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ISO 16672:2020

Ophthalmic implants — Ocular endotamponades
26. 6. 2020.

Опште информације

90.60     3. 9. 2025.

ISO

ISO/TC 172/SC 7

Međunarodni standard

11.040.70  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 16672:2015

TRENUTNO

OBJAVLJEN
ISO 16672:2020
90.60 Završetak postupka preispitivanja standarda
3. 9. 2025.

Nacionalna preuzimanja

SRPS EN ISO 16672 :2022  
ISS

Oftalmološki implantati – Unutrašnja tamponada oka

60.60   Standard objavljen

Z172 Saznaj više