ČSN EN ISO 16672

Detailinformationen

Bezeichnung: ČSN EN ISO 16672

Ausgabedatum: 01.04.2022

Seiten: 28

Land: Tschechische technische Norm

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Erhältlich auf www.technormen.de

Annotation

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer