IEC TR 62653:2020
(Main)Guideline for safe operation of medical equipment used for haemodialysis treatments
Guideline for safe operation of medical equipment used for haemodialysis treatments
IEC TR 62653:2020 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.
The physician is responsible for the 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. The requirements of IEC 60601-2-16 ensure that medical electrical 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 document is not intended to be used as the basis of regulatory inspection or certification assessment activities. IEC TR 62653:2020 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.
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IEC TR 62653 ®
Edition 2.0 2020-04
TECHNICAL
REPORT
Guideline for safe operation of medical equipment used for haemodialysis
treatments
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IEC TR 62653 ®
Edition 2.0 2020-04
TECHNICAL
REPORT
Guideline for safe operation of medical equipment used for haemodialysis
treatments
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.20; 11.040.25 ISBN 978-2-8322-8143-7
– 2 – IEC TR 62653:2020 © IEC:2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Recommendations . 13
4.1 Personnel, qualification . 13
4.2 Training . 13
4.3 Infrastructure . 14
4.3.1 General . 14
4.3.2 Infrastructure recommendations . 14
5 Treatment . 17
5.1 General . 17
5.2 Preparation . 17
5.2.1 DIALYSIS MACHINE . 17
5.2.2 DIALYSIS FLUID preparation by DIALYSIS MACHINE . 18
5.2.3 EXTRACORPOREAL CIRCUIT . 18
5.2.4 DIALYSIS FLUID compartment . 19
5.2.5 PATIENT . 19
5.3 Treatment . 19
5.3.1 Preparing the vascular access . 19
5.3.2 Connection to the EXTRACORPOREAL CIRCUIT . 20
5.3.3 Initiation of treatment . 20
5.3.4 Checks to be repeated during the treatment . 21
5.3.5 HAZARDS during the treatment . 22
5.3.6 Deviations from the prescribed treatment parameters . 23
5.3.7 Terminating the DIALYSIS treatment . 23
5.3.8 After completion of the dialysis treatment . 23
6 Notification of INCIDENTS . 23
7 Handling medical electrical equipment and medical devices . 24
7.1 Technical service, SERVICING and checks of medical electrical equipment and
infrastructure . 24
7.2 Medical electrical equipment safety and medical electrical equipment
combinations . 24
7.3 Non-INTENDED USE . 25
Annex A (informative) Explanatory technical remarks . 26
A.1 Overview. 26
A.2 DIALYSIS FLUID . 26
A.3 Blood loss to the environment . 27
A.4 Air infusion. 28
A.5 Electrical safety . 28
A.6 Proportioning type and batch DIALYSIS MACHINEs . 29
A.7 CENTRAL DIALYSIS FLUID DELIVERY SYSTEM (CDDS) . 30
A.8 Microbiological contamination of the DIALYSIS FLUID . 30
A.9 Bloodline INTENDED USE and potential risks . 31
Bibliography . 32
Index of defined terms used in this document . 36
Figure 1 – Example PATIENT ENVIRONMENT . 12
Figure A.1 – Typical CENTRAL DIALYSIS FLUID DELIVERY SYSTEM (CDDS) . 30
– 4 – IEC TR 62653:2020 © IEC:2020
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
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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 material, such as notes, examples and references: smaller type;
– TERMS DEFINED IN CLAUSE 3 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 document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – IEC TR 62653:2020 © IEC:2020
INTRODUCTION
HAEMODIALYSIS is a therapeutic method for treating 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 document may be an integral part
of a quality management system of the ORGANIZATION. The ORGANIZATION should be aware of
the residual risks and identify appropriate measures, 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.
GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS
1 Scope
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.
The physician is responsible for the 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.
The requirements of IEC 60601-2-16 ensure that medical electrical 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 document is not intended to be used as the basis of regulatory inspection or certification
assessment activities.
2 Normative references
There are no normative references in this document.
NOTE Informative references including IEC and ISO standards are listed in the Bibliography starting on page 32.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 36.
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,
– 8 – IEC TR 62653:2020 © IEC:2020
– 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 equipment themselves.
[SOURCE: IEC 60601-1:2005, 3.3, modified – A note to entry has been added.]
3.2
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT between the
PATIENT connection and DIALYSER connection
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump
(typically negative), and post-pump pressure (typical positive), which is downstream of the blood pump.
[SOURCE: IEC 60601-2-16:2018, 201.3.201, modified – Direction of pressure added.]
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 60601-2-16:2018, 201.3.202, modified – The original note to entry has been
replaced.]
3.4
CENTRAL CONCENTRATE SYSTEM
system that prepares and/or stores concentrate at a central point for subsequent distribution
to its points of use
3.5
CENTRAL DIALYSIS FLUID DELIVERY SYSTEM
system that produces DIALYSIS FLUID from DIALYSIS WATER and concentrate or powder at a
central point and distributes the DIALYSIS FLUID from the central point to individual dialysis
consoles
3.6
DIALYSER
HAEMODIALYSIS,
device containing a semi-permeable membrane that is used to perform
HAEMODIAFILTRATION or HAEMOFILTRATION
[SOURCE: IEC 60601-2-16:2018, 201.3.204]
3.7
DIALYSIS FLUID
aqueous fluid containing electrolytes and usually buffer and glucose, which is intended to
HAEMODIALYSIS and HEMODIAFILTRATION
exchange solutes with blood during
Note 1 to entry: The term “DIALYSIS FLUID” is used throughout this document to mean the fluid made from DIALYSIS
WATER and concentrates that is delivered to the DIALYSER by the DIALYSIS FLUID delivery system. Such phrases as
“dialysate” or “dialysis solution” are used in place of DIALYSIS FLUID in some countries; however, that usage is
discouraged to avoid confusion.
Note 2 to entry: ISO 23500-5 defines three levels of DIALYSIS FLUID: standard DIALYSIS FLUID, ultrapure DIALYSIS
FLUID, and online-prepared substitution fluid used for HAEMODIAFILTRATION.
Note 3 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 4 to entry: DIALYSIS FLUID does not include prepackaged parenteral fluids used in some renal replacement
therapies, such as HAEMODIAFILTRATION and HAEMOFILTRATION.
[SOURCE: ISO 23500-1:2019, 3.15, modified – The terms "dialysate" and "dialysis solution"
were deleted.]
3.8
DIALYSIS MACHINE
HAEMODIALYSIS MACHINE
HAEMODIAFILTRATION MACHINE
HAEMOFILTRATION MACHINE
medical electrical equipment 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 A.6).
Note 2 to entry: The DIALYSIS MACHINE can be supplied with DIALYSIS FLUID from a CENTRAL DIALYSIS FLUID
DELIVERY SYSTEM and synonymously named individual dialysis console in this context (see A.7).
3.9
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 23500-3 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
[SOURCE: ISO 23500-1:2019, 3.17]
3.10
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.]
3.11
EXTRACORPOREAL CIRCUIT
blood lines, DIALYSER and any integral ACCESSORY
[SOURCE: IEC 60601-2-16:2018, 201.3.207, modified – Deletion of Note to entry.]
3.12
HAEMODIAFILTRATION
HDF
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT are corrected by a simultaneous combination of HD and HF
[SOURCE: IEC 60601-2-16:2018, 201.3.208]
3.13
HAEMODIALYSIS
HD
process whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT are corrected by bidirectional diffusive transport and ultrafiltration
across a semi-permeable membrane separating the blood from the DIALYSIS FLUID
Note 1 to entry: This process typically includes fluid removal by filtration. This process is usually also
accompanied by diffusion of substances from the DIALYSIS FLUID into the blood.
– 10 – IEC TR 62653:2020 © IEC:2020
[SOURCE: IEC 60601-2-16:2018, 201.3.209]
3.14
HAEMOFILTRATION
HF
process whereby concentrations of water-soluble substances in a PATIENT'S blood and an
PATIENT are corrected by convective transport via ultrafiltration and partial
excess of fluid of a
replacement by a substitution fluid resulting in the required net fluid removal
[SOURCE: IEC 60601-2-16:2018, 201.3.211]
3.15
HAZARD
potential source of harm
[SOURCE: ISO 14971:2019, 3.4]
3.16
HAZARDOUS SITUATION
circumstance in which people, property, or the environment are exposed to one or more
HAZARD(S)
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.40]
3.17
INCIDENT
malfunction, failure or MODIFICATION of the features or the performance, or an inadequate or
incorrect labeling or instructions for use of a medical equipment, 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
3.18
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 14971:2019, 3.6, modified – Deletion of the Note.]
3.19
MAINTENANCE
combination of all technical and administrative means, including supervising ones, to keep
medical electrical equipment or a medical electrical system in a normal working condition or
restored to normal working condition
[SOURCE: IEC 62353:2014, 3.21]
3.20
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging or labelling
of medical equipment, assembling a medical system, or adapting medical equipment or a
medical system, regardless of whether these operations are performed by that person or on
that person's behalf by a third party
Note 1 to entry: In the context of this document the term medical equipment is used as umbrella term for medical
electrical equipment and non-active medical devices.
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.55, modified – The original notes to entry have
been deleted.]
3.21
MODIFICATION
changing constructional or functional features of medical equipment or a medical system in a
way not described in its instruction for use or other accompanying documents
[SOURCE: IEC 62353:2014, 3.25, modified – A note to entry has been deleted and a
reference to instructions for use has been added.]
3.22
OPERATOR
person handling equipment
[SOURCE: IEC 60601-1:2005, 3.73, modified – The original note to entry has been deleted]
3.23
ORGANIZATION
entity of the persons and/or institutions responsible for the application and MAINTENANCE of
systems for extracorporeal renal replacement therapy
EXAMPLES Medical doctors, dialysis centers and dialysis clinics and their responsible parties.
3.24
PATIENT
living being (person or animal) undergoing a medical, surgical or dental procedure
Note 1 to entry: A PATIENT can be an OPERATOR.
Note 2 to entry: For the purpose of this document PATIENT is a human being
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.76, modified – Addition of a new Note 2 to
entry.]
3.25
PATIENT ENVIRONMENT
any volume in which intentional or unintentional contact can occur between a PATIENT and
PATIENT
parts of the medical electrical equipment or medical electrical system or between a
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.
– 12 – IEC TR 62653:2020 © IEC:2020
Dimensions in metres
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.]
3.26
PATIENT LEAKAGE CURRENT
current coming from a medical electric equipment and flowing through the PATIENT to the
ground
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.
3.27
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, modified – Note deleted.]
3.28
PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDOUS SITUATIONS
[SOURCE: IEC 60601-2-16:2018, 201.3.215]
3.29
REPAIR
means for restoring to a safe, functional, normal condition
[SOURCE: IEC 62353:2014, 3.39]
3.30
SERVICING
combination of all means for maintaining the medical electrical equipment or medical
electrical system within requirements of the MANUFACTURER
[SOURCE: IEC 62353:2014, 3.41]
3.31
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
3.32
TOUCH CURRENT
current not necessary for appropriate functioning, coming from the ENCLOSURE or parts thereof
(except PATIENT connectors), which the OPERATOR or PATIENT may touch while using the
medical electrical 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)
3.33
TRANSMEMBRANE PRESSURE
TMP
fluid pressure difference exerted across the semi-permeable membrane of the DIALYSER
Note 1 to entry: Generally, the mean TMP is used. In practice, the displayed TRANSMEMBRANE PRESSURE is usually
estimated from the measured EXTRACORPOREAL CIRCUIT pressure minus the measured DIALYSIS FLUID pressure,
each obtained at a single point.
[SOURCE: IEC 60601-2-16:2018, 201.3.217]
3.34
VENOUS PRESSURE
EXTRACORPOREAL CIRCUIT between the
pressure measured in the blood return line of the
DIALYSER connection and PATIENT connection (typically positive)
[SOURCE: IEC 60601-2-16:2018, 201.3.219, modified – Direction of pressure added]
4 Recommendations
4.1 Personnel, qualification
OPERATORS should be qualified and have received the appropriate training for the activities
assigned to them, including the operation of the medical electrical equipment, medical
devices, ACCESSORIES 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 electrical
equipment, medical devices, but also in the procedures that should be followed in the event of
an INCIDENT arising from the use of the medical equipment.
4.2 Training
OPERATORS/PATIENTS should be trained for the activity assigned to them:
– 14 – IEC TR 62653:2020 © IEC:2020
a) The ORGANIZATION should only assign persons who have been trained in the INTENDED USE
of the medical electrical equipment, medical devices or systems 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 MANUFACTURERS,
because these instructions are crucial to avoid remaining / residual risks not technically
mitigated by the medical equipment themselves.
b) The training should be based on the valid instructions for use and include any unit
protocols, actions or interventions needed in case of alarms, cautions, or medical
equipment failure. The instructions for use should be available at any time.
c) Only ORGANIZATIONS that have received training from the MANUFACTURERS of the medical
electrical equipment or system can develop a training program to train additional
personnel within that ORGANIZATION to operate the medical electrical equipment or system.
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, modality prescription, administration of medications
and procedures for the detection, reporting and management of both medical and non-
medical complications arising from the treatment.
f) If MODIFICATIONS by the MANUFACTURER are necessary, the MANUFACTURER should provide
written documentation regarding the MODIFICATIONS undertaken. If necessary, the
MANUFACTURER should also provide appropriate additional training.
ORGANIZATION.
g) The completion of any training program should be documented by the
h) The medical electrical equipment, medical devices or systems should be operated in
accordance 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 medical equipment or
systems.
4.3 Infrastructure
4.3.1 General
Safe performance of an extracorporeal renal replacement therapy requires that all
components of the system work as intended; the systems should be used in the appropriate
rooms and drugs (e.g. pre-manufactured fluid bags) and medical equipment should be used
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 BLOOD LEAKS and air in the EXTRACORPOREAL CIRCUIT). Such
PROTECTIVE SYSTEMS may be subject to damage and should, therefore, be checked for
appropriate functioning at regular intervals according to the MANUFACTURER’S instructions.
Failure to complete checks according to the MANUFACTURER’S instructions places the PATIENT
at risk, and technical advice prior to the commencement of the treatment should be sought.
4.3.2 Infrastructure recommendations
4.3.2.1 Technical recommendations in rooms
Rooms, except rooms in the home healthcare environment, which are intended for
employment of HAEMODIALYSIS systems according to IEC 60601-1 are medically used rooms of
Group 1 as defined in IEC 60364-7-710.
The electric connection of a DIALYSIS MACHINE of class I should be established by a socket
outlet with tested grounding by protective earth and a plug which cannot be mistaken for other
socket outlets. Use of adaptors or extension cords, not approved by the MANUFACTURER of the
medical electrical equipment, with grounded machines could lead to electrical safety HAZARDS.
