標準號：BS ISO 16054-2001
中文標準名稱：外科植入物.外科植入物的*小數據集
英文標準名稱：Implants for surgery - Minimum data sets for surgical implants
標準類型：C35
發布日期：2001/3/15 12:00:00
實施日期：2001/3/15 12:00:00
中國標準分類號：C35
國際標準分類號：11.040.40
適用范圍：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 pa-tient follow up in the event of unforeseen device malfunction. The minimum data set also fulfils the core data require-ments 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 per-manent 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 perma-nently 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 con-cerning data protection and handling.