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Standard ÖNORM EN ISO 16672 15.4.2022 preview

ÖNORM EN ISO 16672

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

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STANDARD published on 15.4.2022


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The information about the standard:

Designation standards: ÖNORM EN ISO 16672
Publication date standards: 15.4.2022
SKU: NS-1055259
The number of pages: 24
Approximate weight : 72 g (0.16 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Ophthalmic equipment

Annotation of standard text ÖNORM EN ISO 16672 :

Dieses Dokument ist anwendbar für okulare Endotamponaden (OE), eine Klasse nicht-solider chirurgisch invasiver Medizinprodukte, die in dem Glaskörperraum zur Glättung und zum Anlegen einer abgelösten Retina an das retinale Pigmentepithel (RPE) oder als Retinatamponade verwendet werden. Mit Bezug auf die Sicherheit und Effektivität von OE legt dieses Dokument Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, präklinische und klinische Bewertung, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller fest.

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