BS ISO 16054 : 2000 AMD 14017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 implantable medical device
3.2 implant event
3.3 explant event
3.4 medical facility
4 Data sets
4.1 General
4.2 Supplier data
4.3 Medical facility data
Annex A (informative) Automated device
        labelling and data capture

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 to allow recall for product correction or partient follow up in the event of unforeseen device malfunction. The minimum data set also fulfills 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 manufacturers and distributors of medical devices intended for permanent implant, i.e. means more than 30 days and to those hospitals and other medical facilities which carry out implant procedures.