医用电气设备 第2-37部分：超声医用诊断和监护设备基本安全和基本性能的特殊要求

[中文适用范围]： 本文件适用于超声诊断设备（定义为201.3.217中定义的ME设备）的基本安全和基本性能。如果某个条款或子条款明确仅适用于ME设备或ME系统，则该条款或子标题的内容会说明这一点。否则，该条款或子条款同时适用于ME设备和ME系统（视情况而定）。ME设备或ME系统在本文档范围内的预期生理功能固有的危险，在本文档中没有具体规定，除非在201.7.2.13条中。本文件不涉及超声治疗设备。结合其他医疗程序利用超声波对身体结构进行成像或诊断的设备包含在内。 [外文原描述]： IEC 60601-2-37:2024 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.