ISO 11979-5:2020
Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 27
- Дата публикации:
- 24 сентября 2020 г.
- Издание:
- ISO IS 11979 edition 3 version 1
- ICS:
- 11.040.70
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
Abstract
Overview
ISO 11979-5:2020 - "Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility" specifies requirements and guidance for the . It addresses material selection, processing conditions, physicochemical characterization, biological testing and guidance for an ocular implantation test. The standard is risk‑based and intended to support safe design, manufacture and regulatory compliance of IOLs.
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