IEC 63077:2019 良好的医疗成像设备翻新实践

标准编号：IEC 63077:2019

中文名称：良好的医疗成像设备翻新实践

英文名称：Good refurbishment practices for medical imaging equipment

发布日期：2019-11-13

标准范围

IEC 63077:2019描述并定义了废旧医学成像设备的翻新过程，适用于将废旧医学成像设备恢复到与新医学成像设备（即未使用的医学成像设备）相当的安全和性能条件。这种修复包括维修、返工、软件/硬件更新以及用原始零件替换磨损零件等操作。本文件列举了所执行的措施以及与相关规范和服务程序一致的方式，以确保在不改变成品医学成像设备的性能、安全规范或根据其原始或适用的有效注册的预期用途的情况下完成医学成像设备的翻新。本文件涵盖的医学影像设备和系统包括:-X射线设备；-用于放射镜引导的介入手术的X射线设备；-用于计算机断层摄影的X射线设备；-磁共振设备；-超声波诊断设备；-伽马摄像机；-平面全身成像设备；-单光子发射计算机断层扫描(SPECT)设备；-SPECT/CT混合系统，将伽马相机与用于计算机断层扫描(CT)的X射线设备相结合；-正电子发射断层摄影机(PET)；-PET/CT混合系统，其将正电子发射断层摄影机与用于计算机断层摄影术(CT)的X射线设备组合；-将正电子发射断层扫描仪与磁共振设备相结合的PET/MRI混合系统:以及-上面列出的医学成像设备或系统的其他组合。本文件不适用于内窥镜设备、眼底镜设备、放射治疗设备或相关系统。相对于IEC PAS 63077:2016，IEC 63077:2019包括以下重大技术变更:a)更清楚地界定了范围；b)增加了IEC 63077与ISO 13485（附录A）的信息性交叉引用列表；c)进行了较小的校正。

IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration.
The MEDICAL IMAGING EQUIPMENT and systems covered by this document include:
– X-RAY EQUIPMENT;
– X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES;
– X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY;
– MAGNETIC RESONANCE EQUIPMENT;
– ULTRASONIC DIAGNOSTIC EQUIPMENT;
– GAMMA CAMERAS;
– PLANAR WHOLEBODY IMAGING EQUIPMENT;
– equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT);
– SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT);
– POSITRON EMISSION TOMOGRAPHS (PET);
– PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT);
– PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and
– other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above.
This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.
IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016:
a) the scope was delineated more clearly;
b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added;
c) smaller corrections were performed.

标准预览图