IEC/TR 62653:2012
(Main)Guidelines for the safe use of medical products in dialysis treatment
Guidelines for the safe use of medical products in dialysis treatment
IEC/TR 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.
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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)
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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
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ICS 11.040.20; 11.040.25 ISBN 978-2-83220-133-6
Warning! Make sure that you obtained this publication from an authorized distributor.
® Registered trademark of the International Electrotechnical Commission
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– 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
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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
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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.
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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.
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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.
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GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS
1 Scope
This 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.
The requirements of IEC 60601-2-16 ensure that equipment used for extracorporeal renal
replacement therapy operates with a high level of safety. Despite that high level of safety,
however, some residual risk remains, related to medical-biological, physical-chemical and
technical HAZARDS. The ORGANIZATION administering the treatment is responsible for managing
the residual risk.
This technical report is not intended to be used as the basis of regulatory inspection or
certification assessment activities.
2 Normative references
None.
NOTE Informative references including IEC and ISO standards are listed in the Bibliography on page 28.
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
NOTE An index of defined terms is found on page 30.
3.1
ACCESSORY
additional part for use with equipment in order to:
– achieve the INTENDED USE,
– adapt it to some special use,
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipment
Note 1 to entry: Accessories can be objects, substances, preparations of substances and software which do not
constitute any medical devices themselves.
[SOURCE: IEC 60601-1:2005, 3.3, modified – a note to entry has been added.]
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TR 62653 © IEC:2012(E) – 7 –
3.2
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,
and post-pump pressure, which is downstream of the blood pump.
[SOURCE: IEC 60601-2-16:2012, 201.3.201]
3.3
BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the
DIALYSER
Note 1 to entry: Not to be mistaken for blood loss to the environment.
[SOURCE: IEC 60601-2-16:2012, 201.3.202, modified – the original note to entry has been
replaced.]
3.4
DIALYSER
a device containing a semi-permeable membrane that is used to perform HAEMODIALYSIS,
HAEMODIAFILTRATION or HAEMOFILTRATION
[SOURCE: IEC 60601-2-16:2012, 201.3.204]
* 3.5
DIALYSIS FLUID
aqueous fluid containing electrolytes and usually buffer and glucose, which is intended to
exchange solutes with blood during HAEMODIALYSIS
Note 1 to entry: The term “DIALYSIS FLUID” is used throughout this document to mean the fluid made from DIALYSIS
WATER and concentrates which is delivered to the DIALYSER by the DIALYSIS FLUID delivery system. Such phrases as
“dialysate”, “dialysis solution” or “dialysing fluid” may be used in place of DIALYSIS FLUID.
Note 2 to entry: The DIALYSIS FLUID entering the DIALYSER is referred to as “fresh DIALYSIS FLUID”, while the fluid
leaving the DIALYSER is referred to as “spent DIALYSIS FLUID”.
Note 3 to entry: DIALYSIS FLUID does not include prepackaged parenteral fluids used in some renal replacement
therapies, such as HAEMODIAFILTRATION and HAEMOFILTRATION.
[SOURCE: ISO 11663:2009, 3.7]
* 3.6
DIALYSIS MACHINE
HAEMODIALYSIS MACHINE
HAEMODIAFILTRATION MACHINE
HAEMOFILTRATION MACHINE
system or combination of units used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or
HAEMOFILTRATION
Note 1 to entry: The DIALYSIS MACHINE can be a batch DIALYSIS MACHINE filled with the entire DIALYSIS FLUID prior
to treatment (see Clause A.6).
Note 2 to entry: The DIALYSIS MACHINE can be supplied with DIALYSIS FLUID from a central DIALYSIS FLUID delivery
system (see Clause A.7).
3.7
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 13959 and which is suitable for
use in HAEMODIALYSIS applications, including the preparation of DIALYSIS FLUID, reprocessing of
DIALYSERS, preparation of concentrates and preparation of substitution fluid for online
convective therapies
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[SOURCE: ISO 13959:2009, 2.5]
3.8
ENCLOSURE
exterior surface of electrical equipment or parts thereof
Note 1 to entry: Including all touchable parts, such as rotary knobs, handles, and the like.
[SOURCE: IEC 60601-1:2005, 3.26, modified – the original note to entry has been replaced.]
* 3.9
EXTRACORPOREAL CIRCUIT
blood lines and any integral ACCESSORY thereof
[SOURCE: IEC 60601-2-16:2012, 201.3.207]
3.10
HAEMODIAFILTRATION
HDF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by a simultaneous
combination of HD and HF
[SOURCE: IEC 60601-2-16:2012, 201.3.208]
3.11
HAEMODIALYSIS
HD
PATIENT's blood and an
process whereby concentrations of water-soluble substances in a
excess of fluid of a PATIENT with renal insufficiency are corrected by bidirectional diffusive
transport and ultrafiltration across a semi-permeable membrane separating the blood from the
DIALYSIS FLUID
Note 1 to entry: Usually, this process includes bidirectional filtration, with fluid removal normally being
predominant.
[SOURCE: IEC 60601-2-16:2012, 201.3.209, modified – the original note to entry has been
replaced.]
3.12
HAEMOFILTRATION
HF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by unidirectional convective
transport via ultrafiltration across a semi-permeable membrane separating the blood from the
ultrafiltrate and ultrafiltrate is simultaneously replaced by an approximately iso-osmolar
substitution fluid at a rate such that the difference between the ultrafiltration rate and the rate
of substitution fluid addition will lead to removal of the excess fluid over the course of the
treatment
[SOURCE: IEC 60601-2-16:2012, 201.3.211, modified – an error has been corrected]
3.13
HAZARD
potential source of harm
[SOURCE: ISO 14971:2007, 2.3]
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TR 62653 © IEC:2012(E) – 9 –
3.14
HAZARDOUS SITUATION
circumstance in which people, property, or the environment are exposed to one or more
HAZARD(S)
[SOURCE: IEC 60601-1:2005, 3.40]
3.15
INCIDENT
malfunction, failure or modification of the features or the performance, or an inadequate or
incorrect labeling or instructions for use of a medical device, which directly or indirectly
resulted in, could have resulted in or might result in the death or a severe deterioration of the
state of health of a patient, an OPERATOR or another person
3.16
INTENDED USE
INTENDED PURPOSE
use for which a product, process or service is intended according to the specifications,
instructions and information provided by the MANUFACTURER
[SOURCE: ISO 14971:2007, 2.5]
3.17
MAINTENANCE
combination of all technical and administrative means, including supervising ones, to keep or
restore a unit in working condition
Note 1 to entry: Unit can be a device or a system.
[SOURCE: IEC 62353:2007, 3.19, modified – a note to entry has been added.]
3.18
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging or labelling
of medical electrical equipment, assembling a medical electrical system, or adapting medical
electrical equipment or a medical electrical system, regardless of whether these operations
are performed by that person or on that person's behalf by a third party
[SOURCE: IEC 60601-1:2005, 3.55, modified – the original notes to entry have been deleted.]
3.19
MODIFICATION
changing constructional or functional features of medical electrical equipment or a medical
electrical system in a way not described in its accompanying documents (instructions for use)
[SOURCE: IEC 62353:2007, 3.23, modified – a note to entry has been deleted and a
reference to instructions for use has been added.]
3.20
OPERATOR
person handling equipment
[SOURCE: IEC 60601-1:2005, 3.73, modified – the original note to entry has been deleted
because not relevant in the context of the present document.]
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3.21
ORGANIZATION
entity of the persons and/or institutions responsible for the use and MAINTENANCE of systems
for extracorporeal renal replacement therapy
EXAMPLES Doctor's office, dialysis center and dialysis clinic.
3.22
PATIENT
living being (person or animal) undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601-1:2005, 3.76]
3.23
PATIENT ENVIRONMENT
any volume in which intentional or unintentional contact can occur between a PATIENT and
parts of the medical electrical equipment or medical electrical system or between a PATIENT
and other persons touching parts of the medical electrical equipment or medical electrical
system
Note 1 to entry: Volume here means room area.
Note 2 to entry: An example of PATIENT ENVIRONMENT is shown in Figure 1.
1,5 m
1,5 m
1,5 m
IEC 2431/05
Figure 1 – Example PATIENT ENVIRONMENT
[SOURCE: IEC 60601-1:2005, 3.79, modified – two notes to entry have been added, including
a figure illustrating the term.]
