ISO/FDIS 8637-2

ISO/TC 150/SC 2
Secretariat: ANSI
Date: 2026-06-26xx
Extracorporeal systems for blood purification —
Part 2:
Extracorporeal blood and fluid circuits for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 2: Circuits sanguins extracorporels et liquidiens pour les hémodialyseurs, les hémodiafiltres, les
hémofiltres et les hémoconcentrateurs
FDIS stage
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ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 7
4.1 General . 7
4.2 Biological safety and haemocompatibility . 7
4.3 Sterility . 7
4.4 Non-pyrogenicity . 7
4.5 Mechanical characteristics . 7
4.6 Functional characteristics . 12
4.7 Expiry date . 14
5 Test methods . 14
5.1 General . 14
5.2 Biological safety and haemocompatibility . 15
5.3 Sterility . 15
5.4 Non-pyrogenicity . 15
5.5 Mechanical characteristics . 16
5.6 Functional characteristics . 24
5.7 Expiry date . 25
6 Labelling . 25
6.1 Labelling on the device . 25
6.2 Labelling on unit protective packaging . 25
6.3 Labelling on the outer shipping container . 26
6.4 Information to be given in the accompanying documentation . 27
7 Packaging . 28
Annex A (informative) Rationale for the introduction of changes in mechanical characteristics
(structural integrity) . 29
Bibliography . 30

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 8637-2:2024), which has been technically
revised.
The main changes are:
— — introduction of a link to ISO 14971for 14971 for risk management procedures ;
— — addition of new terms to the definitions ( recommended pressure and foreseeable misuse);
— — detailing of the requirements for transducer protectors resistance;
— — detailing of the procedures for expiration date ;
— — revision of the testing procedure for access port leakage;
— — introduction of an Annex AAnnex A to explain the changes and to describe the further development of
the standard in the context of regulatory requirements.
A list of all the parts in the ISO 8637 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
This document is concerned with the extracorporeal blood and fluid circuits manufactured for single use and
intended for use in conjunction with haemodialysers, haemodiafilters, haemofilters and heamodialysis
equipment. The requirements specified in this document for the extracorporeal blood and fluid circuits will
help to ensure safety and satisfactory function.
There is no intention to specify, or to set limits on, the performance characteristics of the extracorporeal blood
and fluid circuits manufactured for single, nor to specify the materials acceptable for use. Such restrictions are
unnecessary for the qualified user and would limit the alternatives available when selecting the extracorporeal
blood and fluid circuits manufactured for single use for a specific application.
All materials used in the manufacture of the extracorporeal blood and fluid circuits meet the necessary
mechanical strength requirements as well as those relating to biocompatibility thrombogenicity and
pyrogenicity after sterilization and have been appropriately tested. The methods used and the test results are
available on request.
To minimize the risk of accidental disconnection, the leakage of blood, and the ingress of air during use, the
design and the dimensions of the connectors intended for connecting the extracorporeal blood and fluid
circuits to devices, specified in ISO 8637-1 (haemodialysers, haemodiafilters or haemofilters) have been
selected to ensure compatibility. Connectors with either fixed or loose locking shells are allowed.
This document reflects the consensus of physicians, manufacturers and other interested parties for
extracorporeal blood and fluid circuits approved for clinical use.
v
Extracorporeal systems for blood purification —

Part 2:
Extracorporeal blood and fluid circuits for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators
1 Scope
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories
used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies
such as, but not limited to, haemodialysis, haemodiafiltration and haemofiltration.
This document does not apply to:
— — haemodialysers, haemodiafilters or haemofilters;,
— — plasmafilters;,
— — haemoperfusion devices;, and
— — vascular access devices.
NOTE 1 Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are addressed in ISO 8637-1.
NOTE 2 Plasmafilters are specified in ISO 8637-3.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 7864, Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993--1, Biological evaluation of medical devices — Part 1: Requirements and general principles for the
evaluation of biological safety within a risk management process
ISO 10993--4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993--11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11607--1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607--2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming,
sealing and assembly processes
ISO 11737--2, Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 23500-3, Preparation and quality management of fluids for haemodialysis and related therapies — Part 3:
Water for haemodialysis and related therapies
ISO 80369--7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
ISO 80369--20:2024, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common
test methods
IEC 60601--2-16:2025, Medical electrical equipment –— Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/
3.1 3.1
active medical device
medical device that relies on a source of energy other than that generated by the human body for that purpose,
or by gravity, and which acts by changing the density of that energy or converting that energy
Note 1 to entry: Devices intended to transmit energy, substances or other elements between an active device and the
patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an
active device.
