Utrustning för ögonoptik

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 18 apr 2023
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This document provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid gas-permeable (RGP) contact lenses intended for multipatient use.
This document does not apply to:
— labelling of contact lenses;
— the inactivation of prions and viruses since there are no standardised methods available for contact lenses.
This document can be used as guidance for the development of a hygienic management procedure for multipatient use.
NOTE ISO 14729 does not cover multipatient use.

Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 3 maj 2023
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This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.