EN ISO 11979-8:2017 PDF
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 10 мая 2017 г.
- Издание:
- CEN EN 11979 edition 2 version 1
- ICS:
- 11.040.70
ISO 11979-8:2017 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.
Abstract
Overview
EN ISO 11979-8:2017 - "Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements" defines the fundamental safety and performance expectations for intended for surgical implantation into the anterior segment of the human eye. It applies across IOL types but explicitly . This harmonized European standard (CEN endorsement of ) supports regulatory conformity in the EU and is part of the wider for ophthalmic implants.
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