3.2 3.2
air capture chamber
drip chamber
bubble trap
venous and arterial blood chamber
component intended to capture air, and which can also provide volume expandability to the blood circuit or
allow pressure to be monitored
Note 1 to entry: Air capture chambers can be equipped with a filter that captures blood thrombi.
3.3 3.3
arterial pressure
pressure measured in the blood withdrawal segment or line of the extracorporeal blood circuit between the
patient connection and dialyzer connection
Note 1 to entry: The withdrawal segment of the extracorporeal circuit can be referred to as the arterial or blood access
side.
Note 2 to entry: Pressure in the segment of the extracorporeal circuit taking the blood from the patient can be further
differentiated as the pre-pump pressure, which relates to the extracorporeal circuit before the blood pump, and post-
pump pressure, which relates to the segment of the extracorporeal blood circuit between the blood pump and the inlet
to the dialyser.
3.4 3.4
basic safety
freedom from unacceptable risk caused directly by physical hazards when haemodialysis system (3.16(3.16))
is used under normal condition and single fault condition
[8]
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020 ]
[10]
, 3.10 5]
3.5
blood leak
movement of blood from the blood compartment to the dialysis fluid (3.7(3.7)) compartment of the dialyzer
or movement from the blood compartment to the environment
[SOURCE: IEC 60601-2-16:2025,], 201.3.202]
3.53.6 3.6
blood pathway
internal surfaces of the blood circuit
3.63.7 3.7
dialysis fluid
dialysing fluid
DEPRECATED: dialysate
DEPRECATED: dialysis solution
aqueous fluid made from dialysis water (3.9(3.9)) containing electrolytes and, usually, buffer and glucose,
which is intended to exchange solutes with blood during haemodialysis (3.14(3.14)) or haemodiafiltration
(3.17(3.17))
Note 1 to entry: The term “dialysis fluid” is used throughout this document to mean the fluid [made from dialysis water
(3.9(3.9)) and concentrates] which is delivered to the haemodialyser or haemodiafilter by a dialysis fluid delivery system.
Note 2 to entry: The dialysis fluid entering the haemodialyser or haemodiafilter is referred to as “fresh dialysis fluid”,
while the fluid leaving the haemodialyser or haemodiafilter is referred to as “spent dialysis fluid”.
Note 3 to entry: Dialysis fluid does not include pre-packaged parenteral fluids used in some renal replacement therapies,
such as haemodiafiltration (3.17(3.17)) and haemofiltration (3.18(3.18).).
[7]
[SOURCE: ISO 23500-1:2024 ]
, 3.815]
3.73.8
dialysis fluid concentrate
mixture of chemicals and water or chemicals in a highly concentrated media which are mixed with dialysis
water (3.9(3.9)) to produce dialysis fluid (3.7(3.7))
Note 1 to entry: Chemicals can also be in the form of a dry powder.
3.83.9 3.9
dialysis water
water that has been treated and which is suitable for use in haemodialysis (3.14(3.14)) applications, including
the preparation of dialysis fluid (3.7(3.7),), reprocessing of dialyzers, preparation of concentrates and
preparation of substitution fluid (3.29(3.29)) for online convective therapies
3.93.10 3.10
essential performance
performance of a clinical function, other than that related to basic safety (3.4(3.4),), where loss or degradation
beyond the limits specified by the manufacturer (3.20(3.20)) results in an unacceptable risk
Note 1 to entry: Essential performance is most easily understood by considering whether its absence or degradation
would result in an unacceptable risk.
[10] [8]
[SOURCE: IEC 60601-1:2005+A1:2012+A2:2020, 3.27 , ]]
3.103.11 3.11
extracorporeal blood circuit
blood circuit
disposable circuit with direct contact to blood or blood components, used to perform either haemodialysis
(3.14(3.14),), haemodiafiltration (3.17(3.17)) or haemofiltration (3.18(3.18))
Note 1 to entry: The extracorporeal blood circuit can also contain accessory tubing for attaching the extracorporeal blood
circuit to monitors forming part of the haemodialysis system (3.16(3.16))
Note 2 to entry: Extracorporeal blood circuits can also be used for other extracorporeal therapies such as
plasmafiltrationplasma filtration and plasma adsorption.
3.113.12 3.12
fluid circuit
disposable circuit with indirect or no contact with blood or blood components, used to perform either
haemodialysis (3.14(3.14),), haemodiafiltration (3.17(3.17)) or haemofiltration (3.18(3.18))
Note 1 to entry: to entry Fluid circuit can include circuits for dialysis fluid (3.7(3.7) )dialysis water (3.9(3.9)) and
concentrates as well as for infusion or monitoring
Note 2 to entry: Fluid circuits can also be used for other extracorporeal therapies such as plasmafiltrationplasma
filtration and plasma adsorption.
3.123.13 3.13
fluid pathway
internal surfaces of the fluid circuit (3.12(3.12))
3.133.14 3.14
haemodialysis
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 (3.7(3.7))
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.
3.143.15 3.15
haemodialysis equipment
active medical device (3.1(3.1)) used to perform either haemodialysis (3.14(3.14),), haemodiafiltration
(3.17(3.17)) or haemofiltration (3.18(3.18))
[SOURCE: IEC 60601-2-16:2025]
3.153.16 3.16
haemodialysis system
extracorporeal blood and fluid circuits (3.12(3.12),), in combination with haemodialysis equipment
(3.15(3.15),), haemodialysers, haemodiafilters or haemofilters,
Note 1 to entry: Haemodialysers, haemodiafilters or haemofilters are covered in ISO 8637-1.
3.163.17 3.17
haemodiafiltration
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 haemodialysis and haemofiltration
Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid (3.7(3.7)) stream as in haemodialysis
(3.14(3.14).). Enhanced convective solute removal is achieved by adding ultrafiltration in excess of that needed to achieve
the desired weight loss; fluid balance is maintained by the infusion of a replacement solution into the blood circuit either
before (pre-dilution haemodiafiltration) or after (post-dilution haemodiafiltration) or a combination of the two (mixed
dilution haemodiafiltration).
[SOURCE: IEC 60601-2-16:2025, 201.3.209, modified — Note 1 to entry has been added.]
3.173.18 3.18
haemofiltration
process whereby concentrations of water-soluble substances in a patient’s blood and an excess of fluid of a
patient are corrected by convective transport via ultrafiltration and partial replacement by a substitution fluid
(3.29(3.29)) resulting in the required net fluid removal (3.22(3.22))
Note 1 to entry: Convective transport is achieved by ultrafiltration across a high flux membrane. Fluid balance is
maintained by the infusion of a replacement solution into the blood either before the haemofilter (pre-dilution
haemofiltration) or after the haemofilter (post-dilution haemofiltration) or a combination of the two (mixed dilution
haemofiltration).
Note 2 to entry: In haemofiltration, there is no dialysis fluid stream.
[SOURCE: IEC 60601-2-16:2025, 201.3.211, modified — Notes 1 and 2 to entry have been added.]
3.183.19 3.19
labelling
written, printed, graphic or electronic matter that is affixed to the extracorporeal blood or fluid circuit
(3.12(3.12)) packaging and container which is related to identification, technical description and use of the
circuit but excluding shipping documentation
3.193.20 3.20
manufacturer
natural or legal person responsible for the design, manufacture, packaging or labelling (3.19(3.19)) of the
extracorporeal circuit or the fluid circuit (3.12(3.12),), assembling an extracorporeal circuit or a fluid circuit,
or adapting an extracorporeal circuit or a fluid circuit, 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 some jurisdictions, the responsible organization can be considered as a manufacturer when involved
in the activities described.
3.203.21 3.21
maximum recommended pressure
pressure that the disposable can withstand without damage or functional impairment
3.213.22 3.22
net fluid removal
DEPRECATED: weight loss
fluid loss from the patient
[SOURCE: IEC 60601-2-16:2025,]
, 201.3.23212]
3.223.23
non-active medical device
medical device without an integral power source
EXAMPLE A non-active medical device can be a disposable extracorporeal bloodcircuit (3.11blood circuit (3.11)) or
fluid circuit (3.12(3.12).).
