ÖNORM EN ISO 16054

This International Standard 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 implant 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 cross referencing between extended data sets for the purposes of retrieval analysis and research. This International Standard is applicable to the manufacturers and distributors of medical devices intended for permanent implant, i.e. more than 30 days and to those hospitals and other medical facilities which carry out implant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of permanently implantable medical devices and by hospitals and other medical facilities at both the time of implant and at the time of any subsequent explant procedure. 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 numbers, 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. NOTE Users of this International Standard should ensure compliance with appropriate national standards or regulations concerning data protection and handling.