The treatment location should be provided with an additional potential equalization connector
tested according to IEC 60364-7-710, (see 710.413.1.6, additional potential equalization, of
IEC 60364-7-710:2002). If central venous catheters whose tip is in the right atrium are used
for the vascular access, special measures might be necessary for complying with electrical
safety requirements [13], [14], [15], [16]. The MANUFACTURER´S instructions should be
followed.
Possible examples are: socket outlets and plugs according to IEC 60309-2, colour code
identification of the power socket dedicated to the machine. Power cord and plugs should be
according to MANUFACTURER´s instructions.
If an emergency occurs during the dialysis treatment, it should be possible to alert the person
taking care of the PATIENTS and or emergency medical services.
In order to prevent the DIALYSIS MACHINE from being contaminated with viruses, bacteria,
endotoxins and fungi by retroactive effect from the drain, the medical electrical equipment
MANUFACTURER’S instructions in the instructions for use should be followed for installation of
the drain tube.
In addition, it is recommended that drains intended to discharge the spent DIALYSIS FLUID be
provided with a stench trap.
Handling of waste liquids to the drain should comply with the local regulations.
If conditions are unfavorable, e.g. in case of backflow, the DIALYSIS MACHINE might become
contaminated. To prevent this, the minimum distance of the drain opening from the level of
the sewage water should not be less than 2 cm or according to the MANUFACTURER’S
specification or according to local regulations.
4.3.2.2 Water treatment and distribution
ISO 23500-2 should be taken as reference.
4.3.2.3 Concentrate supply
ISO 23500-4 should be taken as reference.
4.3.2.4 Responsibilities for on-site preparation of fluids
ISO 23500-1 should be taken as reference.
4.3.2.5 Infection control
Each ORGANIZATION should have in place an infection control policy for the protection of
PATIENTS and personnel [1], [2]. This policy should be dated, with its review date clearly
indicated.
The infection control policy should include specifications of how to manage both sterile
supplies and handling techniques.
The infection control policy should include specifications for prevention and control of blood
borne virus infection in PATIENTS and staff. If treatment is performed away from the normal
PATIENTS, support workers,
treatment location (hospital/home) the measures needed to protect
and others from the risk of blood-borne virus infections should be outlined.
—————————
Numbers in square brackets refer to the Bibliography.
– 16 – IEC TR 62653:2020 © IEC:2020
Correct handling techniques typically include:
• hand hygiene,
• use of gloves and other protective equipment,
• use of face masks,
• technique for preparation of supplies to be used during the treatment,
• use of materials within use-by dates,
• technique for access preparation and access care,
• technique for blood and fluid connections,
• waste disposal,
• used disinfection methods.
In addition, the infection control policy should describe the management of cleaning and
MANUFACTURER's instructions
disinfecting equipment and environmental services according to
and country specific regulations.
When the fluid pathways of DIALYSIS MACHINES are disinfected, the MANUFACTURER’s
instructions should be followed.
The infection control policy should include the disinfectant to be used for surface
disinfections, the required concentration and the minimum exposure time required by the
disinfecting agent in terms of bactericidal efficacy and inactivation of bloodborne viruses such
as HBV, HCV and HIV. Since surface disinfectants may damage the materials of the device,
MANUFACTURER’S recommendations should be taken into account.
If the infection status of PATIENTS is unknown with regard to blood-borne virus infections, the
appropriate measures should be taken to exclude any contamination of other PATIENTS.
Special measures are required for PATIENTS with virus infection transferred by blood according
to country regulations [2], [3], [4].
Measures for the return of DIALYSIS MACHINES used on PATIENTS with blood-borne virus
infections to a non-infectious area are, for example, described in “Guideline for Applied
Hygiene in Dialysis – In German” [1] or local Infection Control Policies.
4.3.2.6 Other prerequisites
To assure compatibility of medical equipment and ACCESSORIES comprising the system, the
INTENDED USES and compatibilities of the medical equipment found in the instructions for use
should be taken into account.
4.3.2.7 Home HAEMODIALYSIS recommendations
If the DIALYSIS MACHINE and associated water treatment equipment are used in the PATIENT’S
MANUFACTURER should be followed. To comply with
home, the requirements specified by the
local requirements, it may additionally be necessary for the installation to be examined by an
approved expert to ensure that the quality of the alterations meets the requirements specified
by the MANUFACTURER of the DIALYSIS MACHINE and by the MANUFACTURER of the water
treatment and/or DIALYSIS FLUID preparation equipment.
It is recommended that home HAEMODIALYSIS PATIENTS have a communication equipment to
ORGANIZATION in the event of a medical emergency and a
permit contact with the supervising
backup communication equipment in case of malfunction of the first communication
equipment.
It is recommended that the room used for HAEMODIALYSIS contains emergency lighting
equipment such a flashlight or torch to provide illumination in the event of a power failure.
The PATIENT or carer should also be appropriately trained as to what procedures to follow in
the event of a mains power failure.
