Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (First revision) (IEC 60601-2-16:2012, IDT)
This Malaysian Standard applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.
This standard does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety.
This standard specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise.
This standard includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure
Published
• (none) / (none) / MS IEC 60601-2-16:2007
PDF
13/05/2019
71
NSC 18 - Medical Devices and Facilities for Healthcare
