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IEC 60601-2-24 Infusion Pumps and Controllers Testing

Medical electrical equipment – Part 2-24: the basic safety and essential performance of infusion pumps and controllers

IEC 60601-2-24 Scope:

IEC 60601 2 24 and EN 60601 2 24 testing applies to the basic safety and essential performance of infusion pumps and volumetric infusion controllers, hereafter referred to as medical electronic equipment.

IEC 60601-2-24 testing applies to administration sets insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers. However EN 60601-2-24 does not specify requirements or tests for other aspects of administration sets

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in IEC 60601-2-24 except in 7.2.13 and 8.4.1 of the general standard.

EN 60601-2-24 testing specifies the requirements for enteral nutrition pumps, infusion pumps, infusion pumps for ambulatory use, syringe or container pumps, volumetric infusion controllers and volumetric infusion pumps, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223.

These particular standards does not apply to the following:

  • Devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the operator);
  • Devices for extracorporeal circulation of blood;
  • Implantable devices;
  • Medical electronic equipment specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water);
  • Medical electronic equipment specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography);
  • Devices covered by ISO 28620.

Keystone Compliance assists manufacturers with IEC 60601-2-24 and EN 60601-2-24 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-24 test lab needs.