NEN-ISO 16054
Implants for surgery - Minimum data sets for surgical implants
| Organization: | NEN |
| Publication Date: | 1 March 2001 |
| Status: | inactive |
| Page Count: | 14 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
Defines minimum data sets for surgical implants to facilitate recording and international exchange of data for the purposes of implant registry and tracking systems and for retrieval analysis. Minimum data collection requirements are specified for the purpose of imlant tracking to allow recall for product correction or patient follow up in the event of unforeseen device malfunction. The minimum data set also fulfils the core data requirements to allow across referencing between extended data sets for the purposes of retrieval analysis and reseach.
Document History