3.233.24 3.24
protective measure
constructional feature, specifically designed to protect the patient or user against hazardous situations
3.243.25 3.25
pump system
portion of either the extracorporeal blood circuit (3.11(3.11)) or the fluid circuit (3.12(3.12)) that is acted upon
by the pumping mechanism forming part of the haemodialysisequipment (3.15haemodialysis equipment (3.15))
3.253.26 3.26
reasonably foreseeable misuse
use of a product or system in a way not intended by the manufacturer (3.20(3.20),), but which can result from
readily predictable human behaviour
Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and
professional users.
Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional.
[SOURCE: ISO 14971;/IEC Guide 63:2019]
, 3.278]
3.263.27
rigid material
material with a modulus of elasticity either in flexure or in tension greater than 3 433 MPa
EXAMPLE Metal, glass, some fibre-reinforced polymers and high-performance polymers.
3.273.28 3.28
semi-rigid material
material with a modulus of elasticity either in flexure or in tension between 700 and 3 433 MPa
EXAMPLE Thermoplastics.
3.283.29 3.29
substitution fluid
fluid used in haemofiltration (3.18(3.18)) and haemodiafiltration (3.17(3.17)) treatments which is infused
directly infused into the patients’ blood as a replacement for the fluid that is removed from the blood by
ultrafiltration
Note 1 to entry: Substitution fluid can also be used for administering a bolus, priming an extracorporeal blood circuit
and returning blood to the patient at the end of a treatment.
[7]
[SOURCE: ISO 23500-1:2024 ]
, 3.3040]
3.293.30
transducer protector
pressure-transmitting sterile barrier
component of either the extracorporeal blood circuit (3.11(3.11)) or the fluid circuit (3.12(3.12)) that provides
a sterile interconnection between the extracorporeal circuits and haemodialysis equipment (3.15(3.15)) while
allowing the pressure within the extracorporeal circuits to be measured by the haemodialysis equipment
3.303.31 3.31
venous pressure
pressure measured in the blood return segment or line of the extracorporeal blood circuit between the
dialyzer connection and patient connection
Note 1 to entry: The return segment of the extracorporeal blood circuit between the dialyser connection and the patient
connection can be referred to as the venous or blood return side.
4 Requirements
4.1 General
This clause gives the requirements for an extracorporeal blood and fluid circuit.
The evaluation of requirements of this conform shall form part of a structured evaluation plan within a risk
management process in accordance with ISO 14971.
4.2 Biological safety and haemocompatibility
Parts of the disposable circuit intended to come into direct or indirect contact with blood shall be evaluated
within a documented biological and haemocompatibility plan in accordance with ISO 10993-1 and ISO 10993-
4. The plan shall identify the contact type and duration and select appropriate blood interaction endpoints
proportionate to clinical risk. The key endpoints for blood-material interactions include thrombosis,
coagulation, platelets, hematology (including hemolysis), and complement activation. . Haemocompatibility
shall be verified as specified in 5.25.2.
4.3 Sterility
The blood and fluid pathways of the circuit and the internal mating surfaces of all connectors in contact
(directly or indirectly) with blood during use shall be sterile. Conformity shall be verified in accordance with
5.35.3.
4.4 Non-pyrogenicity
The blood and fluid pathways of the circuit and the internal mating surfaces of all connectors in contact with
blood during use shall be non-pyrogenic. Conformity shall be verified in accordance with 5.45.4.
NOTE 1 Pyrogenicity in this context refers to endotoxin mediated pyrogenicity. Material mediated pyrogenicity is
addressed under 4.24.2.
NOTE 2 Elements of the blood and fluid circuits can have sections that are never in direct or indirect contact to the
blood. Such elements do not require to be non-pyrogenic.