* 3.24
PATIENT LEAKAGE CURRENT
current coming from an electric device and flowing through the PATIENT to the ground
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TR 62653 © IEC:2012(E) – 11 –
Note 1 to entry: The source of such a current may, for example, be a defective electric heater of the DIALYSIS
MACHINE. The current may be transmitted through the conducting DIALYSIS FLUID and to the PATIENT.
[SOURCE: IEC 60601-1:2005, 3.80, modified – definition simplified and a note to entry has
been added.]
3.25
POTENTIAL EQUALIZATION CONDUCTOR
conductor other than a protective earth conductor or a neutral conductor, providing a direct
connection between electrical equipment and the potential equalization busbar of the
electrical installation
[SOURCE: IEC 60601-1:2005, 3.86]
3.26
PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDS which can arise
[SOURCE: IEC 60601-2-16:2012, 201.3.215]
3.27
REPAIR
means for reconstitution of a defined condition
[SOURCE: IEC 62353:2007, 3.35]
3.28
SERVICING
combination of all means for maintaining the medical electrical equipment or medical
electrical system within requirements of the MANUFACTURER
[SOURCE: IEC 62353, 3.37]
3.29
SORBENT DIALYSIS SYSTEM
method of dialysis where DIALYSIS FLUID is generated from potable water and spent DIALYSIS
FLUID is regenerated into fresh DIALYSIS FLUID by recirculation through a sorbent cartridge
which removes uremic toxins from the DIALYSIS FLUID while replenishing other beneficial
chemicals
* 3.30
TOUCH CURRENT
current not necessary for proper functioning, coming from the ENCLOSURE or parts thereof
(except PATIENT connectors), which the OPERATOR or PATIENT may touch while using the
equipment as intended and flowing to the ground or another part of the ENCLOSURE after
having passed through an external connection (except the protective earth conductor)
3.31
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT
[SOURCE: IEC 60601-2-16:2012, 201.3.219]
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4 Requirements
4.1 Personnel, qualification
OPERATORS should be qualified and have received the appropriate training for the activities
assigned to them, including the operation of all medical devices and associated disposables
and supplies.
If treatment is undertaken at home, the PATIENT and/or the person taking care of the PATIENT
should also be appropriately trained not only in the operation of the medical device, but also
in the procedures that should be followed in the event of an INCIDENT arising from the use of
the equipment.
4.2 Training
OPERATORS/PATIENTS should be trained for the activity assigned to them:
a) The ORGANIZATION should only assign persons who have been trained in the INTENDED USE
of the devices that they will operate (see 7.3). Particular attention should be paid to the
OPERATOR´s responsibility in following the instructions for use, the warnings and
precautions outlined by the MANUFACTURER.
b) The training should be based on the valid instructions for use and include any unit
protocols, including actions or interventions needed in case of alarms, cautions, or
equipment failure. The instructions for use should be available at any time.
c) Only ORGANIZATIONS who have received training from the MANUFACTURER can develop a
training program to train additional personnel within that ORGANIZATION to operate the
devices.
d) The ORGANIZATION should develop training material that ensures a comprehensive,
structured training program to include 1) training outline, 2) goals and objectives, 3)
maximum number of trainees, 4) duration of training program for the staff of the
ORGANIZATION.
e) The training program for PATIENTS should include but not be limited to: techniques
associated with the specific modality, prescription, effective administration of medications,
how to detect, report, and manage dialysis complications both medical and non-medical.
f) If MODIFICATIONS by the MANUFACTURER become necessary, the MANUFACTURER decides to
what extent an additional training guided by the MANUFACTURER is necessary.
g) The completion of any training programme should be documented by the ORGANIZATION.
The systems should be operated according to the MANUFACTURER’S instructions and based on
the knowledge and skills required for the particular medical treatment. These application
principles and/or any brief operating instructions do not replace the detailed instructions for
use or a qualified training in the handling of the systems.
4.3 Infrastructure
4.3.1 General
Safe performance of an extracorporeal renal replacement therapy requires that all
components of the system work harmoniously as intended; the systems should be used in the
appropriate rooms and drugs and medical devices should be within specified tolerances.
DIALYSIS MACHINES are provided with PROTECTIVE SYSTEMS (e.g. for monitoring the conductivity,
the temperature of the DIALYSIS FLUID and the VENOUS PRESSURE as well as for detecting BLOO
...
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