IEC 60601-2-16:2018 + Redline

IEC 60601-2-16:2018 + Redline

IEC 60601-2-16:2018 (Redline version) Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

516,00 €

Detalles

IEC 60601-2-16:2018 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its 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.

Información adicional

Autor International Electrotechnical Commission (IEC)
Comité TC 62/SC 62D
Publicado por IEC
Tipo de Documento Norma
Edición 5.0
ICS 11.040.20 : Equipo de transfusión, infusión e inyección
11.040.25 : Jeringas, agujas y catéteres
Número de páginas 236
Palabra clave IEC60601-2-16,IEC 60601-2-16:2018 RLV,IEC 60601-2-16,TC 62/SC 62D
Formulario de pedido