YY/T 0682-2008 in English

本标准定义了植入物登记、跟踪和取出分析为目的的外科植入物用最小资料群。
本标准适用于植入性医疗器械的制造商、分销商，以及执行植入操作的医院和其他医疗机构。

Scope

This standard defines a minimum data set for surgical implants for the purpose of implant registration, tracking, and removal analysis. Its role is to facilitate recording and international data exchange. The minimum data set required is collected for implant tracking purposes so that when unpredictable device defect events occur, patients can be traced and defective devices recalled. The minimum data group also satisfies the core data requirements for mutual reference between extended data groups for extraction and analysis purposes and for research purposes. This standard applies to manufacturers and distributors of implantable medical devices (implanted for more than 30 days), as well as hospitals and other medical institutions that perform implantation operations. This standard specifies specific requirements for the data items that should be recorded by manufacturers and distributors of implantable medical devices, hospitals, and other medical institutions at the time of implantation and removal at any time after surgery. The purpose of this standard is to define the minimum set of data used to record all implantation and removal events. It also provides for quick querying of implant data associated with specific patient groups to facilitate patient tracking. device or the patient population of a certain batch of devices. This standard is not intended to collect relevant data from a specific medical practitioner, medical institution or manufacturer, but rather to track patients.