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 (IEC 60601-2-1:2009 + A1:2014)
Clause 1 of the general standard1) applies, except as follows: 201.1.1 Scope 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 – 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 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. IEC 61271 gives guidance on the designation of ME EQUIPMENT movements; the marking of scales, their zero positions and the direction of movement with increasing value (see 22.214.171.124). IEC 60676 specifies methods of testing and disclosure of functional performance of medical ELECTRON ACCELERATORS. The standard is intended to facilitate comparisons of acceleratorbased ME EQUIPMENTs of different manufacture. IEC 60676 contains no safety requirements, and is therefore not required for compliance with this particular standard. It should also be noted (as stated in the Introduction to IEC 60976:2007) that tests specified in IEC 60976 are not necessarily appropriate for ensuring that any individual medical ELECTRON ACCELERATOR conforms to the declared functional performance during the course of its working lifetime. NOTE 3 IEC/TR 60977, Medical electrical equipment – Medical electron accelerators – Guidelines for functional performance characteristics, is a related technical report that provides performance guidelines. It shall not be construed as a standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTRON ACCELERATORS in the range 1 MeV to 50 MeV and to specify tests to check compliance to those requirements. NOTE The adoption of this standard helps to ensure that the ME EQUIPMENT • maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS, • delivers the pre-selected RADIATION TYPE, NOMINAL ENERGY, and ABSORBED DOSE, • delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT, by utilizing STATIONARY RADIOTHERAPY, MOVING BEAM RADIOTHERAPY, RADIATION BEAM modifying devices, etc., without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.
: 13 900,0 Ft
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