标准摘要
[中文适用范围]: 本文件包含针对医疗和护理人员关于高频手术设备和高频手术附件(本文档中也称为HF手术设备)的安全有效操作的指南。对负责维护此设备的科学/技术人员也有用。 本文件中的应用指南涉及根据IEC 60601-1和IEC 60601-2-2安全要求构建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符合当前国际标准的最低要求,但本文件中的指南仍有助于使用这些设备。 本报告假设高频手术设备的电气安装符合国家和地方的医疗用房规定。 [外文原描述]: IEC TR 61289:2019 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 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