ISO 11980:2025
ISO 11980:2025 Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations
CDN $296.00
This publication was last reviewed and confirmed in 2025.
Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations
Description
This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).
Edition
4
Published Date
2026-06-19
Status
PUBLISHED
Pages
30
Language
English
Format
Secure PDF
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Abstract
This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).
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