocular lenses - Part 10" defines clinical-investigation requirements for phakic intraocular lenses (phakic IOLs) implanted in the anterior segment to correct refractive errors (ametropia) while preserving the natural crystalline lens. The standard covers three optical categories: phakic monofocal (PIOL), phakic multifocal (PMIOL) and phakic toric (PTIOL), each of which can be intended for anterior- or posterior-chamber implantation. It provides specific clinical requirements that complement other parts of the ISO 11979 series.
Key topics and technical requirements
- Scope and device categories: Defines PIOL, PMIOL and PTIOL categories and their chamber designations.
- Clinical design guidance: Specifies when to use non-controlled versus controlled clinical investigations:
- Non-controlled investigations for PIOLs and higher-cylinder PTIOLs.
- Controlled investigations for PMIOLs and low-cylinder PTIOLs (≤ 1.5 D).
- Primary safety endpoint: Endothelial cell density is identified as the principal safety measure for phakic IOL studies.
- PTIOL-specific requirement: Rotational stability must be demonstrated; objective performance criteria are given (absolute rotation
Технические детали
- Технический комитет
- ISO/TC 172/SC 7 - Ophthalmic optics and instruments
- SKU
- ISO 11979-10:2018
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