SIST 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:
- 16 августа 2017 г.
- ICS:
- 11.040.70
- Технический комитет:
- VAZ - Healthcare
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 - "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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