标准摘要
[中文适用范围]: 本文件包含针对医疗和护理人员的有关高频手术设备和高频手术配件(在本文件中也称为高频手术设备)安全有效操作的指南。它也适用于负责维护该设备的科学/技术人员。本文件中的应用指南涉及根据 IEC 60601-1 [1]1 和 IEC 60601-2-2 [4] 安全要求构造的高频手术设备的安全操作。并非所有现有的高频手术设备都满足当前国际标准的最低要求@但是@本文档中的指南仍然有助于使用这些设备。 1 方括号中的数字指的是参考书目。 [外文原描述]: IEC TR 61289:2019 contains guidelines for medical and nursing personnel regarding the safe and effective operation of HIGH FREQUENCY SURGICAL EQUIPMENT and HIGH FREQUENCY SURGICAL ACCESSORIES (also referred to as HF SURGICAL EQUIPMENT in this document). It is also of use to scientific/technical staff who have responsibility for the maintenance of this equipment. The application guidelines in this document deal with the safe operation of HIGH FREQUENCY SURGICAL EQUIPMENT constructed according to the safety requirements of IEC 60601-1 and IEC 60601-2-2. Not all existing HIGH FREQUENCY SURGICAL EQUIPMENT meets the minimum requirements of current international standards, however, the guidelines in this document is still helpful in utilizing these devices. IEC TR 61289:2019 cancels and replaces the first edition published in 2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) general adaption to IEC 60601-2-2:2017; b) refinement and additions to the defined terms; c) separation of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES; d) consideration of the HIGH CURRENT MODE; e) update of symbols.
英文名称High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance