Addition: This Particular Standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of ELECTRON ACCELERATORS - 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), - that, under NORMAL CONDITIONS (NC) and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION and/or ELECTRON RADIATION radiation having · NOMINAL ENERGY in the range 1 MeV to 50 MeV, · maximum ABSORBED DOSE RATES between 0,001 Gy × s and 1 Gy × s at 1 m from the RADIATION SOURCE, · NOTMAL TREATMENT DISTANCES (NTDS) between 0,5 m and 2 m from the RADIATION SOURCE, and - 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, · used within the environmental and electrical supply conditions SPECIFIED in the technical description. note:1) In this Particular Standard, all references to installation refer to installation in the USER's premises. 2) See ICRP 33 (128) - (134) and (144) - (156). 3) In this Particular Standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
IEC 60601-2-1-1998由国际电工委员会 IX-IEC 发布于 1998-06。
IEC 60601-2-1-1998 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。
非常抱歉,我们暂时无法提供预览,您可以试试: 免费下载 IEC 60601-2-1-1998 前三页,或者稍后再访问。
点击下载后,生成下载文件时间比较长,请耐心等待......
Copyright ©2007-2022 ANTPEDIA, All Rights Reserved
京ICP备07018254号 京公网安备1101085018 电信与信息服务业务经营许可证:京ICP证110310号