ISO/FDIS 8637-1

• Abstract:

  This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: — extracorporeal blood circuits; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; — reprocessing procedures and equipment. NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

• Status: Not Published
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
• Drafting Committee: ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis
• Current Stage: 5000 - FDIS registered for formal approval
• Start Date: 18-Jun-2026
• Completion Date: 15-May-2026

• Revises: ISO 8637-1:2024 - Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
• Effective Date: 21-Sep-2024

Overview

ISO/FDIS 8637-1: Extracorporeal Systems for Blood Purification - Part 1 is an international standard developed by ISO. It specifies the requirements and test methods for haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators intended for use in humans. Collectively referred to as “the device”, this standard sets foundational criteria for the safety, efficacy, and performance of blood purification devices used in various renal replacement therapies, including haemodialysis, haemodiafiltration, haemofiltration, and haemoconcentration.

This document forms part of the ISO 8637 series, supporting medical device manufacturers, healthcare providers, and regulators to ensure consistent quality and safe use of critical extracorporeal blood purification devices.

Key Topics

• Device Scope: Focuses on haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators for human use. It does not cover extracorporeal blood circuits, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, reprocessing procedures, or systems for preparation or monitoring of dialysis fluid.
• Safety and Performance Requirements:
  • Biological Safety and Haemocompatibility: Assessment of materials in contact with blood to ensure absence of biological hazards and hemocompatibility.
  • Sterility and Non-pyrogenicity: Devices must be sterile and free of pyrogens in the blood pathway.
  • Mechanical and Structural Integrity: Devices must withstand treatment pressures and prevent leaks or breakage under normal and foreseeable misuse.
  • Connector Standards: Specifications for blood, dialysis fluid, and filtrate connectors to ensure safe and reliable connections and reduce the risk of disconnection or leakage.
• Performance Characteristics:
  • Assessment includes solute clearance, sieving coefficients, ultrafiltration rate and coefficient, blood compartment volume, pressure drops, and patient safety regarding endotoxin transfer.
• Labelling and Packaging: Requirements for product identification, instructions for use, labelling on unit/outer containers, and expiry date validation.
• Test Methods: Standardized risk-based testing for conformity prior to market introduction, after design changes, or in cases of multiple-use devices.

Applications

ISO/FDIS 8637-1 is vital for stakeholders in the medical device industry and healthcare settings, providing:

• Manufacturers with clear protocols for product design, testing, validation, and labelling, supporting compliance with international regulations and market entry requirements.
• Healthcare Providers with confidence that devices used for blood purification procedures-such as haemodialysis, haemodiafiltration, and haemofiltration-meet strict safety, performance, and biocompatibility requirements.
• Regulatory Bodies with harmonized criteria to evaluate device conformity, facilitating consistent enforcement and patient safety.
• Procurement and Quality Assurance Teams in hospitals or dialysis centres, by ensuring the products selected are standardized, compatible, and reliable for clinical practice.

By following this standard, organizations can reduce risks to patients, support clinical outcomes, and streamline the global supply of safe and effective blood purification devices.

Related Standards

• ISO 8637-2: Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters, and haemofilters.
• ISO 8637-3: Requirements for plasmafilters.
• ISO 10993 Series: Biological evaluation of medical devices including biocompatibility testing.
• ISO 11607 Series: Packaging for terminally sterilized medical devices.
• ISO 14971: Application of risk management to medical devices.
• ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications.

Conclusion

ISO/FDIS 8637-1:2026 is an essential standard for the development, testing, and use of extracorporeal systems for blood purification in clinical practice. Adherence to this standard ensures devices are safe, high-quality, and fit for purpose, supporting better outcomes for patients undergoing renal replacement therapies worldwide. For detailed information and specific compliance requirements, users are encouraged to refer to the full standard and consult relevant parts of the ISO 8637 series.

FINAL DRAFT
International
Standard
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
2026-09-21
Part 1:
Haemodialysers, haemodiafilters,
Voting terminates on:
2026-11-16
haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 150/SC 2
Extracorporeal systems for blood
Secretariat: ANSI
purification —
Voting begins on:
Part 1:
Haemodialysers, haemodiafilters,
Voting terminates on:
haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et
hémoconcentrateurs
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
ISO/FDIS 8637-1:2026(en)
Contents  Page
Foreword .v
Introduction .vi
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  Requirements . 5
4.1 General .5
4.2 Biological safety and haemocompatibility .5
4.3 Sterility .5
4.4 Non-pyrogenicity .6
4.5 Mechanical characteristics .6
4.5.1 Structural integrity.6
4.5.2 Blood compartment integrity .6
4.5.3 Haemodialysers, haemodiafilters and haemofilters blood compartment
connectors .6
4.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment connectors.8
4.5.5 Filtrate connectors of haemofilters .10
4.5.6 Blood and filtrate connectors of haemoconcentrators.10
4.6 Performance characteristics .11
4.6.1 Solute clearance for haemodialysers and haemodiafilters .11
4.6.2 Sieving coefficients for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators .11
4.6.3 Ultrafiltration rate .11
4.6.4 Ultrafiltration coefficient .11
4.6.5 Blood compartment volume .11
4.6.6 Blood compartment pressure drop .11
4.6.7 Endotoxin transfer of haemodialysers and haemodiafilters . 12
4.7 Expiry date . 12
5 Test methods .12
5.1 General . 12
5.2 Biological safety and haemocompatibility . 13
5.3 Sterility . 13
5.4 Non-pyrogenicity . 13
5.5 Mechanical characteristics . 13
5.5.1 Structural integrity. 13
5.5.2 Blood compartment integrity .14
5.5.3 Connectors .14
5.6 Performance characteristics .18
5.6.1 Solute clearance of haemodialysers and haemodiafilters .18
5.6.2 Sieving coefficient of haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators .21
5.6.3 Ultrafiltration rate . 23
5.6.4 Ultrafiltration coefficient . 23
5.6.5 Blood compartment volume .24
5.6.6 Blood compartment pressure drop .24
5.6.7 Endotoxin transfer of haemodialysers and haemodiafilters .24
6 Expiry date .24
7  Labelling .25
7.1 Labelling on the device. 25
7.2 Labelling on unit container . 25
7.3 Labelling on the outer container . 26
7.4 Information to be given in the accompanying documentation . 26

iii
ISO/FDIS 8637-1:2026(en)
8  Packaging.28
Annex A (informative)  Endotoxin transfer assessment .29
Annex B (informative)  Rationale for the introduction of  changes in mechanical characteristics
(structural integrity) .33
Bibliography .34

iv
ISO/FDIS 8637-1:2026(en)
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.
This third edition cancels and replaces the second edition (ISO 8637-1:2024), which has been technically
revised.
The main changes are as follows:
[1]
— addition of the link to ISO 14971 for risk management procedures;
— alignment of terms and definitions with those defined in other parts of the ISO 8637 series;
— revision of the procedure to demonstrate the properties required by the standard for the specification
of the expiration date;
— introduction of an Annex B to explain the rationale for the changes relating to mechanical strength in the
context of regulatory requirements.
A list of all 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.

