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ISO 11980:2025

Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations

Jun 20, 2025

General information

60.60     Jun 20, 2025

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

English   French  

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Published

Language in which you want to receive the document.

Scope

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).

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11980:2012

NOW

PUBLISHED
ISO 11980:2025
60.60 Standard published
Jun 20, 2025

National adoptions

dnaSRPS EN ISO 11980:2022  
ISS

Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO 11980:2025)

50.60   Close of voting. Proof returned by secretariat

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