This document 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.

This document 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 document 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 document 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.

Cross References:
ISO/IEC 15459-3
ISO/IEC 15459-2
ISO/IEC 15418
ISO/IEC 15459-4
ISO/IEC 16388
ISO/IEC 15417
ISO/IEC 15459-1
ANSI/HIBC 2.5:2015
ISO/HL7 27931
ISO/IEC 15459-5
ISO/IEC 15459-6
ISO/HL7 10781
ISO/IEC 15420


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