Publikuar
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).
WITHDRAWN
ISO 11980:2012
PUBLISHED
ISO 11980:2025
60.60
Standard published
20 qer 2025
Optikat oftalmike - Lentet e kontaktit dhe produktet e kujdesit për lentet e kontaktit - Udhëzues për investigimet klinike (ISO 11980:2025)
40.20 DIS ballot initiated: 12 weeks
English