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    IEC 60601-2-1:2020

    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
    • 발행일 : 2020-10-28
    • 발행기관 : IEC
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분야 TC 62/SC 62C : Equipment for radiotherapy, nuclear medicine and radiation dosimetry
적용범위 IEC 60601-2-1:2020 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.
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
• maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and
• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE;
and
– intended to be
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new relevant collateral standards;
b) addition of computer interface and control;
c) addition of new technologies in RADIOTHERAPY, including
• BEAM GATING, and
• ADAPTIVE RADIOTHERAPY.
국제분류(ICS)코드 11.040.60 : 치료장비
페이지수 232
Edition 4.0

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-1:2020상세보기 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 2020-10-28 표준
2 IEC 60601-2-1:2009+AMD1:2014 CSV상세보기 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 2014-07-21 구판
3 IEC 60601-2-1:2009/AMD1:2014상세보기 Amendment 1 - 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 2014-07-21 구판
4 IEC 60601-2-1:2009상세보기 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 2009-10-13 구판
5 IEC 60601-2-1:1998/AMD1:2002상세보기 Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV 2002-05-08 구판
6 IEC 60601-2-1:1998상세보기 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV 1998-06-30 구판
7 IEC 60601-2-1:1981/AMD2:1990상세보기 Amendment 2 - 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 1990-02-28 구판
8 IEC 60601-2-1:1981/AMD1:1984상세보기 Amendment 1 - 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 1984-01-01 구판
9 IEC 60601-2-1:1981상세보기 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 1981-01-01 구판

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