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BS EN ISO 16672:2021

Current

Current

The latest, up-to-date edition.

Ophthalmic implants. Ocular endotamponades

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

14-10-2021

€217.36
Excluding VAT

Committee
CH/172/7
DocumentType
Standard
ISBN
9780580950032
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

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.

Standards Relationship
ISO 16672:2020 Identical
EN ISO 16672:2021 Identical

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