IEC 60601-2-16:2008/COR1:2008

IEC 60601-2-16
(Third edition – 2008)
Medical electrical equipment –
Part 2-16: Particular requirements for basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment

CORRIGENDUM 1
Page 17
201.7.9.2.5 ME EQUIPMENT description
In the sixth dashed item, instead of:
“.PHYSIOLOGICAL CLOSED LOOP CONTROLLER.”
read:
“.PHYSIOLOGIC CLOSED-LOOP CONTROLLER…”
Page 26
201.12.4.4.105 * Air infusion
In item b), on page 27, in the first and seventh dashed items of the bullet point
entitled “Continuous air infusion”, instead of:
“.g cannula.”
read:
“.gauge cannula.”
In item b), on page 28, in the first dashed item of the bullet point entitled “Bolus air infusion”,
instead of:
“Set up the HAEMODIALYSIS EQUIPMENT with a DIALYSER with a standard capillary DIALYSER with
2 2
a surface area between 1 m and 1,5 m , the recommended EXTRACORPOREAL CIRCUIT and 16
g cannulas.”
read:
“Set up the HAEMODIALYSIS EQUIPMENT with a standard capillary DIALYSER with a surface area
2 2
between 1 m and 1,5 m , the recommended EXTRACORPOREAL CIRCUIT and 16 gauge
cannulas.”
In Note 7, following the second dashed item of the bullet point entitled “Bolus air infusion”,
instead of:
“.If degassed dialysate is.”
read:
“.If degassed DIALYSING FLUID is.”
October 2008
Page 34
208.6.3.3.2 Volume of auditory ALAR
...