STN EN ISO 16672
| Name: | STN EN ISO 16672 |
| Validity: | Valid |
| Number of pages: | 28 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Očné implantáty. Očné endotamponáže (ISO 16672: 2020) |
| English title | Ophthalmic implants - Ocular endotamponades (ISO 16672:2020) |
| Release Date: | 01. 01. 2022 |
| Date of withdrawal: | |
| ICS: | 11.040.70 |
| Sorting character/National clasification code | 19 5302 |
| Level of incorporation: | idt EN ISO 16672:2021, idt ISO 16672:2020 |
| Official Journal | 12/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 16672:2016-01 (19 5302) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |