SRPS EN ISO 16054:2011

Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)

Scope

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

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.