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现行 IEC TR 61289:2019 RLV
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High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance 高频外科设备和高频外科附件.操作和维护
发布日期: 2019-05-10
IEC TR 61289:2019 RLV包含IEC官方国际标准及其红线版本。Redline版本不是官方文档,它只有英文版本,为您提供了一种快速简单的方法来比较IEC官方标准与其以前版本之间的所有变化。 IEC TR 61289:2019包含针对医疗和护理人员的关于高频手术设备和高频手术附件(在本文件中也称为HF手术设备)安全有效操作的指南。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-的安全要求建造的高频手术设备的安全操作。1和IEC 60601-2-2。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 RLV contains both the official IEC International Standard and its Redline version. The Redline version is not an official document, it 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.
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研制信息
归口单位: TC 62/SC 62D
相似标准/计划/法规
现行
BS PD IEC TR 61289-2019
High frequency surgical equipment and high frequency surgical accessories. Operation and maintenance
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2019-05-13
现行
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AAMI/IEC TIR61289-2011
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医用电气设备
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AS/NZS IEC 60601.2.2-2016
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医用电气设备 第2.2部分:高频外科设备和高频外科附件基本安全和基本性能的特殊要求
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의료용 전기기기 — 제2-2부: 고주파 수술기 및 고주파 수술 부속품의 기본 안전 및 필수 성능에 관한 개별 요구사항
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Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
医用电气设备.第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求
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现行
IEC 60601-2-2-2017+AMD1-2023 CSV
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医用电气设备.第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求
2023-02-21
现行
AAMI/IEC 60601-2-2-2017
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
医用电气设备第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求
2017-06-30
现行
UNE-EN 60601-2-2-2010
Medical electrical equipment -- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
医用电气设备第2-2部分:高频外科设备和高频外科附件基本安全和基本性能的特殊要求
2010-01-13
现行
DIN EN 60601-2-2 Supplement 1
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories; Supplement 1: High frequency surgical equipment - Operation and maintenance (IEC/TR 61289:2011)
医用电气设备.第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求;补充件1:高频外科设备-操作和维护(IEC/TR 61289-2011)
2014-02-01
现行
IEC 60601-2-2-2017/AMD1-2023
Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
修改件1.医用电气设备.第2-2部分:高频外科设备和高频外科附件的基本安全和基本性能的特殊要求
2023-02-21
现行
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2006-08-11
现行
CSA C22.2 NO.60601-2-2-19
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Adopted IEC 60601-2-2:2017, sixth edition, 2017-03, with Canadian deviations)
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2019-03-01
现行
DIN EN IEC 60601-2-2
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2017); German version EN IEC 60601-2-2:2018
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CAN/CSA C22.2 NO.601.2.2-92
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医用电气设备第2部分:高频外科设备安全的特殊要求(采用IEC 601-2-2-1990)
1992-04-01
现行
CAN/CSA 601.2.2-92
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of High-Frequency Surgical Equipment (Adopted IEC 601-2-2:1990)
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