v
ISO/FDIS 8637-1:2026(en)
Introduction
This document is concerned with devices intended for haemodialysis, haemodiafiltration, haemofiltration
and haemoconcentration in humans. If such a device is used with an extracorporeal circuit, to minimize the
risk of accidental disconnection or the ingress of air, the dimensions of the blood ports and filtrate ports
have been specified to ensure compatibility of the device with the extracorporeal blood circuit specified in
[2]
ISO 8637-2 .
There is no intention to specify or set limits on the functional performance characteristics of the devices,
nor to specify the materials acceptable for manufacture. Such restrictions are unnecessary for the qualified
user and would limit the use of alternatives available when selecting a device for use ineed to a specific
application. All materials used for the manufacture of the device meet the necessary mechanical strength
requirements, and if in contact with blood, the necessary requirements relating to biocompatibility,
thrombogenicity and pyrogenicity after sterilization, and have been demonstrated as doing so. The testing
methods used and the test results are made available upon request.
The performance characteristics together with their methods of measurement have been revised and
updated to take into consideration developments in technology that have occurred since the publication of
the previous edition of this document.
The requirements specified in this document reflects the consensus of physicians, technologists,
manufacturers and other interested parties to ensure safety and satisfactory function.

vi
FINAL DRAFT International Standard ISO/FDIS 8637-1:2026(en)
Extracorporeal systems for blood purification —
Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1 Scope
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters
and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices,
— vascular access devices,
— blood pumps,
— systems to prepare, maintain or monitor dialysis fluid,
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration, and
— reprocessing procedures and equipment.
NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are
[2]
specified in ISO 8637-2 .
[3]
NOTE 2 Requirements for 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 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 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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/FDIS 8637-1:2026(en)
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 23500-5, Preparation and quality management of fluids for haemodialysis and related therapies — Part 5:
Quality of dialysis fluid 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 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
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
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
blood compartment
part of a haemodialyser (3.16), haemodiafilter (3.14), haemofilter (3.18) or haemoconcentrator (3.13) through
which blood is intended to pass
3.2
blood compartment volume
volume needed to fill the blood compartment (3.1)
Note 1 to entry: For hollow fibre devices, the blood compartment volume (3.2) includes the volume of the hollow fibres
plus the headers.
3.3
blood compartment connector
blood connector
DEPRECATED: blood port
cone type connector to permit the entry and exit of blood and to connect the device to blood tubing sets
3.4
clearance
volume of a solution from which a solute is completely removed per unit time
3.5
convection
transport of a solvent across a semipermeable membrane resulting from a pressure differential across the
membrane
Note 1 to entry: Convective solute transport supplements diffusive transport as a result of “solute drag” whereby
solutes contained in the solvent are co-transported with the solvent.

ISO/FDIS 8637-1:2026(en)
3.6
convective therapy
form of renal replacement therapy that removes uraemic toxins from blood either by convection (3.5) solely
or by a combination of diffusion (3.10) and convection (3.5) through a semipermeable membrane
Note 1 to entry: Convective therapies remove toxins from the blood by removing fluid from the device in excess of that
required to achieve the patient’s target fluid balance, thereby requiring infusion of replacement fluid into the patient’s
blood. In contrast, haemodialysis removes fluid from the device only to correct the patient’s fluid weight gain realized
between dialysis treatments.
Note 2 to entry: Haemofiltration and haemodiafiltration are types of convective therapies.
Note 3 to entry: Haemoconcentrators are fluid removal devices used during cardiac surgery.
3.7
dialysis fluid
dialysate
dialysis solution
dialysing fluid
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange solutes
with blood during haemodialysis (3.17) or haemodiafiltration (3.15)
Note 1 to entry: The term “dialysis fluid” is used throughout this document to mean the fluid (made from dialysis
water and concentrates) which is delivered to the haemodialyser or haemodiafilter by a dialysis fluid delivery system.
The dialysis fluid entering the haemodialyser or haemodiafilter can be referred as "fresh dialysis fluid", while the fluid
leaving the haemodialyser or haemodiafilter can be referred to as "spent dialysis fluid" or " dialysis effluent".
Note 2 to entry: Dialysis fluid does not include pre-packaged fluids used in some renal replacement therapies.
3.8
dialysis fluid compartment
part of a haemodialyser (3.16) or haemodiafilter (3.14) through which dialysis fluid (3.7) is intended to pass
3.9
dialysis fluid connector
dialysate connector
connector forming part of the device to permit the passage of dialysis fluid through the device and to link
the device to equipment producing the dialysis fluid
3.10
diffusion
transport of solutes across a semipermeable membrane, caused by a concentration gradient
3.11
filtrate
fluid removed from the blood across the semipermeable membrane contained in a haemodialyser (3.16),
haemodiafilter (3.14), haemofilter (3.18) or haemoconcentrator (3.13), due to a pressure gradient (including
the contributions of both hydrostatic and oncotic pressures) across the semipermeable membrane
Note 1 to entry: In a haemodialyser and haemodiafilter, the fluid removed is mixed with dialysis fluid flowing through
the device.
3.12
haemoconcentration
convective process with the purpose of removing excess plasma water from the patient’s blood volume, that
has been expanded by physiologic fluid, as typically required during cardiac surgery
3.13
haemoconcentrator
device intended to perform haemoconcentration (3.12)