4.5 Mechanical characteristics
4.5.1 Structural integrity
The device shall be capable of withstanding the maximum positive pressure above atmospheric pressure and
the maximum negative sub-atmospheric pressure that can occur in the haemodialysis system in accordance
with the outputs of the manufacturer’s risk management process. Considerations include, but are not limited
to, the type of application, duration of treatment, pressures and temperatures encountered, and reasonably
foreseeable misuse. For basic safety, single fault condition shall also be considered in the assessment. (See also
Annex AAnnex A for further guidance). Alternatively, use the maximum recommended pressure from the
manufacturer to verify structural integrity.
Conformity shall be verified in accordance with 5.5.15.5.1.
4.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
4.5.2.1 General
All connectors that connect haemodialysers, haemodiafilters haemofilters or haemoconcentrators to the
extracorporeal blood circuit shall provide a safe connection. To ensure a safe connection, leakage of air from
the outside or loss of blood to the environment shall be avoided. The degree of acceptable leakage rate,
minimum separation force, minimum separation torque and maximum connection torque at this position in
the haemodialysis system shall be defined in accordance with the outputs of the manufacturer’s risk
management process. Boundary parameters used in tests, such as torques, connection forces and
disconnection forces, holding times, and ambient temperatures, shall be considered and defined as part of the
manufacturer's assessment on the use of the product. The selected forces and torques used in tests shall be
representative of the typical physical conditions of users. If necessary, occupational health and safety
guidelines for maximum permissible torques and forces should be taken into account.
4.5.2.2 Dimensional requirements
Except where the haemodialysers, haemodiafilters haemofilters or haemoconcentrators and the
extracorporeal blood circuit are designed as an integral system, the dimensions, and tolerances of the
connectors to the haemodialysers, haemodiafilters or haemofilter shall conform to the dimensions and
tolerances given in Figure 1Figure 1 and Table 1Table 1. Conformity shall be verified in accordance with
5.5.2.25.5.2.2.
8637-2_ed3fig1.EPS
Key
X thread length
Y thread width
α angle of thread
β angle of thread
γ dimension taper rate
δ thread
E length of tapered region
S cone diameter for socket
V core diameter
W root diameter
Figure 1 — Main fitting dimensions of blood circuit connector to the blood compartment connector
of haemodialysers, haemodiafilters haemofilters or haemoconcentrators
Table 1 — Blood circuit connector dimensions
a b b
δ S V
α β γ E W X Y
a b b
δ S V
° ° mm mm mm mm
mm mm mm
Minimum — — — 6,33 — 12,60 — 1,90
10 or 10,55 or 4,00 or
Nominal 15 15 6:100 8,0 6,33 12,80 2,0
more less more
Maximum — — — 6,405 — 12,80 — 2,10
a b b
δ S V
α β γ E W X Y
a b b
δ S V
° ° mm mm mm mm
mm mm mm
Key
α angle of thread
β angle of thread
γ dimension taper rate
δ thread
E length of tapered region
S cone diameter for socket
V core diameter
W root diameter
X thread length
Y thread width
a  Double thread pitch.
b  Socket connectors manufactured from soft or semi-rigid materials are not required to fulfil dimensional requirements but are
required to verify conformity with functional requirements.
4.5.2.3 Leakage by pressure decay
Connectors to the haemodialysers, haemodiafilters, haemofilters or haemoconcentrators made of soft or semi-
rigid material, shall not exceed a defined leakage rate while being subjected to a defined pressure over a
defined holding period using air as the medium. Conformity shall be verified in accordance with 5.5.2.35.5.2.3.
4.5.2.4 Sub-atmospheric pressure air leakage
Connectors to the haemodialysers, haemodiafilters, haemofilters or haemoconcentrators made of soft or semi-
rigid material, shall be evaluated for sub-atmospheric pressure air leakage. Connectors to the haemodialysers,
haemodiafilters, haemofilters or haemoconcentrators shall not leak by more than defined while being
subjected to a defined sub-atmospheric pressure over a defied holding period. Conformity shall be verified in
accordance with 5.5.2.45.5.2.4.
4.5.2.5 Stress cracking
Connectors to the haemodialysers, haemodiafilters haemofilters or haemoconcentrators made of soft or semi-
rigid material, shall be evaluated for stress cracking. Conformity shall be verified in accordance with
5.5.2.55.5.2.5.
