AAMI IEC-60601-2-16 pdf download.Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.
The DIALYSIS FLUID flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as specified by the MANUFACTURER .
NOTE A DIALYSIS FLUID flow rate lower than the set value is considered detrimental for a typical treatment.
Compliance is checked under the following test conditions:
– set the HAEMODIALYSIS EQUIPMENT to the HAEMODIALYSIS mode as specified by the MANUFACTURER ;
– set the HAEMODIALYSIS EQUIPMENT to maximum DIALYSIS FLUID flow rate;
– measure the DIALYSIS FLUID flow rate over a period of 30 min;
– set the HAEMODIALYSIS EQUIPMENT to minimum DIALYSIS FLUID flow rate;
– measure the DIALYSIS FLUID flow rate over a period of 30 min.
The values of the DIALYSIS FLUID flow rate shall be within the tolerances specified by the MANUFACTURER in the instructions for use.
201 .4.3.1 04 N ET FLUID REMOVAL
The NET FLUID REMOVAL of the HAEMODIALYSIS EQUIPMENT shall be achieved as specified by the MANUFACTURER .
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT only:
– set the HAEMODIALYSIS EQUIPMENT in the HAEMODIALYSIS mode, if applicable, with a DIALYSER according to the MANUFACTURER ’ S recommendation;
– apply fluid (e.g. water) in THE EXTRACORPOREAL CIRCUIT ;
– set the highest DIALYSIS FLUID flow rate, if applicable;
– set the DIALYSIS FLUID temperature to 37 °C, if applicable;
– set the NET FLUID REMOVAL rate to 0 ml/h or the lowest adjustable value;
– create a DIALYSER blood outlet pressure of 50 mmHg below the highest operating pressure specified by
the MANUFACTURER ;
– measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 2:
– set the NET FLUID REMOVAL rate to the maximum value;
– measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 3:
– create a DIALYSER blood outlet pressure of 20 mmHg above the lowest operating pressure specified by the MANUFACTURER ;
– measure the NET FLUID REMOVAL during an appropriate time interval.
The values of the NET FLUID REMOVAL shall be within the tolerances specified by the MANUFACTURER in the instructions for use.
201 .4.3.1 05 S UBSTITUTION FLUID flow rate For HAEMOFILTRATION and HAEMODIAFILTRATION EQUIPMENT only.
The SUBSTITUTION FLUID flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as specified by the MANUFACTURER .
NOTE A SUBSTITUTION FLUID flow rate lower than the set value is considered detrimental for a typical treatment.
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT and of the therapeutic relevant SUBSTITUTION FLUID flow rate:
– set the HAEMODIALYSIS EQUIPMENT to the HDF or HF mode with a DIALYSER according to the
MANUFACTURER ’s recommendation;
– apply fluid (e.g. water) in the EXTRACORPOREAL CIRCUIT ;
– set the NET FLUID REMOVAL flow rate to 0 ml/h, or – if not possible – to the minimum;
– set the maximum SUBSTITUTION FLUID flow rate;
– set the temperature of the SUBSTITUTION FLUID to 37 °C, if applicable;
– measure the SUBSTITUTION FLUID flow rate and the NET FLUID REMOVAL .
Continue with test 2:
– set the minimum SUBSTITUTION FLUID flow rate;
– measure the SUBSTITUTION FLUID flow rate and the NET FLUID REMOVAL .
The values of SUBSTITUTION FLUID flow rate and NET FLUID REMOVAL shall be within the tolerances specified by the MANUFACTURER in the instructions for use.
201 .4.3.1 06 Dialysis time
The accuracy of the dialysis treatment time for the HAEMODIALYSIS EQUIPMENT shall be as specified by the MANUFACTURER .
Compliance is checked by functional tests relevant for the definition of dialysis treatment time specified by the MANUFACTURER .
201 .4.3.1 07 * D IALYSIS FLUID composition
The test method for accuracy of the composition of the DIALYSIS FLUID shall be specified by the MANUFACTURER and compliance checked accordingly.
201 .4.3.1 08 D IALYSIS FLUID temperature
The temperature of the DIALYSIS FLUID shall be achieved as specified by the MANUFACTURER .
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the DIALYSIS FLUID .
Compliance is checked under the following test conditions:
– let the HAEMODIALYSIS EQUIPMENT run until it is thermally stable at environmental conditions within 20 °C to 25 °C;
– set the DIALYSIS FLUID temperature to 37 °C, if applicable;
– set the highest DIALYSIS FLUID flow rate;
– measure the temperature at the DIALYSER inlet;
– record the temperature during a period of 30 min;
– set the lowest DIALYSIS FLUID flow rate;
– measure the temperature at the DIALYSER inlet;
– record the temperature during a period of 30 min.
The values of the DIALYSIS FLUID temperature shall be within the tolerances specified by the MANUFACTURER in the instructions for use.AAMI IEC-60601-2 pdf download.