Full Description

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.

This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.

This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision.

This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS,HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location.

If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for otherextracorporeal blood purification treatments.

Cross References:
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
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)


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

Product Details

Published: 06/17/2019 ISBN(s): 9780580901478 Number of Pages: 82 File Size: 1 file , 1.8 MB Product Code(s): 30323462, 30323462, 30323462 Note: This product is unavailable in United Kingdom