Medical electrical equipment Part 2: Particular safety requirements for infusion pumps and controllers

2Scope / Description

This specific standard specifies the requirements for infusion pumps, infusion controllers, syringe pumps, and portable infusion pumps, defined in Clauses 2.101 to 2.110. These devices are intended for use by healthcare professionals and home patients as prescribed and medically directed. These specific requirements do not apply to: 1) devices specifically intended for diagnostic or similar purposes (e.g., angiography or other pumps permanently controlled or supervised by an operator); 2) devices specifically intended for enteral infusion; 3) devices specifically intended for extracorporeal blood circulation; 4) implantable or disposable devices; 5) devices specifically intended for diagnostic purposes within urodynamics (measuring the pressure-volume relationship of the bladder when the bladder is filled with water via a catheter); and 6) devices specifically intended for diagnostic purposes within male erectile function testing (measuring the amount of fluid required to maintain a set pressure level to maintain penile erection: penile corpus cavernosum measurement, penile corpus cavernosum angiography).