It is recommended that initial and periodic assessment of the home environment be performed
to ensure that it meets the necessary technical and operational requirements; physical space,
plumbing requirements, water requirements, electrical requirements, storage and waste
management, and documentation.
NOTE The considerations in Annex F of ISO 23500-1:2019 and in IEC 60601-1-11 are important to be taken into
account.
4.3.2.8 Information technology (IT) management
There is widespread utilization of IT technology in hospitals or provided by third parties, and
in many dialysis units the DIALYSIS MACHINES can also be linked to such infrastructures, whilst
for home HAEMODIALYSIS PATIENTS there may be a linkage to remote monitoring infrastructures
that may be operated by third parties rather than the hospital. The use of IT infrastructures
poses two issues: safety of the PATIENT, and data protection.
It is recommended for the ORGANIZATION to follow the standards below in dealing with above
issues:
• IEC 80001 (all parts), Application of risk management for IT-networks incorporating
medical devices;
• ISO/IEC 27001, Information technology – Security techniques – Information security
management systems – Requirements;
• ISO/IEC TS 27008, Information technology – Security techniques – Guidelines for the
assessment of information security controls.
IT risk management should be established from the beginning and subject to continuous
review. Technical and organizational security measures [23] cannot be treated casually in
either a hospital or an office setting; there need to be defined objectives, safeguards and
responsibilities as well as defined policies well-known to all staff members. IT security should
be checked regularly, including existing work routines to ensure that they are suitable and
efficient.
5 Treatment
5.1 General
HAEMODIALYSIS treatment should be carried out by qualified OPERATORS under the
The
physician’s responsibility. The physician determines the prescription of the HAEMODIALYSIS
treatment, e.g. dialysis time, treatment frequency, DIALYSER, composition of the DIALYSIS FLUID,
blood flow, DIALYSIS FLUID temperature, anticoagulation if needed, and ultrafiltration rate or
ultrafiltration volume. The OPERATOR should only use information on DIALYSIS MACHINE displays
for its INTENDED USE. The OPERATOR should use information provided by the DIALYSIS MACHINE only in
INTENDED USE by the MANUFACTURER.
the way described as
5.2 Preparation
5.2.1 DIALYSIS MACHINE
Before the dialysis treatment the DIALYSIS MACHINE should be checked for correct connections
POTENTIAL EQUALIZATION CONDUCTOR, water, concentrate or DIALYSIS FLUID
(e.g. power supply,
supply as well as fluid drain).
If local check lists exist, they should be followed.
– 18 – IEC TR 62653:2020 © IEC:2020
The DIALYSIS MACHINE should be disinfected according to the MANUFACTURER´s instructions and
checked for residual disinfectant if necessary. In the case of a malfunction of the disinfection
program or if the OPERATOR is in doubt whether disinfection was completed properly, the
procedure should be repeated, or the DIALYSIS MACHINE should be disabled until checked by a
technician.
NOTE 1 In case of prolonged downtime
...
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
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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 material, such as notes, examples and references: smaller type;
– TERMS DEFINED IN CLAUSE 3 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.
– 6 – IEC TR 62653:2020 RLV © IEC:2020
The committee has decided that the contents of this document will remain unchanged until the
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the specific document. At this date, the document will be
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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 document may be an integral part
of a quality management system of the ORGANIZATION. The ORGANIZATION should identify be
aware of the residual risks and identify appropriate measures, 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.
– 8 – IEC TR 62653:2020 RLV © IEC:2020
GUIDELINE FOR SAFE OPERATION OF MEDICAL
EQUIPMENT USED FOR HAEMODIALYSIS TREATMENTS
1 Scope
This document describes the technical requirements recommendations for use of medical
equipment in chronic HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These
principles should are important to be complied with to ensure safe, permissible and proper
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.
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 medical electrical 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 document is not intended to be used as the basis of regulatory inspection or certification
assessment activities.
2 Normative references
None.
There are no normative references in this document.
NOTE Informative references including IEC and ISO standards are listed in the Bibliography starting on page 30.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 34.
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 equipment themselves.
[SOURCE: IEC 60601-1:2005, 3.3, modified – A note to entry has been added.]
3.2
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT between the
PATIENT connection and DIALYSER connection
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump
(typically negative), and post-pump pressure (typical positive), which is downstream of the blood pump.
[SOURCE: IEC 60601-2-16:20122018, 201.3.201, modified – Direction of pressure added.]
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 60601-2-16:20122018, 201.3.202, modified – The original note to entry has
been replaced.]
