BS EN IEC 60601-2-39:2019 - Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

BS EN IEC 60601-2-39:2019

Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Status : Current   Published : August 2019

Format
PDF

Format
HARDCOPY



IEC 60601-2-39:2018 is also available as

IEC 60601-2-39:2018 RLV

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



IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition:


- update of the 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 and of references and requirements to IEC 60601-1-11:2015;


- editorial improvements;


- improvement of the essential performance requirements clause/subclauses;


- new requirements for the interruption of the power supply.




Standard NumberBS EN IEC 60601-2-39:2019
TitleMedical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
StatusCurrent
Publication Date14 August 2019
Normative References(Required to achieve compliance to this standard)IEC 60601-1-2:2014, IEC 60601-1-8:2006, IEC 60601-1-11:2015, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-6:2010
Informative References(Provided for Information)IEC 60601-1-9:2007/AMD1:2013, ISO 80369-1:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-6:2010, IEC 60601-1-10:2007, IEC 60601-1-9:2007, IEC 60601-1-10:2007/AMD1:2013
ReplacesBS EN 60601-2-39:2008+A11:2011
International RelationshipsEN IEC 60601-2-39:2019,IEC 60601-2-39:2018
Draft Superseded By16/30323465 DC
DescriptorsTemperature control, Testing conditions, Leak tests, Instructions for use, Leakage currents, Safety engineering, Artificial kidneys, Electronic equipment and components, Electrical equipment, Equipment safety, Safety measures, Current measurement, Dialysis, Liquids, Electrical safety, Pressure, Electric shocks, Medical equipment, Electrical medical equipment, Technical documents, Pumps
ICS11.040.99
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
CommitteeCH/150/2
ISBN978 0 580 90148 5
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size1.055 MB
Price£214.00


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