CAN/CSA C22.2 NO. 60601-2-24-01 (R2009) PDF

1 Scope and object

This clause of the General Standard and this clause of the Collateral Standard IEC 60601-1-2 apply, except as follows:

1.1 Scope

Addition:

This Particular Standard specifies the requirement for INFUSION PUMPS, INFUSION CONTROLLERS, SYRINGE PUMPS and PUMPS FOR AMBULATORY USE, as defined in 2.101 to 2.110. These devices are intended for use by medical staff and home PATIENTS as prescribed and medically indicated. These particular requirements do not apply to devices:

1) specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR),

2) enteral infusion,

3) extracorporeal circulation of blood,

4) implantable or disposable devices,

5) EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water);

6) EQUIPMENT specifically intended for diagnostic use within male potency testing (measurement of amount of liquid infused, necessary to maintain a preset level for maintaining penile erection: cavernosometry, cavernosography).