4.5.2.6 Resistance to separation from axial load
Connectors to the haemodialysers, haemodiafilters haemofilters or haemoconcentrators made of soft or semi-
rigid material, shall be evaluated for separation from axial load. Connectors to the haemodialysers,
haemodiafilters haemofilters or haemoconcentrators shall not separate from the reference connector over a
defined holding period while being subjected to a defined axial disconnection force. Conformity shall be
verified in accordance with 5.5.2.65.5.2.6.
4.5.2.7 Resistance to separation from unscrewing
Connectors to the haemodialysers, haemodiafilters haemofilters or haemoconcentrators made of soft or semi-
rigid material, shall be evaluated for separation from unscrewing. Connectors to the haemodialysers,
haemodiafilters or haemofilter shall not separate from the reference connector for a defined holding period
while being subjected to a defined unscrewing torque. Conformity shall be verified in accordance with
5.5.2.75.5.2.7.
4.5.2.8 Resistance to overriding
Connectors to the haemodialysers, haemodiafilters haemofilters or haemoconcentrators made of soft or semi-
rigid material, connectors shall be evaluated for resistance to overriding. Connectors to the haemodialysers,
haemodiafilters or haemofilter shall not override the threads or lugs of the reference connector while being
subjected to a defined torque over a defined holding period. Conformity shall be verified in accordance with
5.5.2.85.5.2.8.
4.5.3 Connectors to vascular access device
Except where the extracorporeal blood circuit and the vascular access device are an integral system, the
dimensions of the connectors intended for connection to vascular access devices shall be a conical type 6 %
(Luer) taper lock fitting and meet the performance requirements of ISO 80369-7. Connectors made of semi-
rigid materials shall similarly meet the performance requirements of ISO 80369-7. Conformity shall be
verified in accordance with 5.5.35.5.3.
4.5.4 Connectors to ancillary components
All parts of the extracorporeal blood circuit and fluid circuits intended for use with non-integral ancillary
components, such as heparin lines, pressure-transducer lines, medication-administration lines and level-
adjustment lines, shall terminate in fittings that meet the performance requirements of ISO 80369-7.
Conformity shall be verified in accordance with 5.5.45.5.4.
4.5.5 Colour coding
The patient-connection end and connectors to haemodialysers, haemodiafilters haemofilters or
haemoconcentrators of the arterial side shall be colour-coded red, those for the venous side shall be colour-
coded blue. The colour coding shall be prominently displayed within 100 mm of the end of the tubing.
Conformity with this requirement shall be verified in accordance with 5.5.55.5.5.
NOTE The arterial side is defined as the segment of the extracorporeal circuit taking the blood from the patient to
the haemodialyser. The venous side is defined as the section of the haemodialysis circuit returning the blood to the
patient.
Different colours shall be used to identify other parts of the system in accordance with to the outputs of the
manufacturer’s risk management process.
4.5.6 Access ports
4.5.6.1 Needle access ports
The access ports shall be designed so as to minimize the risk of the needle piercing the tube completely and
causing injury to the user.
Needle access ports shall not leak when tested in accordance with 5.5.6.15.5.6.1.
4.5.6.2 Needleless access ports
Needleless access ports shall not leak when tested in accordance with 5.5.6.25.5.6.2.
4.5.7 Blood pathway volume
The range of the volume contained within the blood pathway volume of the extracorporeal blood circuits shall
be specified by the manufacturer.
Conformity with this requirement shall be verified in accordance with 5.5.75.5.7.
NOTE The blood pathway volume together with the volume contained within the blood pathway of the device to
which it is connected to is generally referred to as the circuit priming volume.
4.5.8 Air capture chamber fill level
The recommended fill level of the air capture chamber should be marked on the air capture chamber if that
level is required for proper operation of the monitoring system.
Conformity with this requirement shall be verified in accordance with 5.5.85.5.8.
4.5.9 Transducer protectors
Extracorporeal blood and fluid circuits shall be supplied with integral or non-integral transducer protectors
capable of preventing cross-contamination and enabling pressure monitoring, usually the arterial pressure
and venous pressure. The transducer protector shall be capable of maintaining a secure and leak-free
connection to the haemodialysis equipment via fittings that meet the performance requirements given in
ISO 80369-7 when subjected to the operating pressure range as defined in 4.5.14.5.1. The haemodialysis
equipment side of the transducer protector shall be transparent (clear) to allow for visual inspection of blood
contamination during use. Conformity with this requirement shall be in accordance with 5.5.95.5.9.
