ISO 16054:2019 外科植入物 外科植入物的最小数据集

标准编号：ISO 16054:2019

中文名称：外科植入物 外科植入物的最小数据集

英文名称：Implants for surgery — Minimum data sets for surgical implants

发布日期：2019-07

标准范围

本文件定义了植入物的最低数据集，以便于为植入物跟踪系统记录和国际数据交换。这些数据也可用于支持检索分析和植入物登记。本文件适用于通过外科手术植入的医疗设备的制造商和分销商，以及进行植入或外植手术的医院和其他医疗设施。它规定了植入物制造商和分销商以及医院和其他医疗机构在植入物事件发生时和任何后续植入物事件发生时记录的数据项的要求。本文件旨在定义所有植入物和外植体事件记录的最低数据集，并提供及时检索与特定患者子集相关的最低植入物数据，这些患者已收到特定识别设备或在指定批次、批次或序列代码范围内的设备，以便进行患者随访。本文件的目的不是提供与特定医生、医疗设施或制造商相关的数据恢复方法，用于发生意外设备故障时的患者随访或产品召回以外的目的。

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.

标准预览图