ISO/FDIS 8637-1:2026(en)
3.14
haemodiafilter
device intended to perform haemodiafiltration (3.15)
3.15
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 haemodialysis (3.17) and haemofiltration (3.19)
Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid stream as in haemodialysis. 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).
[4]
[SOURCE: IEC 60601-2-16 , 201.3.209, modified — Note 1 to entry has been added.]
3.16
haemodialyser
device intended to perform haemodialysis (3.17)
3.17
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 semipermeable
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.
[4]
[SOURCE: IEC 60601-2-16 , 201.3.210]
3.18
haemofilter
device intended to perform haemofiltration (3.19)
3.19
haemofiltration
HF
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 resulting in the required net fluid removal
[4]
[SOURCE: IEC 60601-2-16 , 201.3.212]
Note 1 to entry: In haemofiltration, there is no dialysis fluid stream.
3.20
labelling
written, printed, graphic or electronic matter that is affixed to a device (haemodialyser, haemodiafilter,
haemofilter or haemoconcentrator) or any of its containers or wrappers, or accompanies a device and which
is related to identification, technical description and use of that device, but excluding shipping documents
3.21
sieving coefficient
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in the
plasma
ISO/FDIS 8637-1:2026(en)
3.22
transmembrane pressure
TMP
p
TM
mean pressure exerted across a semipermeable membrane
Note 1 to entry: For practical reasons, the mean TMP is generally expressed as either
— the difference between arithmetic means of inlet and outlet pressures of the blood and dialysis fluid compartments
of a haemodialyser or a haemodiafilter, or
— the difference between the arithmetic mean of the inlet and outlet pressures of the blood compartment and the
filtrate pressure of a haemofilter or a haemoconcentrator.
3.23
ultrafiltration
UF
pressure driven process employing a hydraulic pressure gradient applied to a semipermeable membrane, to
facilitate excess fluid removal from the patient
3.24
ultrafiltration coefficient
permeability of the device to plasma water
Note 1 to entry: The ultrafiltration coefficient is generally expressed in millilitres per hour per millimetre of mercury.
3.25
ultrafiltration rate
UFR
filtrate flow rate from the blood compartment to the dialysis fluid compartment caused by a pressure
gradient or pressure differential across the membrane measured as volume per time
Note 1 to entry: Ultrafiltration rate is expressed in ml/min or l/h.
4  Requirements
4.1  General
This clause gives the requirements for the device, the evaluation of which shall conform to a structured
evaluation plan within a risk management process in accordance with ISO 14971.
4.2  Biological safety and haemocompatibility
Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for
freedom from biological hazards, in accordance with 5.2. If the device is labelled for reuse, testing shall be
performed after reprocessing following the manufacturer's instructions for use.
Attention is drawn to the need to establish whether national regulations or national standards governing
toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable,
in the countries in which the device is to be marketed.
4.3 Sterility
The blood pathway of the device shall be sterile and the state of sterility of the device shall conform with the
manufacturer's statement [see 7.2, list item h)].
Conformity shall be verified in accordance with 5.3.

ISO/FDIS 8637-1:2026(en)
4.4  Non-pyrogenicity
The blood pathway of the device shall be non-pyrogenic and the state of non-pyrogenicity of the device shall
conform with the manufacturer's statement [see 7.2, list item h)].
Conformity shall be verified in accordance with 5.4.
4.5  Mechanical characteristics
4.5.1  Structural integrity
The device external casing 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 foreseeable misuse. For basic safety, single failure shall also be considered in
the assessment. (See Annex B for further guidance). Alternatively use the maximum pressure recommended
by the manufacturer to verify structural integrity .
Conformity shall be verified in accordance with 5.5.1.2 and 5.5.1.3.
4.5.2  Blood compartment integrity
When exposing the blood compartment of the device to a validated test procedure performed at the
maximum pressure derived from the manufacturer’s risk management process, the blood compartment
shall not leak. Test times and pressures can be determined based on the results of the product-specific risk
management. Considerations include, but are not limited to, the type of application, duration of treatment,
pressures and temperatures encountered, and foreseeable misuse. For basic safety, single failure shall also
be considered in the assessment. Alternatively the maximum pressure recommended by the manufacturer
to verify structural integrity can be used.
Conformity with this requirement shall be verified when tested in accordance with 5.5.2.
4.5.3  Haemodialysers, haemodiafilters and haemofilters  blood compartment connectors
4.5.3.1  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 minimum separation force, minimum
separation torque and maximum connection torque 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.
4.5.3.2  Dimensional requirements
Except where the device and the extracorporeal blood circuit are designed as an integral system, the
dimensions of the blood compartment connector shall be as given in Figure 1 and Table 1.
Conformity with this requirement shall be verified in accordance with 5.5.3.2.

ISO/FDIS 8637-1:2026(en)
Figure 1 — Cone blood inlet and outlet blood compartment connector of haemodialysers,
haemodiafilters or haemofilters

ISO/FDIS 8637-1:2026(en)
Table 1 — Dimensions of the blood compartment connector
a b c d
E F G H J K P α β γ
mm mm mm mm mm mm mm ° °
Minimum 10,8 0,85 5,97 — —
10 or 9 or 13 or
Nominal 8 11,0 1,10 6,00 15 15 6:100
more more more
Maximum 11,3 1,35 6,03 — —
Key
E length of tapered region
F length of tapered region
G thread pitch
H root diameter
J crest diameter
K thread crest width
P cone diameter
α angle of thread
β angle of thread
γ dimension taper rate
a
Double thread pitch.
b
Altered upper tolerance to accommodate different components and materials.
c
Revised dimension and tolerances based on existing manufacturing practice.
d
Cone's plane of reference: square A. This dimension is measured as a projection on the front face. See Figure 1 (Z).
4.5.4  Haemodialyser and haemodiafilter dialysis fluid compartment connectors
4.5.4.1  General
All connectors that connect haemodialysers, haemodiafilters, haemofilters or haemoconcentrators to the
dialysis circuit shall provide a safe and leak-free connection. Ingress of air from the outside or the leakage of
dialysis fluid to the environment shall be avoided. The selected forces required to make the connection shall
be representative of the typical physical conditions of users. If necessary, occupational health and safety
guidelines for maximum permissible forces should be taken into account.
4.5.4.2  Dimensional requirements
Except where the haemodialyser or haemodiafilter and the dialysis fluid circuit are designed as an integral
system, the dimensions of the dialysis fluid compartment connectors shall be as given in Figure 2 and
Table 2.
Conformity with this requirement shall be verified in accordance with 5.5.3.3.

ISO/FDIS 8637-1:2026(en)
Figure 2 — Main fitting dimensions of the dialysis fluid inlet and outlet connector
Table 2 — Main fitting dimensions of the dialysis fluid inlet and outlet connector
a b
E F G H J K P S α β X
mm mm mm mm mm mm mm ° ° °
Minimum 10,1 13,0 17,8 14,8 12,3 12,0
22 or
Nominal 10,2 13,1 17,8 0,5 14,9 12,4 12,1 45 45 45
more
Maximum 10,3 13,2 18,1 14,9 12,5 12,2
Key
E testing length
F reference length
G testing length range
H cone diameter
J cone diameter
K cone diameter
P diameter
S diameter
α angle of sealing surface
β angle of sealing surface
X angle of sealing surface
a
It defines the necessary length and diameter for engagement with the socket connectors of dialysis fluid circuit.
b
Together with α, it defines diameter of the sealing surface for the dialysis fluid connectors.

