UNE-EN IEC 60601-2-1:2021

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON accelerators, hereafter referred to as ME EQUIPMENT (MEE), 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 MEE, 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 MEE but is meant to clarify that the MEE being discussed is the EBE and not some other MEE that may be part of the system configuration.

This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively 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

·ð NOMINAL ENERGY in the range 1 MeV to 50 MeV,

·ð maximum ABSORBED DOSE RATES between 0,001 Gy x s 1 and 1 Gy x s 1 at 1 m from the RADIATION SOURCE,

·ð REFERENCE TREATMENT DISTANCES (RTDS) between 0,5 m and 2 m from the RADIATION SOURCE,

and

intended to be

·ð 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,

·ð maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,

·ð subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.

NOTE 2 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION S premises.

NOTE 3 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.



1) The general standard is IEC 60601-1:2005 + AMD1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance.



NOTE 3 The limits on maximum ABSORBED DOSE RATES are included for two reasons. The first is due to requirements related to time in this standard. This restriction limits the total dose that could be delivered during this time. (Examples: Timer, TIME TO INTERRUPT or TERMINATE, LATENCY). The second is to limit the amount of radiation damage that may occur during the time required to take action (often as a follow up to an INTERRUPTION or TERMINATION OF IRRADIATION). Wherever requirements were made to limit the amount of dose delivered before action is taken, the radiation damage was considered to be independent of the dose rate and only dependent on the dose. This would largely hold true if the dose rate stayed within this range.

IEC 61217 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 201.7.4.101).

IEC 60976:2007 specifies methods of testing and disclosure of functional performance of medical ELECTRON accelerators and is intended to facilitate comparisons of accelerator-based MEEs of different manufacture. IEC 60976:2007 contains no safety requirements, and is not required to show compliance with this standard. Until these reports are updated to match this edition of the standard, it is suggested that manufacturers replace the word ISOCENTRE with EQUIPMENT REFERENCE POINT when reading the test methods.