UNE-EN ISO 16672:2021
Current
The latest, up-to-date edition.
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020) (Endorsed by Asociación Española de Normalización in November of 2021.)
Hardcopy , PDF
English
01-11-2021
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.
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 16672:2021 | Identical |
| ISO 16672:2020 | Identical |
| I.S. EN ISO 16672:2021 | Equivalent |
| BS EN ISO 16672:2021 | Equivalent |
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