STN EN ISO 16054
| Name: | STN EN ISO 16054 |
| Validity: | Valid |
| Number of pages: | 18 |
| 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 | Chirurgické implantáty. Minimálne súbory údajov pre chirurgické implantáty (ISO 16054: 2019) |
| English title | Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019) |
| Release Date: | 01. 12. 2019 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 2904 |
| Level of incorporation: | idt EN ISO 16054:2019, idt ISO 16054:2019 |
| Official Journal | 11/19 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 16054:2003-11 (85 2904) |
| Note in Official Journal: | |
| Subject of the standard: | This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event. |
| Preview: | Náhľad normy (PDF) |