ISO 8637:2004
(Main)Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 8637:2004 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as 'the device', for use for humans. ISO 8637:2004 is not applicable to extracorporeal blood circuits, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysate, systems used to perform haemofiltration or haemoconcentration, reprocessing procedures and equipment. Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are specified in ISO 8638.
Implants cardiovasculaires et organes artificiels — Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8637
Second edition
2004-10-01
Cardiovascular implants and artificial
organs — Haemodialysers,
haemodiafilters, haemofilters and
haemoconcentrators
Implants cardiovasculaires et organes artificiels — Hémodialyseurs,
hémodiafiltres, hémofiltres et hémoconcentrateurs
Reference number
ISO 8637:2004(E)
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ISO 8637:2004(E)
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ISO 8637:2004(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 3
4.1 Biological safety . 3
4.2 Sterility . 4
4.3 Nonpyrogenicity . 4
4.4 Mechanical characteristics . 4
4.5 Performance characteristics . 5
4.6 Expiration date . 6
5 Test methods . 7
5.1 General . 7
5.2 Biological safety . 7
5.3 Sterility . 7
5.4 Nonpyrogenicity . 7
5.5 Mechanical characteristics . 8
5.6 Performance characteristics . 8
5.7 Expiration date . 14
6 Labelling . 14
6.1 Labelling on the device . 14
6.2 Labelling on the unit containers . 14
6.3 Labelling on the outer containers . 15
6.4 Accompanying documentation . 15
Bibliography . 17
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ISO 8637:2004(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8637 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants.
This second edition cancels and replaces the first edition (ISO 8637:1989), which has been technically revised.
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ISO 8637:2004(E)
Introduction
This International Standard is concerned with devices intended for haemodialysis, haemofiltration,
haemodiafiltration and haemoconcentration in humans. The requirements specified in this International
Standard will help to ensure their safety and satisfactory function.
lt was not found practicable to specify materials of construction. This International Standard therefore requires
only that materials have been tested and that the methods and results are made available upon request. There
is no intention to specify, or to set limits on, the performance characteristics of the devices because such
restrictions are unnecessary for the qualified user and would limit the alternatives available when choosing a
device for a specific application.
The dimensions of the blood ports and the dialysate or filtrate ports have been specified to ensure compatibility
of the device with the extracorporeal blood circuit specified in ISO 8638. The design and dimensions have been
selected in order to minimize the risk of leakage of blood and the ingress of air.
This International Standard reflects the consensus of physicians, manufacturers and other interested parties for
devices that are approved for clinical use. Conformance with the standard is voluntary and it does not
supersede any national regulation.
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INTERNATIONAL STANDARD ISO 8637:2004(E)
Cardiovascular implants and artificial organs —
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1Scope
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators, hereinafter collectively referred to as “the device”, for use for humans.
This lnternational Standard is not applicable to
— extracorporeal blood circuits,
— plasmafilters,
— haemoperfusion devices,
— vascular access devices,
— blood pumps,
— pressure monitors for the extracorporeal blood circuit,
— air detection devices,
— systems to prepare, maintain or monitor dialysate,
— systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration,
— reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are
specified in ISO 8638.
2 Normative references
The following referenced documents are indispensable for the application 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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 8638, Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
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
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ISO 8637:2004(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blood compartment
part of a haemodialyser, haemodiafilter, haemofilter or haemoconcentrator through which blood is intended to
pass
NOTE For hollow-fibre devices, the blood compartment includes the volume of the hollow fibres plus the headers.
3.2
clearance
volume of a solution from which a solute is completely removed per unit time
3.3
convection
transport of solutes across a semipermeable membrane, along with filtered fluid, caused by a pressure gradient
or pressure differential across the membrane
3.4
dialysate
dialysing fluid
solution which is intended to exchange solutes and/or water in blood during haemodialysis or haemodiafiltration
3.5
dialysate compartment
part of a haemodialyser or haemodiafilter through which dialysate is intended to pass
3.6
diffusion
transport of solutes across a semipermeable membrane, caused by a concentration gradient
3.7
filtrate
fluid removed from the blood across the semipermeable membrane into the dialysate or filtrate compartment of
a haemodialyser, haemodiafilter, haemofilter or haemoconcentrator, due to a pressure gradient across the
semipermeable membrane
3.8
haemoconcentration
process whereby plasma water and electrolytes are removed from diluted blood across a semipermeable
membrane
3.9
haemoconcentrator
device intended to perform haemoconcentration
3.10
haemodiafilter
device intended to perform haemodiafiltration
3.11
haemodiafiltration
process whereby solute imbalances in a patient's blood are corrected by means of simultaneous convection and
diffusion across a semipermeable membrane and replacement with an appropriate physiological fluid
NOTE Normally the process also includes a net fluid removal.
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ISO 8637:2004(E)
3.12
haemodialyser
device intended to perform haemodialysis
3.13
haemodialysis
process whereby solute imbalances in a patient's blood are corrected, mainly by diffusion across a
semipermeable membrane
NOTE Normally the process also includes a net fluid removal.
