STN EN ISO 15798
| Name: | STN EN ISO 15798 |
| Validity: | Valid |
| Number of pages: | 32 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Očné implantáty. Viskoelastické materiály pre očnú chirurgiu (ISO 15798: 2022) |
| English title | Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022) |
| Release Date: | 01. 05. 2022 |
| Date of withdrawal: | |
| ICS: | 11.040.70 |
| Sorting character/National clasification code | 19 5051 |
| Level of incorporation: | idt EN ISO 15798:2022, idt ISO 15798:2022 |
| Official Journal | 04/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 15798:2014-01 (19 5051) |
| Note in Official Journal: | |
| Subject of the standard: | This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery. This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices. |
| Preview: | Náhľad normy (PDF) |