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IEC 60601-2-1

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

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Organization: IEC
Publication Date: 1 July 2014
Status: active
Page Count: 134
ICS Code (Therapy equipment): 11.040.60
scope:

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

- 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 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-1 and 1 Gy × s-1 at 1 m from the RADIATION SOURCE,

NORMAL 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 c0. linical 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.

Document History

IEC 60601-2-1
July 1, 2014
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
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...
July 1, 2014
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
A description is not available for this item.
October 1, 2009
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
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...
May 1, 2002
Medical Electrical Equipment - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV
Addition: This Particular Standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation1) aspects of ELECTRON ACCELERATORS2) - intended...
June 1, 1998
Medical Electrical Equipment - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV
A description is not available for this item.
February 1, 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
The test procedures described in this amendment are classified in three grades: GRADE A  Inspection of the analysis of equipment design provided by the manufacturer as related to the specified...
December 1, 1984
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
INTRODUCTION This amendment to the Particular Standard specifies the particular requirements for the electrical and mechanical safety of MEDICAL ELECTRON ACCELERATORS. It forms a further section of...
January 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
A description is not available for this item.

References

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