ISO 16672:2020
Current
The latest, up-to-date edition.
Ophthalmic implants Ocular endotamponades
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
26-06-2020
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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 |
18
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ÖNORM EN ISO 16672:2022 04 15 | Identical |
| EN ISO 16672:2021 | Identical |
| I.S. EN ISO 16672:2021 | Identical |
| BS EN ISO 16672:2021 | Identical |
| SN EN ISO 16672:2021 | Identical |
| PN-EN ISO 16672:2022-03 | Identical |
| UNE-EN ISO 16672:2021 | Identical |
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