Oftalmologické implantáty - Oční endotamponády (Norma k přímému použití jako ČSN).

The information about the standard:

Designation standards: ČSN EN ISO 16672
Classification mark: 195302
Catalog number: 513920
Publication date standards: 1.4.2022
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN

Annotation of standard text ČSN EN ISO 16672 (195302):

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