ISO/FDIS 8637-1:2026(en)
4.5.5  Filtrate connectors of haemofilters
4.5.5.1  General
All connectors that connect the filtrate connectors of haemofilters to the extracorporeal filtrate circuit shall
provide a safe connection. To ensure a safe connection, leakage of air from the outside or loss of fluid to the
environment shall be avoided. The selected forces required to make the connection shall be representative of
the typical physical conditions of users. If necessary, occupational health and safety guidelines for maximum
permissible forces should be taken into account.
4.5.5.2  Dimensional requirements
Except where the haemofilter and the filtrate circuit are designed as an integral system, the filtrate
connectors of haemofilters shall follow either
a) the design of Figure 2, or
b) the Luer lock connector design of ISO 80369-7:2021, Figures B.1 and B.3.
Conformity with this requirement shall be verified in accordance with 5.5.3.4.
4.5.6  Blood and filtrate connectors of haemoconcentrators
4.5.6.1  Blood connectors
The blood and filtrate connectors of haemoconcentrators shall allow for a secure connection to the tubing
which shall be used with the device.
Non-locking connectors shall not separate under an axial force of 25 N applied for 15 s.
Except where the device and the extracorporeal blood circuit are designed as an integral system, the
dimensions of the blood compartment connectors shall be as given in Figure 1 and Table 1.
Dimensional conformity shall be determined using any one or combination of the following: digital contact
measurement instruments, optical measurement, three-dimensional X-ray imaging, analogue gauges or
another validated method. The dimensional conformity assessment may involve destructive methods to
gain access to features for measurement.
Conformity with this requirement shall be verified in accordance with 5.5.3.5.
4.5.6.2  Filtrate connectors
4.5.6.2.1  General
All connectors that connect the flitrate connectors of haemofilters to the extracorporeal filtrate circuit shall
provide a safe connection. To ensure a safe connection, leakage of air from the outside or loss of fluid to the
environment shall be avoided. The selected forces required to make the connection shall be representative of
the typical physical conditions of users. If necessary, occupational health and safety guidelines for maximum
permissible forces should be taken into account.
4.5.6.2.2  Dimensional requirements
Except where the haemoconcentrators are designed as an integral system, the filtrate connector design
shall follow
a) the design of Figure 2,
b) the non-locking connection for direct attachment of the tubing, or
c) the Luer lock connector design of ISO 80369-7:2021, Figures B.1 and B.3.

ISO/FDIS 8637-1:2026(en)
If non-locking connectors are used, they shall not separate under an axial force of 25 N applied for 15 s.
Conformity with this requirement shall be verified in accordance with 5.5.3.5.
4.6  Performance characteristics
4.6.1  Solute clearance for haemodialysers and haemodiafilters
The clearance of urea, creatinine, phosphate and vitamin B12 shall be determined in accordance with 5.6.1.
Blood and dialysis fluid flow rates shall cover the manufacturer's specified range.
NOTE As a supplement, urea mass transfer area coefficient (KoA) results are included.
4.6.2  Sieving coefficients for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
For haemodialysers, haemodiafilters and haemofilters, the sieving coefficients (SCs) for albumin, inulin, and
β -microglobulin or myoglobin shall be determined in accordance with 5.6.2.
Additionally, the following middle molecular weight proteins are of known clinical interest and represent a
range of molecular weights across the middle molecular spectrum. The manufacturer can choose to report
the SC for either these compounds or other middle molecular proteins, or both, to provide performance
characteristics if the SC for these proteins is larger than or equal to 0,1:
— kappa free light chains (κ-FLC, 23 kDa);
— complement factor D (CFD, 24 kDa);
— alpha 1-microglobulin (α1-M, 33 kDa);
— chitinase-3-like-protein 1 (YKL-40, 40 kDa);
— lambda free light chains (λ-FLC, 45 kDa).
For haemoconcentrators, the sieving coefficient for albumin shall be determined in accordance with 5.6.2.
4.6.3  Ultrafiltration rate
The ultrafiltration rate shall be determined if the device is intended for convective therapies in accordance
with 5.6.3.
4.6.4  Ultrafiltration coefficient
The ultrafiltration coefficient shall be determined in accordance with 5.6.4.
4.6.5  Blood compartment volume
The volume of the blood compartment shall be determined in accordance with 5.6.5.
If the blood compartment volume is stable or constant over the clinical range of pressures, a single
measurement is sufficient. If the blood compartment volume varies with pressure, the blood compartment
volume over the clinical range of pressures shall be established.
4.6.6  Blood compartment pressure drop
The pressure drop of the blood compartment shall be determined in accordance with 5.6.6.

ISO/FDIS 8637-1:2026(en)
4.6.7  Endotoxin transfer of haemodialysers and haemodiafilters
The manufacturer shall determine that the risk to the patient is acceptable regarding pyrogenic response
due to endotoxin transfer between the dialysis fluid pathway and the blood fluid pathway during preparation
and therapy, and considering the results of endotoxin transfer testing.
Conformity with this requirement shall be verified in accordance with 5.6.7.
4.7 Expiry date
The biological safety, sterility, performance data and mechanical integrity of the device shall be proven after
storage for a period corresponding to the expiry date.
Conformity shall be verified in accordance with Clause 6.
5 Test methods
5.1  General
The requirements specified in Clause 4 shall be determined prior to marketing a new type of device and
shall be re-evaluated after changes in the device that can alter its performance.
If labelled for multiple uses, devices shall be tested for structural integrity, biological safety and performance
after reprocessing in accordance with the manufacturer's instructions to characterize the effects of the
recommended cleaning agent and germicide on membrane performance.
For the tests, device sample size shall be risk based and shall be capable of demonstrating that the test
results meet the full range of specifications of the manufacturer with statistical confidence.
Configuration of the disposable samples used for the tests shall be representative of the final production
configuration, including sterilization.
Measurements shall be made in vitro at (37 ± 1) °C. When the relationship between variables is non linear,
sufficient determinations shall be made to permit interpolation between the data points. The techniques of
measurement given in this document are reference tests. Other test methods may be used, provided they
have been validated and shown to be precise and reproducible.
The test systems shown do not indicate all the necessary details of a practicable test apparatus. The design
and construction of actual test systems and the establishment of actual test systems shall also address
factors contributing to measurement error, including, but not limited to
— pressur
...