3.4
CENTRAL CONCENTRATE SYSTEM
system that prepares and/or stores concentrate at a central point for subsequent distribution
to its points of use
3.5
CENTRAL DIALYSIS FLUID DELIVERY SYSTEM
system that produces DIALYSIS FLUID from DIALYSIS WATER and concentrate or powder at a
central point and distributes the DIALYSIS FLUID from the central point to individual dialysis
consoles
3.6
DIALYSER
device containing a semi-permeable membrane that is used to perform HAEMODIALYSIS,
HAEMODIAFILTRATION or HAEMOFILTRATION
2018, 201.3.204]
[SOURCE: IEC 60601-2-16:2012
* 3.7
DIALYSIS FLUID
aqueous fluid containing electrolytes and usually buffer and glucose, which is intended to
exchange solutes with blood during HAEMODIALYSIS and HEMODIAFILTRATION
– 10 – IEC TR 62653:2020 RLV © IEC:2020
Note 1 to entry: The term “DIALYSIS FLUID” is used throughout this document to mean the fluid made from DIALYSIS
WATER and concentrates that is delivered to the DIALYSER by the DIALYSIS FLUID delivery system. Such phrases as
“dialysate” or “dialysis solution” or “dialysing fluid” may be are used in place of DIALYSIS FLUID in some countries;
however, that usage is discouraged to avoid confusion.
Note 2 to entry: ISO 23500-5 defines three levels of DIALYSIS FLUID: standard DIALYSIS FLUID, ultrapure DIALYSIS
FLUID, and online-prepared substitution fluid used for HAEMODIAFILTRATION.
Note 3 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 4 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 ISO 23500-1:2019, 3.15, modified – The terms "dialysate"
and "dialysis solution" were deleted.]
* 3.8
DIALYSIS MACHINE
HAEMODIALYSIS MACHINE
HAEMODIAFILTRATION MACHINE
HAEMOFILTRATION MACHINE
system or combination of units medical electrical equipment 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 A.6).
Note 2 to entry: The DIALYSIS MACHINE can be supplied with DIALYSIS FLUID from a CENTRAL DIALYSIS FLUID
DELIVERY SYSTEM and synonymously named individual dialysis console in this context (see A.7).
3.9
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 13959 ISO 23500-3 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
[SOURCE: ISO 13959:2009, 2.5 ISO 23500-1:2019, 3.17]
3.10
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.]
* 3.11
EXTRACORPOREAL CIRCUIT
blood lines, DIALYSER and any integral ACCESSORY thereof
[SOURCE: IEC 60601-2-16:20122018, 201.3.207, modified – Deletion of Note to entry.]
3.12
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 60601-2-16:20122018, 201.3.208]
3.13
HAEMODIALYSIS
HD
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 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. This process typically includes fluid removal by filtration. This process is usually also accompanied
by diffusion of substances from the DIALYSIS FLUID into the blood.
[SOURCE: IEC 60601-2-16:20122018, 201.3.209, modified – the original note to entry has
been replaced]
3.14
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
process whereby concentrations of water-soluble substances in a PATIENT'S blood and an
PATIENT are corrected by convective transport via ultrafiltration and partial
excess of fluid of a
replacement by a substitution fluid resulting in the required net fluid removal
[SOURCE: IEC 60601-2-16:20122018, 201.3.211, modified – an error has been corrected]
3.15
HAZARD
potential source of harm
[SOURCE: ISO 14971:2007, 2.3 2019, 3.4]
3.16
HAZARDOUS SITUATION
circumstance in which people, property, or the environment are exposed to one or more
HAZARD(S)
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.40]
3.17
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 equipment, 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
3.18
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 2019, 3.6, modified – Deletion of the Note.]
– 12 – IEC TR 62653:2020 RLV © IEC:2020
3.19
MAINTENANCE
combination of all technical and administrative means, including supervising ones, to keep or
restore a unit in working condition medical electrical equipment or a medical electrical system
in a normal working condition or restored to normal working condition
Note 1 to entry: Unit can be a device or a system.
[SOURCE: IEC 62353:20072014, 3.19, modified – a note to entry has been added 3.21]
3.20
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
Note 1 to entry: In the context of this document the term medical equipment is used as umbrella term for medical
electrical equipment and non-active medical devices.
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.55, modified – The original notes to entry have
been deleted.]
3.21
MODIFICATION
equipment or a medical
changing constructional or functional features of medical electrical
electrical system in a way not described in its instruction for use or other accompanying
documents (instructions for use)
[SOURCE: IEC 62353:20072014, 3.23 3.25, modified – A note to entry has been deleted and
a reference to instructions for use has been added.]
3.22
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.]
3.23
ORGANIZATION
application and MAINTENANCE
entity of the persons and/or institutions responsible for the use
of systems for extracorporeal renal replacement therapy
EXAMPLES Doctor's office Medical doctors, dialysis centers and dialysis clinics and their responsible parties.
3.24
PATIENT
living being (person or animal) undergoing a medical, surgical or dental procedure
Note 1 to entry: A PATIENT can be an OPERATOR.
Note 2 to entry: For the purpose of this document PATIENT is a human being
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.76, modified – Addition of a new Note 2 to
entry.]
3.25
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.
Dimensions in metres
PATIENT ENVIRONMENT
Figure 1 – Example
[SOURCE: IEC 60601-1:2005, 3.79, modified – Two notes to entry have been added,
including a figure illustrating the term.]