4.6 Functional characteristics
4.6.1 General
Functional characteristics are haemodialysis system related properties that are typically a result of the
combination of the non-active medical device referred to as the device and the active medical device, referred
to as the haemodialysis equipment. Therefore, the conformity with the requirements is affected by the system
behaviour and can only be determined in the combination of disposable and haemodialysis equipment. As a
minimum requirement, all applicable basic safety and essential performance characteristic of the
haemodialysis system shall be assessed.
There are two options to state conformity of functional characteristics, either may be used.:
— — Conformityconformity of the disposable equipment with functional characteristics shall be stated in
the accompanying documentation.;
— — Conformityconformity with essential performance data that deviates from the haemodialysis
equipment specification shall be stated in the accompanying documentation.
4.6.2 Blood pump system performance
The pump system intended to generate blood flow through the extracorporeal blood circuit shall be specified
by the manufacturer.
The specification shall include the pump segment fatigue for the maximum specified usage life of the
extracorporeal blood circuit.
Conformity with this requirement shall be verified in accordance with 5.6.25.6.2.
NOTE 1 A blood flow rate lower than the set value is considered detrimental for a typical treatment. Therefore, the
goal of testing is to find the highest negative blood flow rate error.
NOTE 2 Due to the pump segment fatigue, it can be reasonable to specify a delivered blood volume (blood flow rate
integrated over the treatment time) instead of a blood flow rate.
4.6.3 Dialysis fluid pump performance
If the non -active device contains a fluid circuit that is part of the dialysis fluid delivery, the dialysis fluid flow
rate of the fluid circuit in combination with a specified haemodialysis equipment shall be delivered as specified
by the manufacturer.
Conformity with this requirement shall be verified in accordance with 5.6.35.6.3.
NOTE A dialysis fluid flow rate lower than the set value is considered detrimental for a typical treatment.
4.6.4 Net fluid removal
If the non -active medical device contains a fluid circuit that is used in the net fluid removal function of the
haemodialysis equipment, the net fluid removal of the fluid circuit in combination with a specified
haemodialysis equipment shall be achieved as specified by the manufacturer.
Conformity with this requirement shall be verified in accordance with 5.6.45.6.4.
4.6.5 Substitution fluid flow rate
If the non -active medical device contains a fluid circuit that is used in the substitution fluid delivery, e.g. when
performing haemofiltration or haemodiafiltration, the substitution fluid flow rate of the fluid circuit in
combination with a specified haemodialysis equipment shall be specified by the manufacturer. Conformity
with this requirement shall be verified in accordance with 5.6.55.6.5.
NOTE The essential performance requirements for substitution fluid rate are defined in IEC 60601-2-
16:2025, 201.4.3.105.
4.6.6 Dialysis fluid composition
If the non -active medical device contains a fluid circuit that is used in the preparation of dialysis fluid from
dialysis water and dialysis fluid concentrate, the accuracy of the composition of the dialysis fluid shall be
specified by the manufacturer and conformity checked accordingly.
Conformity with this requirement shall be verified in accordance with 5.6.65.6.6.
4.6.7 Dialysis fluid temperature
If the non -active medical device contains a fluid circuit that is used in dialysis fluid temperature control
(essential performance) or temperature monitoring (basic safety), the temperature of the dialysis fluid shall
be achieved and monitored as specified by the manufacturer.
Conformity with this requirement shall be verified in accordance with 5.6.75.6.7.
4.6.8 Substitution fluid temperature
If the non -active medical device contains a fluid circuit that is used in substitution fluid temperature control
(essential performance) or temperature monitoring (basic safety), the substitution fluid temperature shall be
achieved and monitored as specified by the manufacturer.
Conformity with this requirement shall be verified in accordance with 5.6.85.6.8.
4.6.9 Fluid path occlusion
The extracorporeal blood circuit and fluid circuit shall be capable of being occlusively clamped by the control
and safety line clamps of the haemodialysis equipment with which the extracorporeal and fluid circuits are
intended to be used, as indicated in the labelling for the items.
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