IEC TR 61289:2019 高频外科设备和高频外科附件.操作和维护

标准编号：IEC TR 61289:2019

中文名称：高频外科设备和高频外科附件.操作和维护

英文名称：High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

发布日期：2019-05-10

标准范围

IEC TR 61289:2019作为IEC TR 61289:2019 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC TR 61289:2019包含医疗和护理人员安全有效操作高频手术设备和高频手术附件（在本文档中也称为HF手术设备）的指南。它对负责维护该设备的科学/技术人员也很有用。本文件中的应用指南涉及根据IEC 60601-1和IEC 60601-2-2的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，然而，本文件中的指南仍然有助于利用这些设备。IEC TR 61289:2019取消并取代2011年发布的第一版。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)一般适应IEC 60601-2-2:20 17；b)对所定义的术语的细化和补充；c)高频手术设备和高频手术附件的分离；d)考虑高电流模式；e)符号的更新。

IEC TR 61289:2019 is available as IEC TR 61289:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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.

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