* 3.26
PATIENT LEAKAGE CURRENT
current coming from a medical electric device equipment and flowing through the PATIENT to
the ground
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.]
3.27
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
– 14 – IEC TR 62653:2020 RLV © IEC:2020
[SOURCE: IEC 60601-1:2005, 3.86, modified – Note deleted.]
3.28
PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDS which can arise HAZARDOUS SITUATIONS
[SOURCE: IEC 60601-2-16:20122018, 201.3.215]
3.29
REPAIR
means for reconstitution of a defined restoring to a safe, functional, normal condition
[SOURCE: IEC 62353:20072014, 3.35 3.39]
3.30
SERVICING
combination of all means for maintaining the medical electrical equipment or medical
electrical system within requirements of the MANUFACTURER
[SOURCE: IEC 62353:2014, 3.37 3.41]
3.31
SORBENT DIALYSIS SYSTEM
DIALYSIS FLUID is generated from potable water and spent DIALYSIS
method of dialysis where
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
* 3.32
TOUCH CURRENT
appropriate functioning, coming from the ENCLOSURE or parts
current not necessary for proper
thereof (except PATIENT connectors), which the OPERATOR or PATIENT may touch while using
the medical electrical 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)
3.33
TRANSMEMBRANE PRESSURE
TMP
fluid pressure difference exerted across the semi-permeable membrane of the DIALYSER
Note 1 to entry: Generally, the mean TMP is used. In practice, the displayed TRANSMEMBRANE PRESSURE is usually
estimated from the measured EXTRACORPOREAL CIRCUIT pressure minus the measured DIALYSIS FLUID pressure,
each obtained at a single point.
[SOURCE: IEC 60601-2-16:2018, 201.3.217]
3.34
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT between the
DIALYSER connection and PATIENT connection (typically positive)
[SOURCE: IEC 60601-2-16:20122018, 201.3.219, modified – Direction of pressure added]
4 Requirements Recommendations
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 the medical electrical equipment, medical
devices, ACCESSORIES 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 electrical
equipment, medical devices, but also in the procedures that should be followed in the event of
an INCIDENT arising from the use of the medical 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 medical electrical equipment, medical devices or systems 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
MANUFACTURERS, because these instructions are crucial to avoid remaining / residual risks
not technically mitigated by the medical equipment themselves.
b) The training should be based on the valid instructions for use and include any unit
protocols, actions or interventions needed in case of alarms, cautions, or medical
equipment failure. The instructions for use should be available at any time.
c) Only ORGANIZATIONS that have received training from the MANUFACTURERS of the medical
electrical equipment or system can develop a training program to train additional
personnel within that ORGANIZATION to operate the devices medical electrical equipment or
system.
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, modality prescription, effective administration of
medications, how to detect, report, and manage dialysis complications and procedures for
the detection, reporting and management of both medical and non-medical complications
arising from the treatment.
f) If MODIFICATIONS by the MANUFACTURER become are necessary, the MANUFACTURER decides
to what extent an additional training guided by the MANUFACTURER is necessary should
provide written documentation regarding the MODIFICATIONS undertaken. If necessary, the
MANUFACTURER should also provide appropriate additional training.
g) The completion of any training program should be documented by the ORGANIZATION.
h) The medical electrical equipment, medical devices or systems should be operated in
accordance 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 medical equipment or
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
– 16 – IEC TR 62653:2020 RLV © IEC:2020
appropriate rooms and drugs (e.g. pre-manufactured fluid bags) and medical devices
equipment should be used 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 BLOOD LEAKS and air in the
EXTRACORPOREAL CIRCUIT). Such PROTECTIVE SYSTEMS may be subject to damage and should,
appropriate functioning at regular intervals according to the
therefore, be checked for proper
MANUFACTURER’S instructions. Failure to complete the automated checks prior according to
commencement of the dialysis procedure the MANUFACTURER’S instructions places the PATIENT
at risk, and technical advice prior to the commencement of the treatment should be sought.
4.3.2 Infrastructure requirements recommendations
4.3.2.1 Technical requirements recommendations in rooms
Rooms, except rooms in the home healthcare environment, which are intended for
employment of HAEMODIALYSIS systems according to IEC 60601-1 are medically used rooms of
Group 1 as defined in IEC 60364-7-710.
The electric connection of a DIALYSIS MACHINE of class I should be established by a socket
outlet with tested grounding by protective earth and a plug which cannot be mistaken for other
socket outlets.
Possible examples are: socket outlets and plugs according to IEC 60309-2, colour code
identification of the power socket dedicated to the machine. Power cord and plugs should be
according to MANUFACTURER´s instructions.
Use of adaptors or extension cords, not approved by the MANUFACTURER of the medical
HAZARDS. Each
electrical equipment, with grounded machines could lead to electrical safety
The treatment location should be provided with an additional potential equalization connector
tested according to IEC 60364-7-710, (see 710.413.1.6, additional potential equalization, of
IEC 60364-7-710:2002). If central venous catheters with atrial location whose tip is in the right
atrium are used for the vascular access, special measures might be necessary for complying
with electrical safety requirements [13], [14], [15], [16]. The MANUFACTURER´S instructions
should be followed.
