What is BS EN 60601-2-24 – Safety and performance of Infusion pumps and controllers about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-24 is the twenty-fourth subpart of the second part of a multi-part series that provides the basic safety and essential performance of infusion pumps and volumetric infusion controllers hereafter referred to as medical electrical equipment that ensures the practical degree of safety in the operation of infusion pumps and controllers.
BS EN 60601-2-24 applies to administration sets insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers.
BS EN 60601-2-24 outlines 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.
Note 1: BS EN 60601-2-24 does not specify requirements or tests for other aspects of administration sets
Note 2: Hazards inherent in the intended physiological function of me equipment or me systems within the scope of BS EN 60601-2-24 are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standards.
Note 3: BS EN 60601-2-24 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
- ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water)
- ME EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of the amount of liquid infused, necessary to maintain a pre-set pressure level for maintaining a penile erection: cavernosometry, cavernosography)
- Devices covered by ISO 28620
Who is BS EN 60601-2-24 - Safety and performance of Infusion pumps and controllers for?
BS EN 60601-2-24 on basic safety and performance of infusion pumps and controllers is useful for:
- Manufacturers of infusion pumps and controllers
- Operators and technical staff for infusion pumps and controllers
- Medical test laboratories
- Regulatory authorities
Why should you use BS EN 60601-2-24 - Safety and performance of Infusion pumps and controllers?
The infusion pump is medical electrical equipment intended to regulate the flow of liquids into the patient under pressure generated by the pump. An infusion pump for ambulatory use is intended to be carried continuously by the patient.
BS EN 60601-2-24 guideline assists you with general requirements for testing of medical electrical equipment, protection against electrical hazards, protection against mechanical hazards, protection against unwanted, protection against excessive radiation hazards, protection against excessive temperatures, and other hazards for basic safety and essential performance of infusion pumps and controllers.
BS EN 60601-2-24 also provides guidance on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, electromagnetic compatibility, alarm systems in medical electrical equipment for infusion pumps and controllers.
With obedience and compliance to BS EN 60601-2-24, you can enhance the efficacy and standardise the performance of infusion pumps and controllers. In addition, ensures the health and safety of patients and operators.