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.
Diese ÖNORM legt Mindestdatensätze für chirurgische Implantate zur Vereinfachung von Datenaufzeichnung und internationalem Datenaustausch zum Zweck der Implantatregistrierung und Implantatrückverfolgbarkeit und der Analyse von entommenen Implantaten fest. Mindestdatensätze werden zum Zweck der Rückverfolgung von Implantaten festgelegt und ermöglichen den Rückruf zur Produktkorrektur oder eine Patienten-Nachbehandlung im Fall unverhergesehener Implantatfehlkonstruktionen. Der mindesterforderliche Datensatz erfüllt außerdem die Anforderungen an die Kerndaten, die Querverweisungen zwischen erweiterten Datensätzen zum Zweck der Analyse entnommener Implantate und der Forschung ermöglichen.