ISO 11980:2012
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 26
- Дата публикации:
- 14 ноября 2012 г.
- Издание:
- ISO IS 11980 edition 3 version 1
- ICS:
- 11.040.70
ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.
Abstract
Overview
ISO 11980:2012 - "Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations" provides international guidance for planning, conducting and reporting clinical investigations (CIs) that assess the of contact lenses and contact lens care products. The standard aligns CI requirements with good clinical practice (referencing ) and aims to harmonize regulatory expectations worldwide for pre‑market and post‑market studies.
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