ISO/TC 150/SC 2
Secretariat: ANSI
Date: 2026-06-30xx
Extracorporeal systems for blood purification —
Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
Systèmes extracorporels pour la purification du sang —
Partie 1: Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
FDIS stage
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 6
4.1 General . 6
4.2 Biological safety and haemocompatibility . 6
4.3 Sterility . 6
4.4 Non-pyrogenicity . 6
4.5 Mechanical characteristics . 6
4.6 Performance characteristics . 11
4.7 Expiry date . 12
5 Test methods . 12
5.1 General . 12
5.2 Biological safety and haemocompatibility . 13
5.3 Sterility . 13
5.4 Non-pyrogenicity . 14
5.5 Mechanical characteristics . 14
5.6 Performance characteristics . 20
6 Expiry date . 25
7 Labelling . 25
7.1 Labelling on the device . 25
7.2 Labelling on unit container . 26
7.3 Labelling on the outer container . 27
7.4 Information to be given in the accompanying documentation . 27
8 Packaging . 29
Annex A (informative) Endotoxin transfer assessment . 30
Annex B (informative) Rationale for the introduction of changes in mechanical characteristics
(structural integrity) . 34
Bibliography . 35

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.
This third edition cancels and replaces the second version of this documentedition (ISO 8637-1:2024), which
has been technically revised.
The main changes are as follows:
[24]
— addition of the link to ISO 14971 ISO 14971 for risk management procedures;
— alignment of terms and definitions with those defined in other parts of the ISO 8637 series;
— revision of the procedure to demonstrate the properties required by the standard for the specification of
the expiration date;
— introduction of an Annex B to explain the rationale for the changes relating to mechanical strength in the
context of regulatory requirements.
A list of all 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 devices intended for haemodialysis, haemodiafiltration, haemofiltration and
haemoconcentration in humans. If such a device is used with an extracorporeal circuit, to minimize the risk of
accidental disconnection, or the ingress of air, the dimensions of the blood ports and filtrate ports have been
[2]
specified to ensure compatibility of the device with the extracorporeal blood circuit specified in ISO 8637-2 .
There is no intention to specify, or set limits on the functional performance characteristics of the devices, nor
to specify the materials acceptable for manufacture. Such restrictions are un necessaryunnecessary for the
qualified user and would limit the use of alternatives available when selecting a device for use ineed to a
specific application. All materials used for the manufacture of the device meet the necessary mechanical
strength requirements, and if in contact with blood, the necessary requirements relating to biocompatibility,
thrombogenicity, and pyrogenicity after sterilization,., and have been demonstrated as doing so. The testing
methods used and the test results are made available upon request.
The performance characteristics together with their methods of measurement have been revised and updated
to take into consideration developments in technology that have occurred since the publication of the previous
edition of this document.
The requirements specified in this document reflects the consensus of physicians, technologists,
manufacturers and other interested parties to ensure safety and satisfactory function.
v
Extracorporeal systems for blood purification —
Part 1:
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1 Scope
This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters
and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;,
— vascular access devices;,
— blood pumps;,
— systems to prepare, maintain or monitor dialysis fluid;,
— systems or equipment intended to perform haemodialysis, haemodiafiltration;, haemofiltration or
haemoconcentration;, and
— reprocessing procedures and equipment.
NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are
[2]
specified in ISO 8637-2 .
[3]
NOTE 2 Requirements for 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 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 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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 14971, Medical devices — Application of risk management to medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 20417, Medical devices — Information to be supplied by the manufacturer
ISO 23500-5, Preparation and quality management of fluids for haemodialysis and related therapies — Part 5:
Quality of dialysis fluid 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 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
EN ISO 23500-5:2024, Preparation and quality management of fluids for haemodialysis and related therapies -
Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
ANSI/AAMI RD16 Cardiovascular implants and artificial organs - Hemodialysers, hemodiafilters, hemofilters
and hemoconcentrators
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
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
blood compartment, noun
part of a haemodialyser (3.16), haemodiafilter (3.14), haemofilter (3.18) or haemoconcentrator (3.13) through
which blood is intended to pass
3.2
blood compartment volume, noun
volume which is needed to fill the blood compartment (3.1)
Note 1 to entry: For hollow fibre devices, the blood compartment volume (3.2) includes the volume of the hollow fibres
plus the headers.
3.3
blood compartment connector, noun
blood connector, noun
DEPRECATED: blood port
cone type connector to permit the entry and exit of blood and to connect the device to blood tubing sets
3.4
clearance, noun
volume of a solution from which a solute is completely removed per unit time
3.5
convection, noun
transport of a solvent across a semipermeable membrane resulting from a pressure differential across the
membrane
Note 1 to entry: Convective solute transport supplements diffusive transport as a result of “solute drag” whereby solutes
contained in the solvent are co-transported with the solvent.
3.6
convective therapy, noun
form of renal replacement therapy that removes uremicuraemic toxins from blood either by convection (3.5)
solely or by a combination of diffusion (3.10) and convection (3.5) through a semipermeable membrane
Note 1 to entry: Convective therapies remove toxins from the blood by removing fluid from the device in excess of that
required to achieve the patient’s target fluid balance, thereby requiring infusion of replacement fluid into the patient’s
blood. In contrast, haemodialysis removes fluid from the device only to correct the patient’s fluid weight gain realized
between dialysis treatments.
Note 2 to entry: Haemofiltration and haemodiafiltration are types of convective therapies.
Note 3 to entry: Haemoconcentrators are fluid removal devices used during cardiac surgery.
3.7
dialysis fluid, noun
dialysate, noun
dialysis solution, noun
dialysing fluid, noun
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange solutes
with blood during haemodialysis (3.17) or haemodiafiltration (3.15)
Note 1 to entry: The term “dialysis fluid” is used throughout this document to mean the fluid (made from dialysis water
and concentrates) which is delivered to the haemodialyser or haemodiafilter by a dialysis fluid delivery system. The
dialsisdialysis fluid entering the haemodialyser or haemodiafilerhaemodiafilter can be refferedreferred as "fresh dialysis
fluid", while the fluid leaving the haemodialyser or haemodifliterhaemodiafilter can be referred to as "spent dialysis fluid"
or " dialysis effluent".
Note 2 to entry: Dialysis fluid does not include pre-packaged fluids used in some renal replacement therapies.
3.8
dialysis fluid compartment, noun
part of a haemodialyser (3.16) or haemodiafilter (3.14) through which dialysis fluid (3.7) is intended to pass
3.9
dialysis fluid connector, noun
dialysate connector, noun
connector forming part of the device to permit the passage of dialysis fluid through the device and to link the
device to equipment producing the dialysis fluid
3.10
diffusion, noun
transport of solutes across a semipermeable membrane, caused by a concentration gradient
3.11
filtrate, noun
