Full Description

This document describes the technical recommendations for use of medical equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles are important to be complied with to ensure safe, permissible and appropriate application.

The term HAEMODIALYSIS is used in this document as synonym for all therapy modalities.

The scope can be applicable to the use of the medical equipment in home, acute and pediatrics environment. The scope may also be applicable to SORBENT DIALYSIS SYSTEMS.

Cross References:
ISO/IEC TS 27008
IEC 80001
IEC 60601-1-11:2015
IEC 60364-7-710:2002
IEC 60601-2-16:2018
ISO 14971:2019
IEC 62353:2014
ISO 23500-5:2019
IEC 60601-1:2005/AMD1:2012
ISO 23500-2:2019
ISO 23500-3:2019
IEC 60601-1:2005
ISO 23500-4:2019
IEC 60309-2:1999
ISO 23500-1:2019
ISO/IEC 27001:2013


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 04/20/2020 ISBN(s): 9780539030143 Number of Pages: 40 File Size: 1 file , 1.4 MB Product Code(s): 30387024, 30387024, 30387024