IEC TR 62653:2012
(Main)Guideline for safe operation of medical equipment used for haemodialysis treatments
Guideline for safe operation of medical equipment used for haemodialysis treatments
IEC 62653:2012(E) which is a technical report, describes the technical requirements for use of equipment in haemodialysis, haemofiltration and haemodiafiltration. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the haemodialysis treatment prescription. However, the organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. If applicable, the scope may be applicable to the use of the equipment in paediatrics, home haemodialysis, acute and sorbent dialysis systems. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
General Information
Relations
Standards Content (Sample)
IEC/TR 62653 ®
Edition 1.0 2012-06
TECHNICAL
REPORT
Guideline for safe operation of medical equipment used for haemodialysis
treatments
IEC/TR 62653:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.
IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: csc@iec.ch.
IEC/TR 62653 ®
Edition 1.0 2012-06
TECHNICAL
REPORT
Guideline for safe operation of medical equipment used for haemodialysis
treatments
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
U
ICS 11.040.20; 11.040.25 ISBN 978-2-83220-133-6
– 2 – TR 62653 © IEC:2012(E)
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 12
4.1 Personnel, qualification . 12
4.2 Training . 12
4.3 Infrastructure . 12
4.3.1 General . 12
4.3.2 Infrastructure requirements . 13
5 Treatment . 15
5.1 General . 15
5.2 Preparation . 15
5.2.1 DIALYSIS MACHINE . 15
5.2.2 * DIALYSIS FLUID PREPARATION . 15
5.2.3 * EXTRACORPOREAL CIRCUIT . 16
5.2.4 DIALYSIS FLUID compartment . 16
5.2.5 PATIENT . 16
5.3 Treatment . 17
5.3.1 Preparing the vascular access . 17
5.3.2 * Connection to the EXTRACORPOREAL CIRCUIT . 17
5.3.3 Initiation of treatment . 17
5.3.4 Checks to be repeated during the treatment . 18
5.3.5 * HAZARDS during the treatment . 19
5.3.6 Deviations from the treatment parameters prescribed or treatment
interruption . 19
5.3.7 Terminating the DIALYSIS treatment . 20
5.3.8 * After completion of the dialysis treatment . 20
6 Notification of INCIDENTS . 20
7 Handling medical devices . 20
7.1 Technical service, SERVICING and checks of equipment and plants . 20
7.2 * Equipment safety and device combinations . 21
7.3 Non-INTENDED USE . 21
Annex A (informative) Explanatory technical remarks . 22
Bibliography . 28
Index of defined terms used in this guideline. 30
Figure 1 – Example PATIENT ENVIRONMENT . 10
Figure A.1 – Typical central DIALYSIS FLUID delivery system, CDDS . 26
TR 62653 © IEC:2012(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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 62653, which is a technical report, has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62D/976/DTR 62D/1006/RVC
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.
– 4 – TR 62653 © IEC:2012(E)
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The verbal forms used in this guideline are conform to usage described in Annex H of the
ISO/IEC Directives, Part 2, 2011.
For the purpose of this informative guideline the auxiliary verb ”should“ means that this
statement of the guideline is recommended for safe operation. This term is not to be
interpreted as indicating requirements.
In this guideline the following print types are used:
– Requirements and definitions: roman type;
– Informative material, such as notes, examples and references: smaller type;
– TERMS DEFINED IN THIS GUIDELINE OR AS NOTED: SMALL CAPITALS.
An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that
there is guidance or rationale related to that item in Annex A.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.
TR 62653 © IEC:2012(E) – 5 –
INTRODUCTION
HAEMODIALYSIS is a therapeutic method for treating terminal renal insufficiency, in addition to
peritoneal dialysis and renal transplantation. HAEMODIALYSIS is often used as a general term
for related extracorporeal methods of renal replacement therapy. At present, HAEMODIALYSIS is
a standard procedure in renal replacement therapy, which, when applied properly, yields high-
quality results. The treatment is a complex procedure which is under the influence of medical-
biological, physical-chemical and technical processes.
Numerous guidelines, agreements, codes, decrees and laws have been established with
regard to HAEMODIALYSIS. They contain detailed regulations about the quality of structures,
processes and results, laid down by the legislative body, executive bodies of self-government,
and funding agencies.
Since the safety of PATIENT treatment and the legal provisions are highly important, it is
reasonable to introduce a quality management system. This technical report may be an
integral part of a quality management system of the ORGANIZATION. The ORGANIZATION should
identify the residual risks, for example based on these guidelines. The ORGANIZATION should
minimise such risks by the use of appropriate standard operating procedures. This document
is intended to support the clinical management responsible for the quality management of
HAEMODIALYSIS therapies.
------------------
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.