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IEC 60601-2-1 Electron Accelerators Testing

Medical electrical equipment – Part 2-1: the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

IEC 60601-2-1 Scope:

IEC 60601 2 1 and EN 60601 2 1 testing applies to the basic safety and essential performance of electron accelerators, hereafter referred to as medical electronic equipment, in the range 1 MeV to 50 MeV, used for treatment of patients.

IEC 60601-2-1, 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 X-radiation 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 EN 60601-2-1 testing, all references to installation refer to installation in the responsible organization’s premises.

NOTE 2 In IEC 60601-2-1, all references to absorbed dose refer to absorbed dose in water.

IEC 61271 gives guidance on the designation of medical electronic equipment movements; the marking of scales, their zero positions and the direction of movement with increasing value (see 201.7.4.101).

IEC 60676 specifies methods of testing and disclosure of functional performance of medical electron accelerators. The standard is intended to facilitate comparisons of accelerator-based medical electronic 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.

Keystone Compliance assists manufacturers with IEC 60601-2-1 and EN 60601-2-1 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-1 test lab needs.