EN IEC 60601-2-16:2019

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Publication date:   Nov 14, 2019

Scope

<span style="color:red">NEW!</span>IEC 60601-2-16:2018 is available as <a href="https://webstore.iec.ch/publication/63018">IEC 60601-2-16:2018 RLV</a> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.</br></br>IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 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. IEC 60601-2-16:2018 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. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition:

a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015;

b) widening of the scope;

c) editorial improvements;

d) addition of requirements for anticoagulant delivery means;

e) other few small technical changes.