fluid removed from the blood across the semipermeable membrane contained in a haemodialyser (3.16),
haemodiafilter (3.14), haemofilter (3.18) or haemoconcentrator (3.13), due to a pressure gradient (including
the contributions of both hydrostatic and oncotic pressures) across the semipermeable membrane
Note 1 to entry: In a haemodialyser and haemodiafilter, the fluid removed is mixed with dialysis fluid flowing through
the device.
3.12
haemoconcentration, noun
convective process with the purpose of removing excess plasma water from the patient’s blood volume, that
has been expanded by physiologic fluid, as typically required during cardiac surgery
3.13
haemoconcentrator, noun
device intended to perform haemoconcentration (3.12)
3.14
haemodiafilter, noun
device intended to perform haemodiafiltration (3.15)
3.15
haemodiafiltration, noun
HDF, noun
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 (3.17) and haemofiltration (3.19)
Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid stream as in haemodialysis. 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).
[4]
[SOURCE: IEC 60601-2-16 ,, 201.3.209, modified — Note 1 to entry has been added.]
3.16
haemodialyser, noun
device intended to perform haemodialysis (3.17)
3.17
haemodialysis, noun
HD, noun
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 semipermeable
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.
[4]
[SOURCE: IEC 60601-2-16 ,, 201.3.210]
3.18
haemofilter, noun
device intended to perform haemofiltration (3.19)
3.19
haemofiltration, noun
HF, noun
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
resulting in the required net fluid removal
[4]
[SOURCE: IEC 60601-2-16 ,, 201.3.212]
Note 1 to entry: In haemofiltration, there is no dialysis fluid stream.
3.20
labelling, noun
written, printed, graphic or electronic matter that is affixed to a device (haemodialyser, haemodiafilter,
haemofilter or haemoconcentrator) or any of its containers or wrappers, or accompanies a device and which
is related to identification, technical description and use of that device, but excluding shipping documents
3.21
sieving coefficient, noun
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in the plasma
3.22
transmembrane pressure, noun
TMP, noun
p , noun
TM
mean pressure exerted across a semipermeable membrane
Note 1 to entry: For practical reasons, the mean TMP is generally expressed as either:
— the difference between arithmetic means of inlet and outlet pressures of the blood and dialysis fluid compartments
of a haemodialyser or a haemodiafilter;, or
— the difference between the arithmetic mean of the inlet and outlet pressures of the blood compartment and the
filtrate pressure of a haemofilter or a haemoconcentrator.
3.23
ultrafiltration, noun
UF, noun
pressure driven process employing a hydraulic pressure gradient applied to a semipermeable membrane, to
facilitate excess fluid removal from the patient
3.24
ultrafiltration coefficient, noun
permeability of the device to plasma water
Note 1 to entry: The ultrafiltration coefficient is generally expressed in millilitres per hour per millimetre of mercury.
3.25
ultrafiltration rate, noun
UFR, noun
filtrate flow rate from the blood compartment to the dialysis fluid compartment caused by a pressure gradient
or pressure differential across the membrane measured as volume per time
Note 1 to entry: Ultrafiltration rate is expressed in ml/min or l/h.
4 Requirements
4.1 General
This clause gives the requirements for the device, the evaluation of which shall conform to a structured
evaluation plan within a risk management process in accordance with .ISO 14971.
4.2 Biological safety and haemocompatibility
Parts of the device that are intended to come into direct or indirect contact with blood shall be evaluated for
freedom from biological hazards, in accordance with 5.2. If the device is labelled for reuse, testing shall be
performed after reprocessing following the manufacturer's instructions for use.
Attention is drawn to the need to establish whether national regulations or national standards governing
toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable,
in the countries in which the device is to be marketed.
4.3 Sterility
The blood pathway of the device shall be sterile and the state of sterility of the device shall conform with the
manufacturer's statement [see 7.2, list item h).
Conformity shall be verified in accordance with 5.3.
4.4 Non-pyrogenicity
The blood pathway of the device shall be non-pyrogenic and the state of non-pyrogenicity of the device shall
complyconform with the manufacturer's statement [see 7.2, list item h).
ComplianceConformity shall be verified in accordance with 5.4.
4.5 Mechanical characteristics
4.5.1 Structural integrity
The device external casing 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 foreseeable misuse. For basic safety, single failure shall also be considered in
the assessment. (See Annex B for further guidance). Alternatively use the maximum pressure recommended
by the manufacturer to verify structural integrity .
Conformity shall be verified in accordance with 5.5.1.2 and 5.5.1.3.
4.5.2 Blood compartment integrity
When exposing the blood compartment of the device to a validated test procedure performed at the maximum
pressure derived from the manufacturer’s risk management process, the blood compartment shall not
leak. Test times and pressures can be determined based on the results of the product-specific risk
management. Considerations include, but are not limited to, the type of application, duration of treatment,
pressures and temperatures encountered, and foreseeable misuse. For basic safety, single failure mustshall
also be considered in the assessment. Alternatively the maximum pressure recommended by the
manufacturer to verify structural integrity can be used.
Conformity with this requirement shall be verified when tested in accordance with 5.5.2.
4.5.3 Haemodialysers, haemodiafilters and haemofilters blood compartment connectors
4.5.3.1 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 minimum separation force, minimum
separation torque and maximum connection torque 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.
4.5.3.2 Dimensional requirements
Except where the device and the extracorporeal blood circuit are designed as an integral system, the
dimensions of the blood compartment connector ns shall be as given in Figure 1 and Table 1.
ComplianceConformity with this requirement shall be verified in accordance with 5.5.3.2.
Figure 1 — Cone blood inlet and outlet blood compartment connector of haemodialysers,
haemodiafilters or haemofilters
Table 1 — Dimensions of the blood compartment connector
a b c d
E F G H J K P α β γ
mm mm mm mm mm mm mm ° °
Minimum 10,8 0,85 5,97 — —
10 or 13 or
Nominal 9 or more 8 11,0 1,10 6,00 15 15 6:100
more more
Maximum 11,3 1,35 6,03 — —
Key
E length of tapered region
F length of tapered region
G thread pitch
H root diameter
J crest diameter
K thread crest width
P cone diameter
α angle of thread
β angle of thread
a b c d
E F G H J K P α β γ
mm mm mm mm mm mm mm ° °
γ dimension taper rate
a
Double thread pitch.
b
Altered upper tolerance to accommodate different components and materials.
c
Revised dimension and tolerances based on existing manufacturing practice.
d
Cone's plane of reference: square A. This dimension is measured as a projection on the front face. See Figure 1 (Z).
4.5.4 Haemodialyser and haemodiafilter dialysis fluid compartment connectors
4.5.4.1 General
All connectors that connect haemodialysers, haemodiafilters, haemofilters or haemoconcentrators to the
dialysis circuit shall provide a safe and leak-free connection. Ingress of air from the outside or the leakage of
dialysis fluid to the environment shall be avoided. The selected forces required to make the connection shall
be representative of the typical physical conditions of users. If necessary, occupational health and safety
guidelines for maximum permissible forces should be taken into account.
4.5.4.2 Dimensional requirements
Except where the haemodialyser or haemodiafilter and the dialysis fluid circuit are designed as an integral
system, the dimensions of the dialysis fluid compartment connectors shall be as given in Figure 2 and Table 2.
ComplianceConformity with this requirement shall be verified in accordance with 5.5.3.3.

