ISO 11979-7:2024 PDF
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 51
- Дата публикации:
- 12 января 2024 г.
- Издание:
- ISO IS 11979 edition 5 version 1
- ICS:
- 11.040.70
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
Abstract
Overview
ISO 11979-7:2024 - "Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia" specifies the particular requirements for clinical investigations of intraocular lenses (IOLs) implanted to correct . This fifth edition updates clinical testing guidance, clarifies lens-type definitions (including non‑accommodative IOLs) and aligns clinical methodologies across lens subtypes. It is intended for new IOL models and for modifications of existing models where risk analysis indicates clinical data are needed.
Похожие стандарты
Стандарты, упомянутые в описании