ČSN EN ISO 11980

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

Available languages: English

Available design: Print design

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Detail information

Designation: ČSN EN ISO 11980

Publication date: 01/12/2025

Pages: 44

Country: Czech technical standard

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Anotation

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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