Figure 2 — Main fitting dimensions of the dialysis fluid inlet and outlet connector
Table 2 — Main fitting dimensions of the dialysis fluid inlet and outlet connector
a b
E F G H J K P S α β X
mm mm mm mm mm mm mm ° ° °
Minimum 10,1 13,0 17,8 14,8 12,3 12,0
22 or
Nominal 10,2 13,1 17,8 0,5 14,9 12,4 12,1 45 45 45
more
Maximum 10,3 13,2 18,1 14,9 12,5 12,2
Key
E testing length
F reference length
G testing length range
H cone diameter
J cone diameter
K cone diameter
P diameter
S diameter
α angle of sealing surface
β angle of sealing surface
X angle of sealing surface
a
It defines the necessary length and diameter for engagement with the socket connectors of dialysis fluid circuit.
b
Together with α, it defines diameter of the sealing surface for the dialysis fluid connectors.
4.5.5 Filtrate connectors of haemofilters
4.5.5.1 General
All connectors that connect the filtrate connectors of haemofilters to the extracorporeal filtrate circuit shall
provide a safe connection. To ensure a safe connection, leakage of air from the outside or loss of fluid to the
environment shall be avoided. The selected forces required to make the connection shall be representative of
the typical physical conditions of users. If necessary, occupational health and safety guidelines for maximum
permissible forces should be taken into account.
4.5.5.2 Dimensional requirements
Except where the haemofilter and the filtrate circuit are designed as an integral system, the filtrate connectors
of haemofilters shall follow either
a) the design of Figure 2, or
b) the Luer lock connector design of ISO 80369-7:2021, Figures B.1 and B.3.
ComplianceConformity with this requirement shall be verified in accordance with 5.5.3.4.
4.5.6 Blood and filtrate connectors of haemoconcentrators
4.5.6.1 Blood connectors
The blood and filtrate connectors of haemoconcentrators shall allow for a secure connection to the tubing
which is toshall be used with the device.
Non-locking connectors shall not separate under an axial force of 25 N applied for 15 s.
Except where the device and the extracorporeal blood circuit are designed as an integral system, the
dimensions of the blood compartment connectors shall be as given in Figure 1 and Table 1.
Dimensional complianceconformity shall be determined using any one or combination of the following: digital
contact measurement instruments, optical measurement, three-dimensional X-ray imaging, analogue gauges
or another validated method. The dimensional complianceconformity assessment may involve destructive
methods to gain access to features for measurement.
ComplianceConformity with this requirement shall be verified in accordance with 5.5.3.5.
4.5.6.2 Filtrate connectors
4.5.6.2.1 General
All connectors that connect the flitrate connectors of haemofilters to the extracorporeal filtrate circuit shall
provide a safe connection. To ensure a safe connection, leakage of air from the outside or loss of fluid to the
environment shall be avoided. The selected forces required to make the connection shall be representative of
the typical physical conditions of users. If necessary, occupational health and safety guidelines for maximum
permissible forces should be taken into account.
4.5.6.2.2 Dimensional Requirementsrequirements
Except where the haemoconcentrators are designed as an integral system, the filtrate connector design shall
follow
a) the design of Figure 2, or
b) the non-locking connection for direct attachment of the tubing, or
c) the Luer lock connector design of ISO 80369-7:2021, Figures B.1 and B.3.
If non-locking connectors are used, they shall not separate under an axial force of 25 N applied for 15 s.
ComplianceConformity with this requirement shall be verified in accordance with 5.5.3.5.
4.6 Performance characteristics
4.6.1 Solute clearance for haemodialysers and haemodiafilters
The clearance of urea, creatinine, phosphate and vitamin B12 shall be determined in accordance with 5.6.1.
Blood and dialysis fluid flow rates shall cover the manufacturer's specified range.
NOTE As a supplement, urea mass transfer area coefficient (KoA) results are included.
4.6.2 Sieving coefficients for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
For haemodialysers, haemodiafilters and haemofilters, the sieving coefficients (SCs) for albumin, inulin, and
β -microglobulin or myoglobin shall be determined in accordance with 5.6.2.
Additionally, the following middle molecular weight proteins are of known clinical interest and represent a
range of molecular weights across the middle molecular spectrum. The manufacturer can choose to report the
SC for either these compounds or other middle molecular proteins, or both, to provide performance
characteristics if the SC for these proteins is larger than or equal to 0,1:
— kappa free light chains (κ-FLC, 23 kDa);
— complement factor D (CFD, 24 kDa);
— alpha 1-microglobulin (α1-M, 33 kDa);
— chitinase-3-like-protein 1 (YKL-40, 40 kDa);
— lambda free light chains (λ-FLC, 45 kDa).
For haemoconcentrators, the sieving coefficient for albumin shall be determined in accordance with 5.6.2.
4.6.3 Ultrafiltration rate
The ultrafiltration rate shall be determined if the device is intended for convective therapies in accordance
with 5.6.3.
4.6.4 Ultrafiltration coefficient
The ultrafiltration coefficient shall be determined in accordance with 5.6.4.
4.6.5 Blood compartment volume
The volume of the blood compartment shall be determined in accordance with 5.6.5.
If the blood compartment volume is stable or constant over the clinical range of pressures, a single
measurement is sufficient. If the blood compartment volume varies with pressure, the blood compartment
volume over the clinical range of pressures shall be established.
4.6.6 Blood compartment pressure drop
The pressure drop of the blood compartment shall be determined in accordance with 5.6.6.
4.6.7 Endotoxin transfer of haemodialysers and haemodiafilters
The manufacturer shall determine that the risk to the patient is acceptable regarding pyrogenic response due
to endotoxin transfer between the dialysis fluid pathway and the blood fluid pathway during preparation and
therapy, and considering the results of endotoxin transfer testing.
ComplianceConformity with this requirement shall be verified in accordance with 5.6.7.
4.7 Expiry date
The biological safety, sterility, performance data and mechanical integrity of the device shall be proven after
storage for a period corresponding to the expiry date.
ComplianceConformity shall be verified in accordance with Clause 6.
5 Test methods
5.1 General
The requirements specified in Clause 4 shall be determined prior to marketing a new type of device and shall
be re-evaluated after changes in the device that can alter its performance.
If labelled for multiple uses, devices shall be tested for structural integrity, biological safety and performance
