UNE-EN ISO 16054:2020

This International Standard 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. It is noted that the challenge in the creation of cross referenceable datasets lies with the definition and consistent application of a basic dataset and this standard may provide the initial list for tracking, however, in order support for instance retrieval analysis, a more extensive dataset may be required.This International Standard 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.This International Standard is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.It is not the intent of this International Standard to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.NOTE Users of this International Standard are reminded to apply appropriate national standards or regulations concerning data protection and handling.