EN ISO 16054:2002

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Data sets
Annex A (informative) Automated device labelling and
         data capture
Annex ZA (normative) Normative references to international
          publications with their relevant European
          publications

This international standard defines minimum data sets to facilitate recording and international exchange of data for the purposes of 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 permanently implantable medical devices 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.It is intended that this International Standard provide for the capture of a defined minimum data set for all implant and explant events. This International Standard provides for the timely retrieval of minimum implants 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 practioners, medical facilities or manufacturers for purposes other than patient follow up