after reprocessing in accordance with the manufacturer's instructions to characterize the effects of the
recommended cleaning agent and germicide on membrane performance.
For the tests, device sample size shall be risk based and shall be capable of demonstrating that the test results
meet the full range of specifications of the manufacturer with statistical confidence.
Configuration of the disposable samples used for the tests shall be representative of the final production
configuration, including sterilization.
Measurements shall be made in vitro at (37 ± 1) °C. When the relationship between variables is nonlinearnon
linear, sufficient determinations shall be made to permit interpolation between the data points. The
techniques of measurement given in this document are reference tests. Other test methods may be used,
provided they have been validated and shown to be precise and reproducible.
The test systems shown do not indicate all the necessary details of a practicable test apparatus. The design
and construction of actual test systems and the establishment of actual test systems shall also address factors
contributing to measurement error, including, but not limited to:
— pressure measurement errors due to static head effects and dynamic pressure drops;,
— parameter stabilization time;,
— uncontrolled temperature variations at the non-constant flow rates;,
— pH;,
— degradation of test substances due to heat, light and time;,
— degassing of test fluids;,
— trapped air;, and
— system contamination by foreign material, algae and bacteria.
NOTE This clause contains tests that are of a type-testing nature, which are carried out prior to the marketing of a
new device or when changes are made to the device or its manufacturing processes. OthertestsOther tests in this clause
are of a quality control nature, which are repeated on a regular basis according to quality management system
requirements.
5.2 Biological safety and haemocompatibility
The biological safety of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators pathways
that are intended to come into direct or indirect contact with the patient's blood shall be evaluated on
— samples of each new type of device prior to its marketing, or
— after any change in the materials of construction of that type of device, or
— after any change in the method of sterilization.
If labelled for multiple use, testing shall demonstrate the safety of the device before first use and after
reprocessing in accordance with the manufacturer's instructions. Testing shall be carried out in accordance
with ISO 10993-1, ISO 10993-4, ISO 10993-7 or ISO 10993-11, as relevant.
5.3 Sterility
ComplianceConformity with 4.3 shall be verified by inspection of the records to show that the device has been
exposed to a sterilization process that has been validated in accordance with ISO 11737-2.
5.4 Non-pyrogenicity
ComplianceConformity with 4.4 shall be verified in accordance with ISO 10993-11.
[5]
NOTE ISO 10993-11 ISO 10993-11 does not specifically address the requirements for endotoxin mediated
[6]
pyrogenicity test methods but makes reference to .
5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.1.1 General
The requirements of 4.5.1 shall be verified by the test methods given in 5.5.1.2 and 5.5.1.3.
5.5.1.2 Structural integrity under a positive pressure
Completely fill the device with degassed water at (37 ± 1) °C. Seal all connectors except the connector to which
pressure is applied. Apply the maximum positive pressure that can occur in the haemodialysis system in
accordance with the outputs of the manufacturer’s risk management process or a positive air pressure
1,5 times of the manufacturer's recommended maximum pressure and seal the apparatus. After a period of
time derived from the manufacturer’s risk management process or at least 10 min, record the pressure and
visually examine the device for leaks.
Alternately, a constant air pressure (maximum positive pressure that can occur in the haemodialysis system
in accordance with the outputs of the manufacturer’s risk management process or 1,5 times of the
manufacturer’s recommended maximum pressure) can be applied and the device can be submerged in water
to test for air leakage.
Equivalent or superior tests may be used, if available.
NOTE If the exposure of the item under test to a pressure of 1,5 times the recommended pressure result in damage,
[7]
a variation described in ISO 80369-20:2024 ISO 80369-20, Annex J maycan be used.
5.5.1.3 Structural integrity under a negative pressure
Completely fill the device with degassed water at (37 ± 1) °C. Seal all connectors except the connector to which
pressure is applied. Place the device under sub-atmospheric pressure of the maximum negative pressure that
can occur in the haemodialysis system in accordance with the outputs of the manufacturer’s risk management
process or a negative pressure 1,5 times of the manufacturer's recommended maximum pressure. Seal the
apparatus. After a period of time derived from the manufacturer’s risk management process or at least 10 min,
record the pressure and visually examine the device for leaks.
Alternately, a constant negative air pressure of the maximum negative pressure that can occur in the
haemodialysis system in accordance with the outputs of the manufacturer’s risk management process or 1,5
times the manufacturer’s recommended maximum negative pressure can be applied and the device can be
submerged in water to test for water leakage.
Equivalent or superior tests may be used, if available.
5.5.2 Blood compartment integrity
ComplianceConformity to 4.5.2 shall be determined by review of the validation records for the test procedure.
5.5.3 Connectors
5.5.3.1 General
All connectors shall provide a safe connection. In the case of blood connectors, to ensure a safe connection,
excessive leakage of air from the outside or loss of blood to the environment shall be avoided and in the case
of dialysis fluid connectors, the ingress of air or the leakage of dialysis fluid shall be avoided.
The degree of acceptable leakage rate, minimum separation force, minimum separation torque and maximum
connection torque shall be defined in accordance with the manufacturer’s risk management process.
Boundary parameters used in tests such as torques, connection forces and disconnection forces as well as
holding times, ambient temperatures, mustshall be considered and defined as part of the manufacturer's
assessment for the use of the product.
5.5.3.2 Blood compartment connectors of haemodialysers, haemodiafilters and haemofilters
ComplianceConformity with 4.5.4 shall be determined by dimensional inspection meeting the requirements
of Figure 1 and Table 1.
Dimensional complianceconformity shall be determined using any oneanyone or a combination of the
following:
a) digital contact measurement instruments, ;
b) optical measurement, ;
c) three-dimensional X-ray imaging, ;
d) analogue gauges or ;
e) other validated
...