ISO 8637-3:2018
(Main)Extracorporeal systems for blood purification — Part 3: Plasmafilters
Extracorporeal systems for blood purification — Part 3: Plasmafilters
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included. It specifies requirements for sterile, single-use plasmafilters, intended for use on humans. This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993. It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
Systèmes extracorporels pour la purification du sang — Partie 3: Filtres pour plasma
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 8637-3
First edition
2018-07
Extracorporeal systems for blood
purification —
Part 3:
Plasmafilters
Systèmes extracorporels pour la purification du sang —
Partie 3: Filtres pour plasma
Reference number
ISO 8637-3:2018(E)
©
ISO 2018
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ISO 8637-3:2018(E)
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© ISO 2018
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ii © ISO 2018 – All rights reserved
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ISO 8637-3:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Biological safety . 2
4.2 Sterility . 3
4.3 Non-pyrogenicity . 3
4.4 Mechanical characteristics. 3
4.4.1 Structural integrity . 3
4.4.2 Blood compartment integrity . 3
4.4.3 Connectors and ports . 3
4.4.4 Volume of the blood compartment . 5
4.4.5 Pressure drop of the blood compartment . 5
4.5 Performance characteristics. 5
4.5.1 Filtration rate . 5
4.5.2 Sieving coefficient . 5
4.5.3 Haemolytic characteristics . 6
4.6 Expiry date. 6
5 Test methods . 6
5.1 General . 6
5.2 Biological safety . 6
5.3 Sterility . 6
5.4 Non-pyrogenicity . 6
5.5 Mechanical characteristics. 7
5.5.1 Structural integrity . 7
5.5.2 Blood compartment integrity . 7
5.5.3 Blood compartment ports . 7
5.5.4 Blood compartment volume . 7
5.6 Plasma filtrate port. 7
5.7 Pressure drop . 7
5.7.1 Test solution. 7
5.7.2 Pressure drop test procedure . 7
5.8 Performance characteristics. 8
5.8.1 Filtration rate . 8
5.8.2 Sieving coefficient . 8
5.8.3 Haemolytic characteristics .10
5.9 Expiry date.10
6 Labelling .10
6.1 Labelling on the device .10
6.2 Labelling on unit containers .11
6.3 Labelling on the outer containers.11
6.4 Information to be given in the accompanying documentation .12
Bibliography .14
© ISO 2018 – All rights reserved iii
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ISO 8637-3:2018(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.
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 documents 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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following
URL: 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 first edition of ISO 8637-3:2018 cancels and replaces the second edition of ISO 13960:2010, which
has been technically revised. The following changes have been made:
— the Figures relating to connector dimensions have been revised.
A list of all the parts in the ISO 8637 series can be found on the ISO website.
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ISO 8637-3:2018(E)
Introduction
It was not found practicable to specify materials of construction. Therefore, this document only requires
that materials used have been tested, and that the testing methods and the 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.
If the plasmafilter is used with an extracorporeal circuit, 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 ISO 8637-2. The design and dimensions have been selected to minimize the risk of leakage
of blood and the ingress of air.
This document reflects the consensus of physicians, manufacturers and other interested parties for
devices that are approved for clinical use.
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INTERNATIONAL STANDARD ISO 8637-3:2018(E)
Extracorporeal systems for blood purification —
Part 3:
Plasmafilters
1 Scope
This document specifies requirements and acceptance criteria (including test methods) for safety
related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have
been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of
ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access
devices, oxygenators or active medical devices. This document does not address the replacement fluid.
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 8637-1, Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing 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 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
blood compartment
part of plasmafilter through which blood is intended to pass
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ISO 8637-3:2018(E)
3.2
filtrate compartment
part of plasmafilter through which filtrate flows
3.3
filtration rate
rate at which fluid is removed from the blood compartment (3.1) across the semipermeable membrane
into the filtrate compartment (3.2) of a plasmafilter
3.4
plasmapheresis
plasma separation
separation of a portion of the whole plasma from formed elements of blood by means of a semipermeable
membrane
Note 1 to entry: Plasmapheresis can also be accomplished through the use of differential centrifugation but this
method is not covered by this document.
3.5
plasmafilter
device intended to perform membrane plasmapheresis (3.4)
3.6
sieving coefficient
ratio of a solute concentration in the filtrate to the simultaneous concentration of the same solute in blood
3.7
transmembrane pressure
TMP
p
TM
mean pressure exerted across the semipermeable membrane
Note 1 to entry: The transmembrane pressure is given by Formula (1):
pp+
BI BO
p = − p (1)
TM F
2
where
p is the pressure at blood compartment inlet;
BI
p is the pressure at blood compartment outlet;
BO
p is the pressure at filtrate compartment outlet.
F
4 Requirements
4.1 Biological safety
Parts of the device that will come into direct or indirect contact with blood during their intended
clinical use shall be biocompatible with respect to their intended clinical use.
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.
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.
Conformity shall be verified in accordance with 5.2.
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ISO 8637-3:2018(E)
4.2 Sterility
The blood and filtrate pathways of the device shall be sterile. Conformity shall be verified in accordance
with 5.3.
4.3 Non-pyrogenicity
The blood and filtrate pathways of the device shall be non-pyrogenic. Conformity 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, plasmafilters shall not leak.
NOTE This requirement refers to the external integrity of the device.
4.4.2 Blood compartment integrity
When tested in accordance with 5.5.2, the blood compartment shall not leak.
4.4.3 Connectors and ports
4.4.3.1 Blood Compartment Ports
Except where the plasmafilter and the extracorporeal blood circuit are designed as an integral system,
the dimensions of the blood ports shall be as given in Figure 1. Conformity to this requirement shall be
verified in accordance with 5.5.3.
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ISO 8637-3:2018(E)
Key
Symbol Designation Dimension in mm Comments
α Angle of thread 15° —
β Angle of thread 15° —
γ Dimension taper rate 6:100 —
E Length of thread 10 or more —
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ISO 8637-3:2018(E)
Symbol Designation Dimension in mm Comments
F Length of tapered region 9 or more —
a
The superscript “a” of G means
a
G Thread pitch 8
double thread.
H Root diameter 13 or more —
11 Altered upper tolerance to
J Crest diameter +0,3 accommodate different components
-0,2 and materials.
Revised dimension and tolerances
1,1
K Thread crest width based on existing manufacturing
±0,25
practice.
This dimension to be measured as
cone diameter male 6
P a projection on the front face. See
plane of reference"A square" ±0,03
Figure 1 (C).
Figure 1 — Main fitting dimensions of blood inlet and outlet ports
4.4.3.2 Connection to the plasma filtrate compartment
The filtrate ports of plasmafilters shall allow for a secure connection to the tubing which is to be
used with the device, except when plasmafilters and their extracorporeal circuits are designed as an
integral system.
The dimensions of the filtrate ports shall be a male 6 % (Luer) taper lock fitting in accordance with
ISO 80369-7 or dialysis fluid inlet and o
...
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