Possible examples are: socket outlets and plugs according to IEC 60309-2, colour code
identification of the power socket dedicated to the machine. Power cord and plugs should be
according to MANUFACTURER´s instructions.
If an emergency occurs during the dialysis treatment, it should be possible to alert the person
taking care of the PATIENTS and or emergency medical services.
DIALYSIS MACHINE from being contaminated with viruses, bacteria,
In order to prevent the
endotoxins and fungi by retroactive effect from the drain, the device medical electrical
equipment MANUFACTURER’S instructions in the instructions for use should be followed for
installation of the drain tube.
In addition, it is recommended that drains intended to discharge the spent DIALYSIS FLUID be
provided with a stench trap.
Handling of waste liquids to the drain should comply with the local regulations.
If conditions are unfavorable, e.g. in case of backflow, the DIALYSIS MACHINE might become
contaminated. To prevent this, the minimum distance of the drain opening from the level of
the sewage water should not be less than 2 cm or according to the MANUFACTURER’S
specification or according to local regulations.
—————————
Numbers in square brackets refer to the Bibliography.
4.3.2.2 Water treatment and distribution
ISO 23500-2 should be taken as reference.
4.3.2.3 Concentrate supply
ISO 23500-4 should be taken as reference.
4.3.2.4 Responsibilities for on-site preparation of fluids
ISO 23500-1 should be taken as reference.
4.3.2.5 Infection control
Each ORGANIZATION should have in place an infection control plan policy for the protection of
PATIENTS and personnel against infections [1], [2]. This policy should be dated, with its review
date clearly indicated.
The infection control plan policy should include specifications of how to manage both sterile
supplies and aseptic handling techniques.
The infection control policy should include specifications for prevention and control of blood
PATIENTS and staff. If treatment is performed away from the normal
borne virus infection in
treatment location (hospital/home) the measures needed to protect PATIENTS, support workers,
and others from the risk of blood-borne virus infections should be outlined.
Correct handling techniques typically include:
• hand hygiene,
• use of gloves and other protective equipment,
• use of face masks,
• technique for preparation of supplies to be used during the treatment,
• use of materials within use-by dates,
• technique for access preparation and access care,
• technique for blood and fluid connections,
• waste disposal,
• used disinfection methods.
In addition, the infection control plan policy should describes the management of cleaning and
disinfecting equipment and environmental services according to MANUFACTURER's instructions
and country specific regulations.
When the fluid pathways of DIALYSIS MACHINES are disinfected, the MANUFACTURER’s
instructions should be followed.
The infection control plan policy should include the disinfectant to be used for surface
disinfections, the required concentration and the minimum exposure time required by the
disinfecting agent in terms of bactericidal efficacy and inactivation of bloodborne viruses such
as HBV, HCV and HIV. Since surface disinfectants may damage the materials of the device,
MANUFACTURER’S recommendations should be taken into account.
If the infection status of PATIENTS is unknown with regard to blood-borne virus infections, the
appropriate measures should be taken to exclude any contamination of other PATIENTS.
Special measures are required for PATIENTS with virus infection transferred by blood according
to country regulations [2], [3], [4].
– 18 – IEC TR 62653:2020 RLV © IEC:2020
Measures for the return of DIALYSIS MACHINES used on PATIENTS with blood-borne virus
infections to a non-infectious area are, for example, described in “Guideline for Applied
Hygiene in Dialysis Units” – In German” [1] or local Infection Control Policies.
4.3.2.6 Other prerequisites
The equipment combinations covered by the INTENDED USE of the system are defined by the
MANUFACTURERS in their instructions for use and are applicable.
To assure compatibility of medical equipment and ACCESSORIES comprising the system, the
INTENDED USES and compatibilities of the medical equipment found in the instructions for use
should be taken into account.
4.3.2.7 Home HAEMODIALYSIS requirements recommendations
If the HAEMODIALYSIS equipment DIALYSIS MACHINE and associated water treatment equipment
are used in the PATIENT’S home, the requirements specified by the MANUFACTURER should be
followed. To comply with local requirements, it may additionally be necessary for the
installation to be examined by an approved expert to ensure that the quality of the alterations
meets the requirements specified by the MANUFACTURER of the DIALYSIS MACHINE and by the
MANUFACTURER of the water treatment and/or DIALYSIS FLUID preparation equipment.
It is recommended that home HAEMODIALYSIS PATIENTS have a communication device
equipment to permit contact with the supervising ORGANIZATION in the event of a medical
emergency and a backup communication device equipment in case of malfunction of the first
communication device equipment.
It is recommended that the room used for HAEMODIALYSIS contains emergency lighting
equipment such a flashlight or torch to provide illumination in the event of a power failure.
The PATIENT or carer should also be appropriately tra
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