DANSK DS/EN ISO 16054 PDF

This 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 of 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.