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  • BSI
    BS EN 60601-2-16:2015 Medical electrical equipment - Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    Edition: 2015
    $569.57
    / user per year

Description of BS EN 60601-2-16:2015 2015

IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 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 60601-2-16:2012 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 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.

Standard NumberBS EN 60601-2-16:2015
TitleMedical electrical equipment - Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
StatusWithdrawn
Publication Date2015-07-31
Withdrawn Date2019-06-14
ReplacesBS EN 60601-2-16:1998
Replaced ByBS EN IEC 60601-2-16:2019, BS EN 60335-2-9:2003+A13:2010
Identical National Standard OfEN 60601-2-16:2015, IEC 60601-2-16:2012
DescriptorsColour codes, Protected electrical equipment, Safety engineering, Identification methods, Current measurement, Warning devices, Electronic equipment and components, Electrical testing, Leak tests, Voltage fluctuations, Watertightness tests, Filtration, Equipment safety, Electrical equipment, Safety measures, Medical equipment, Marking, Artificial kidneys, Ultrafiltration, Dialysis, Haematology, Pumps, Electrical medical equipment, Leakage paths, Alarm systems, Electric shocks, Instructions for use, Electrical safety, Biological filters
ICS11.040.25 Syringes, needles and catheters, 11.040.20 Transfusion, infusion and injection equipment
CommitteeCH/150/2
ISBN978 0 580 78907 6
PublisherBSI
Pages74

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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