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

Status
Published
Publication Date
16-Jul-2018
Current Stage
9092 - International Standard to be revised
Start Date
11-Dec-2019
Completion Date
11-Dec-2019
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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
---------------------- Page: 1 ----------------------
ISO 8637-3:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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.
iv © ISO 2018 – All rights reserved
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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.
© ISO 2018 – All rights reserved v
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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
© ISO 2018 – All rights reserved 1
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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
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
where
p is the pressure at blood compartment inlet;
p is the pressure at blood compartment outlet;
p is the pressure at filtrate compartment outlet.
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.
2 © ISO 2018 – All rights reserved
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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.
© ISO 2018 – All rights reserved 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 —
4 © ISO 2018 – All rights reserved
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ISO 8637-3:2018(E)
Symbol Designation Dimension in mm Comments
F Length of tapered region 9 or more —
The superscript “a” of G means
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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