IEC TR 62653:2020

IEC TR 62653 ®
Edition 2.0 2020-04
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Guideline for safe operation of medical equipment used for haemodialysis
treatments
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IEC TR 62653 ®
Edition 2.0 2020-04
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Guideline for safe operation of medical equipment used for haemodialysis

treatments
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.20; 11.040.25 ISBN 978-2-8322-8235-9

– 2 – IEC TR 62653:2020 RLV © IEC:2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Requirements Recommendations . 15
4.1 Personnel, qualification . 15
4.2 Training . 15
4.3 Infrastructure . 15
4.3.1 General . 15
4.3.2 Infrastructure requirements recommendation . 16
5 Treatment . 19
5.1 General . 19
5.2 Preparation . 19
5.2.1 DIALYSIS MACHINE . 19
5.2.2 * DIALYSIS FLUID preparation by DIALYSIS MACHINE . 19
5.2.3 * EXTRACORPOREAL CIRCUIT . 20
5.2.4 DIALYSIS FLUID compartment . 20
5.2.5 PATIENT . 20
5.3 Treatment . 21
5.3.1 Preparing the vascular access . 21
5.3.2 * Connection to the EXTRACORPOREAL CIRCUIT . 21
5.3.3 Initiation of treatment . 22
5.3.4 Checks to be repeated during the treatment . 22
5.3.5 * HAZARDS during the treatment . 23
5.3.6 Deviations from the prescribed treatment parameters prescribed or
treatment interruption . 24
5.3.7 Terminating the DIALYSIS treatment . 24
5.3.8 * After completion of the dialysis treatment . 25
6 Notification of INCIDENTS . 25
7 Handling medical electrical equipment and medical devices . 26
7.1 Technical service, SERVICING and checks of medical electrical equipment and
plants infrastructure . 26
7.2 * Medical electrical equipment safety and device medical electrical
equipment combinations . 26
7.3 Non-INTENDED USE . 27
Annex A (informative) Explanatory technical remarks . 28
A.1 Overview. 28
A.2 DIALYSIS FLUID . 28
A.3 Blood loss to the environment . 29
A.4 Air infusion. 30
A.5 Electrical safety . 30
A.6 Proportioning type and batch DIALYSIS MACHINEs . 31
A.7 CENTRAL DIALYSIS FLUID DELIVERY SYSTEM (CDDS) . 32
A.8 Microbiological contamination of the DIALYSIS FLUID . 33
A.9 Bloodline INTENDED USE and potential risks . 33

Bibliography . 35
Index of defined terms used in this document . 39

Figure 1 – Example PATIENT ENVIRONMENT . 13
Figure A.1 – Typical CENTRAL DIALYSIS FLUID DELIVERY SYSTEM (CDDS) . 33

– 4 – IEC TR 62653:2020 RLV © IEC:2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS

FOREWORD
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The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC TR 62653, which is a technical report, has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 2012. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) update the relevant references to the new numbering scheme of the ISO 23500 family;
b) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 62353:2014
and 60601-2-16:2018;
c) technical additions in several sections.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62D/1698/DTR 62D/1744/RVDTR
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
The verbal forms used in this document are conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2, 2018.
For the purpose of this document, the auxiliary verb “should” means that this statement of the
document is recommended for safe operation. This term is not to be interpreted as indicating
requirements.
In this document the following print types are used:
– requirements and definitions: roman type;
– informative mater
...