標準號：BS EN 60601-2-45-2011
中文標準名稱：醫用電氣設備.乳腺X射線攝影設備和乳腺攝影立體定位器的基本安全性和必要性能的特定要求
英文標準名稱：Medical electrical equipment. Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
標準類型：C43
發布日期：2011/5/31 12:00:00
實施日期：2011/5/31 12:00:00
中國標準分類號：C43
國際標準分類號：11.040.50
引用標準：IEC 62220-1-2-2007;IEC 60601-1-2-2007;IEC 60601-1-3-2008;IEC 60336-2005;IEC 60613-2010;IEC 60788-2004;IEC 61223-3-2-2007;ISO 9236-3-1999
適用范圍：Replacement:This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofMAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter alsoreferred to as ME EQUIPMENT.NOTE 1 This includes MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS orintegrated storage phosphor subsystems.Excluded from the scope of this document are:– reconstructive tomography modes of operation;– diagnostic consoles;– picture archiving and communication systems (PACS);– non-integrated storage phosphor readers;– hard copy cameras;– films, screens and cassettes;– computer aided detection (CAD);– devices for performing core biopsy and other biopsy instruments;– modes of operation intended to demonstrate local contrast medium uptake (contrastenhanced digital mammography);If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rd edition scheme for MAMMOGRAPHIC X-RAYEQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.