ISO 11979-8:2017 PDF
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 12 апреля 2017 г.
- Издание:
- ISO IS 11979 edition 3 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
ISO 11979-8:2017 is an international standard that defines the fundamental requirements for intended for surgical implantation in the anterior segment of the human eye. This standard excludes corneal implants and transplants, focusing specifically on ensuring safety, performance, and quality for all types of IOLs. Developed by ISO’s Technical Committee ISO/TC 172 under the subcommittee SC 7 on ophthalmic optics and instruments, this standard aligns with global medical device regulations and best practices.
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