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

Clause 1 of the general standard1 applies, except as follows:

201.1.1 Scope

Replacement:

This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT.

This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However this standard does not specify requirements or tests for other aspects of ADMINISTRATION SETS

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard 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 standard does not apply to the following:

a) devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR);
b) devices for extracorporeal circulation of blood;
c) implantable devices;
d) 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);
e) ME 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);
f) devices covered by ISO 28620.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE 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.