BS EN IEC 60601-2-16:2019 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

BS EN IEC 60601-2-16:2019

Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Status : Current   Published : June 2019

Format
HARDCOPY



IEC 60601-2-16:2018 is also available as

IEC 60601-2-16:2018 RLV

which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.



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.




Standard NumberBS EN IEC 60601-2-16:2019
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
StatusCurrent
Publication Date17 June 2019
Normative References(Required to achieve compliance to this standard)EN ISO 3744, ISO 3744, EN 61672-1, EN 60601-1-8:2007/corrigendum Mar. 2010, EN 60601-1-10:2008/A1:2015, EN 60601-1-8:2007, IEC 60601-1-6:2010, EN 60601-1-8:2007/A1:2013/AC:2014, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-8:2006, EN 60601-1-6:2010/A1:2015, IEC 60601-1-11:2015, IEC 60601-1-10:2007, EN 60601-1-8:2007/A1:2013, EN 60601-1-8:2007/A11:2017, IEC 60601-1-8:2006/AMD1:2012, EN 60601-1-11:2015, EN 60601-1-6:2010, EN 60601-1-10:2008, IEC 60601-1-10:2007/AMD1:2013, EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 61672-1
Informative References(Provided for Information)IEC 80001-1:2010, EN 80001-1:2011, EN ISO 14971:2012, ISO 14971:2007, EN ISO 23500-1, CSN EN 14885, ASTM E1153, JIS Z 2801, ISO 8637-1, ISO 23500-2, ISO 23500-5, EN ISO 23500-3, EN 60601-2-39, EN ISO 23500-4, AOAC 964, EN 60601-2-24, ISO 23500-4, IEC 60601-2-24, EN ISO 11197, ISO 23500-1, EN ISO 23500-5, ISO 8637-2, ISO 11197, EN ISO 23500-2, ISO 23500-3, EN ISO 8637-2, ISO 15883, IEC 60601-2-39, IEC PAS 63023, IEC 60601-2-16:1998 (Ed 2)
ReplacesBS EN 60601-2-16:2015
International RelationshipsEN IEC 60601-2-16:2019,IEC 60601-2-16:2018
Draft Superseded By10/30217043 DC16/30323461 DC
DescriptorsBiological filters, Equipment safety, Warning devices, Dialysis, Marking, Electrical medical equipment, Electronic equipment and components, Leak tests, Colour codes, Safety measures, Haematology, Safety engineering, Identification methods, Voltage fluctuations, Filtration, Electrical testing, Electric shocks, Alarm systems, Protected electrical equipment, Current measurement, Pumps, Ultrafiltration, Medical equipment, Electrical equipment, Artificial kidneys, Leakage paths, Instructions for use, Electrical safety, Watertightness tests
ICS11.040.20
11.040.25
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémodialyse, d’hémodiafiltration et d’hémofiltration
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten
CommitteeCH/150/2
ISBN978 0 580 90147 8
PublisherBSI
FormatA4
DeliveryNo
Pages82
File Size1.656 MB
Price£274.00


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