UNE-EN ISO 15798:2022
Current
The latest, up-to-date edition.
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
Hardcopy , PDF
English, Spanish, Castilian
21-09-2022
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasivemedical devices with viscous and/or viscoelastic properties, intended for use during surgery inthe anterior segment of the human eye. OVDs are designed to create and maintain space, to protectintraocular tissues and to manipulate tissues during surgery.This document specifies requirements with regard to safety for the intended performance, designattributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling andinformation supplied by the manufacturer of these devices.
| Committee |
CTN 91
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 15798:2022 | Equivalent |
| DIN EN ISO 15798:2022-05 | Equivalent |
| I.S. EN ISO 15798:2022 | Equivalent |
| EN ISO 15798:2022 | Identical |
| ISO 15798:2022 | Identical |
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