3.14
haemofilter
device intended to perform haemofiltration
3.15
haemofiltration
process whereby solute imbalances in a patient's blood are corrected, mainly by convection across a
semipermeable membrane and replacement with an appropriate physiological fluid
NOTE Normally the process also includes a net fluid removal.
3.16
labelling
written, printed, graphic or electronic matter which is
— affixed to a medical device or any of its containers or wrappers, or
— accompanying a medical device, and is related to identification, technical description and use of the medical
device, but excluding shipping documents
3.17
sieving coefficient
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in the plasma
3.18
transmembrane pressure
TMP
Differential pressure exerted across a semipermeable membrane
NOTE 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 dialysate 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.
4 Requirements
4.1 Biological safety
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 in accordance with the manufacturer's instructions for use.
NOTE 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.
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ISO 8637:2004(E)
4.2 Sterility
The blood pathway of the device shall be sterile. Compliance shall be verified in accordance with 5.3.
4.3 Nonpyrogenicity
The blood pathway of the device shall be nonpyrogenic. Compliance shall be verified in accordance with 5.4.
4.4 Mechanical characteristics
4.4.1 Structural integrity
When tested in accordance with 5.5.1, haemodialysers, haemodiafilters, haemofilters and haemo-
concentrators shall not leak. The device shall be evaluated at
a) 1,5 times the maximum pressure specified, and
b) 1,5 times the recommended sub-atmospheric pressure specified by the manufacturer, not to exceed
700 mmHg or the maximum obtainable sub-atmospheric pressure.
NOTE This requirement refers to the external case integrity of the device.
4.4.2 Blood compartment integrity
When exposing the blood compartment to a validated test procedure performed at 1,5 times the manufacturer's
maximum recommended transmembrane pressure, the blood compartment shall not leak. Compliance with this
requirement shall be verified in accordance with 5.5.2.
4.4.3 Haemodialyser, haemodiafilter and haemofilter blood compartment ports
Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood circuit are
designed as an integral system, the dimensions of the blood ports shall be as given in Figure 1. Compliance
with this requirement shall be verified in accordance with 5.5.3.
4.4.4 Haemodialyser and haemodiafilter dialysate compartment ports
The dimensions of the dialysate compartment ports shall be as given in Figure 2. Compliance with this
requirement shall be verified according to 5.5.4.
4.4.5 Haemofilter filtrate ports
The filtrate ports of haemofilters shall either comply with Figure 2 or comply with the requirements of the Luer
taper lock fitting of ISO 594-2. Compliance with this requirement shall be verified in accordance with 5.5.5.
4.4.6 Haemoconcentrator blood and filtrate ports
The blood and filtrate ports of haemoconcentrators shall allow for a secure connection to the tubing which is to
be used with the device. Compliance with this requirement shall be verified in accordance with 5.5.6.
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ISO 8637:2004(E)
Dimensions in millimetres
a
Double thread.
Figure 1 — Main fitting dimensions of blood inlet and outlet connections
4.5 Performance characteristics
4.5.1 Clearance of haemodialysers and haemodiafilters
The clearance of urea, creatinine, phosphate and vitamin B shall be determined in accordance with 5.6.1.
12
Blood and dialysate flowrates shall cover the manufacturer's recommended range.
NOTE As a supplement, K A results can be included.
0
4.5.2 Sieving coefficient of haemodiafilters, haemofilters and haemoconcentrators
The sieving coefficient for albumin, inulin and myoglobin shall be determined in accordance with 5.6.2. Test
conditions shall be as presented by the manufacturer in the labelling.
4.5.3 Filtration rate
The ultrafiltration rate shall be determined in accordance with 5.6.3. Testing shall be conducted over the
manufacturer's specified range of transmembrane pressures and blood flowrates.
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ISO 8637:2004(E)
Dimensions in millimetres
Figure 2 — Main fitting dimensions of dialysate inlet and outlet port
4.5.4 Volume of the blood compartment
The volume of the blood compartment shall be determined in accordance with 5.6.4 over the specified range of
transmembrane pressures.
If the blood compartment is noncompliant, it is acceptable to determine the volume at one transmembrane
pressure.
4.5.5 Pressure drop
4.5.5.1 Pressure drop of the blood compartment
The pressure drop of the blood compartment shall be determined in accordance with 5.6.5.1.
4.5.5.2 Pressure drop of the dialysate compartment
The pressure drop of the dialysate compartment shall be determined in accordance with 5.6.5.2.
4.6 Expiration date
Biological safety, sterility and mechanical integrity of the device shall be proven after storage for a period
corresponding to the expiration date. Compliance shall be in accordance with 5.7.
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ISO 8637:2004(E)
5 Test methods
5.1 General
The performance characteristics specified in 4.5 shall be determined prior to marketing a new type of device
and shall be re-evaluated after changes in the device that may alter its performance. If labelled for multiple uses,
devices shall be tested for clearances and ultrafiltration rate after reprocessing according to the manufacturer's
instructions, in order to characterize the effects of the recommended cleaning agent and germicide on
membrane performance.
Sample devices for testing shall be drawn at random from the manufacturer's production and shall have passed
all applicable quality control steps, as well as sterilization if applicable. They shall be prepared
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