IEC 60601-2-1:2009
医用电气设备.第2-1部分:1至50MeV范围内医用电子加速器的基本安全性和基本性能用详细要求

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

被代替

IEC 60601-2-1:2009 发布历史

IEC 60601-2-1:2009由国际电工委员会 IX-IEC 发布于 2009-10，并于 2014-08-09 实施。

IEC 60601-2-1:2009 在中国标准分类中归属于: C39 医用电子仪器设备，在国际标准分类中归属于: 11.040.50 射线照相设备。

IEC 60601-2-1:2009的历代版本如下：

• 2020年 IEC 60601-2-1:2020 医疗电气设备 - 第2-1部分:电子加速器的基本安全性和基本性能的特殊要求范围1 Mev至50 Mev
• 2014年 IEC 60601-2-1:2009/AMD1:2014 医疗电气设备. 第2-1部分: 取值范围为1 MeV至50 MeV的电子加速器的基本安全和基本性能的详细要求
• 2014年 IEC 60601-2-1:2014 医疗电气设备. 第2-1部分: 取值范围为1 MeV至50 MeV的电子加速器的基本安全和基本性能的详细要求
• 2009年 IEC 60601-2-1:2009 医用电气设备.第2-1部分:1至50MeV范围内医用电子加速器的基本安全性和基本性能用详细要求
• 2002年 IEC 60601-2-1/AMD1:2002 医疗电气设备.第2-1部分:1-50MeV范围内医用电子加速器安全的特殊要求.修改件1
• 1998年 IEC 60601-2-1:1998 医用电气设备 第2-1部分:能量为1MeV至50MeV医用电子加速器安全专用要求
• 1990年 IEC 60601-2-1/AMD2:1990 Modification 2 a la Publication 601-2-1 (1981) Safety of Medical Electrical Equipment Part 2: Particular Requirements for Medical Electron Accelerators in the Range 1 MeV to 50 MeV Section One: General Section Two: Radiation Safety for Equipment (Edition
• 1984年 IEC 60601-2-1/AMD1:1984 医疗电气设备.第2部分:1-50MeV范围内医用电子加速器的特殊要求.第1节:总则.第2节:设备的辐射安全.第1次修改
• 1981年 IEC 60601-2-1:1981 医疗电气设备.第2部分:1-50MeV范围内医用电子加速器的特殊要求.第1节:总则.第2节:设备的辐射安全

IEC 60601-2-1:2009 医用电气设备.第2-1部分:1至50MeV范围内医用电子加速器的基本安全性和基本性能用详细要求 于 2015-08-31 变更为 BS EN ISO 4823:2015 牙科学.弹性印模材料。

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS@ hereafter referred to as ME EQUIPMENT@ in the range 1 MeV to 50 MeV@ used for treatment of PATIENTS. This particular standard@ with the inclusion of TYPE TESTS and SITE TESTS@ applies respectively to the manufacture and some installation aspects of ELECTRON ACCELERATORS ?C intended for RADIOTHERAPY in human medical practice@ including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS)@ ?C that@ under NORMAL CONDITIONS and in NORMAL USE@ deliver a RADIATION BEAM of XRADIATION and/or ELECTRON RADIATION having ? NOMINAL ENERGY in the range 1 MeV to 50 MeV@- ? maximum ABSORBED DOSE RATES between 0@001 Gy ?? s?C1 and 1 Gy ?? s?C1 at 1 m from the RADIATION SOURCE@ ? NORMAL TREATMENT DISTANCES (NTDs) between 0@5 m and 2 m from the RADIATION SOURCE@ and ?C intended to be ? for NORMAL USE@ operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application@ for particular specified clinical purposes@ e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY@ ? maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE@ ? subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE 1 In this particular standard@ all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises. NOTE 2 In this particular standard@ all references to ABSORBED DOSE refer to ABSORBED DOSE in water.

标准号

IEC 60601-2-1:2009

发布

2009年

发布单位

国际电工委员会

替代标准

IEC 60601-2-1:2014

当前最新

IEC 60601-2-1:2020

 

 

被代替标准

IEC 62C/474/FDIS:2009 IEC 60601-2-1:1998 IEC 60601-2-1 AMD 1:2002

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