EN ISO 10993-4:2017/prA1
(Amendment)Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut - Änderung 1 (ISO 10993 4:2017/DAM 1:2024)
Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les interactions avec le sang - Amendement 1 (ISO 10993-4:2017/DAmd 1:2024)
Biološko ovrednotenje medicinskih pripomočkov - 4. del: Izbira preskusov za ugotavljanje interakcij s krvjo - Dopolnilo A1 (ISO 10993 4:2017/DAmd 1:2024)
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SLOVENSKI STANDARD
01-maj-2024
Biološko ovrednotenje medicinskih pripomočkov - 4. del: Izbira preskusov za
ugotavljanje interakcij s krvjo - Dopolnilo A1 (ISO 10993 4:2017/DAmd 1:2024)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut - Änderung 1 (ISO 10993 4:2017/DAM 1:2024)
Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les
interactions avec le sang - Amendement 1 (ISO 10993-4:2017/DAmd 1:2024)
Ta slovenski standard je istoveten z: EN ISO 10993-4:2017/prA1
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
Amendment
ISO 10993-4:2017/
DAM 1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 4:
2024-03-07
Selection of tests for interactions
Voting terminates on:
with blood 2024-05-30
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 4: Choix des essais pour les interactions avec le sang
AMENDEMENT 1
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 10993-4:2017/DAM 1:2024(en)
DRAFT
ISO 10993-4:2017/DAM 1:2024(en)
Amendment
ISO 10993-4:2017/
DAM 1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 4:
Selection of tests for interactions
Voting terminates on:
with blood
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 4: Choix des essais pour les interactions avec le sang
AMENDEMENT 1
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
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Published in Switzerland Reference number
ISO 10993-4:2017/DAM 1:2024(en)
ii
ISO 10993-4:2017/DAM 1:2024(en)
Foreword
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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of
medical devices.
This amendment to ISO 10993-4:2017 refines certain language, clarifies examples of devices with indirect
blood contact and direct blood contact, and adds additional current references.
A list of all parts in the ISO 10993 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.
iii
ISO 10993-4:2017/DAM 1:2024(en)
Biological evaluation of medical devices —
Part 4:
Selection of tests for interactions with blood
AMENDMENT 1
5.2.2
Replace the heading with the following:
5.2.2 External communicating devices that have indirect blood contact
Delete the following bullet points “cannulae”, “cell savers” and “intravascular catheters”.
Replace “blood and blood product” with “saline and/or therapeutics” to read:
— devices for the storage and administration of saline and/or therapeutics (e.g. tubing and bags);
Add the bullet point “- blood monitors with indirect blood contact.” at the end of the list.
5.2.3
Add “blood collection devices” as a second bullet point, “cannulae” as a fourth bullet point, “cell savers” as a
sixth bullet point and “devices for the storage and administration of blood and blood products (e.g. tubing
and bags)” as a eighth bullet point.
Delete “or indirect” in the third bullet point to read:
— blood monitoring devices with direct blood contact;
6.1.2
Add to the second paragraph after the sentence “Only direct or indirect blood-contacting parts should be
tested.” the following sentences:
For direct contact haemocompatibility testing (e.g., direct haemolysis, complement activation,
coagulation, platelet activation, haematology, in vitro/ex vivo thrombosis), testing should be conducted
using only the direct blood contacting components of the device to minimize interference of non-
direct blood contacting components on the results. For extract-based haemocompatibility testing (e.g.,
indirect haemolysis), testing should be conducted using only the direct and indirect blood-contacting
ISO 10993-4:2017/DAM 1:2024(en)
components of the device. The test article shall be described, and a justification shall be provided if the
test article includes device components that include different tissue contact than described above.
Remove the fourth paragraph and replace with:
As many tests for haemocompatibility are recognized to be generally surface-contact dependent (e.g.,
direct contact haemolysis, complement activation, coagulation, platelet activation, haematology, and
in vitro/ex vivo thrombosis) such tests will not apply to indirect contact applications. For externally
communicating medical devices or components that have indirect blood contact, generally only an
indirect contact hemolysis test is recommended.
6.1.4
Change NOTE 1 to read:
NOTE 1 Changes in manufacturing process e.g., change in manufacturer, use of different manufacturing
aids that could affect the surface properties, or chemistry of the complete sterilized device, could also impact
haemocompatibility.
6.1.6
Change Table 1 to read:
ISO 10993-4:2017/DAM 1:2024(en)
Table 1 — Devices or device components and categories of appropriate testing for consideration
Test category
c
Haemolysis Thrombosis
in vitro
In
Device examples
Me-
Plate-
vivo/
Materi- chani- Coag-
let Comple- Haema-
Ex
al- cally- ula-
d
activa- ment tology
a
vivo
induced in- tion
tion
duced
e
External communicating devices indirectly contacting blood
Blood monitors with indirect blood contact X
Devices for storage and administration of saline
and/or therapeutics (e.g. tubing and bags), exten- X
sion sets
b
External communicating devices directly contacting circulating blood
Blood collection devices X X X X
Blood administration sets and extension sets X X X X X
Catheters in place for less than 24 h (e.g. atherecto-
my devices,
intravascular ultrasound catheters, antegrade/ X X X X X
retrograde coronary
perfusion catheters, guide wires); cannulae
Catheters in place for more than 24 h (e.g. paren-
teral nutrition catheters, central venous cathe- X X X X X
ters); cannulae
Cell savers X X X
Devices for adsorption of specific substances from
X X X X X
blood
Donor and therapeutic aphaeresis equipment and
X X X X X
cell separation systems
Cardiopulmonary bypass system X X X X X X X
Haemodialysis/haemofiltration equipment X X X X X X X
Leukocyte removal filter X X X X X X
Percutaneous circulatory support devices X X X X X X X
Implant devices
Annuloplasty rings, mechanical heart valves X X X
Embolization devices X X
Endovascular grafts X X
Implantable defibrillator and cardioverter leads X X
a
Thrombosis is an in vivo or ex vivo phenomenon but can be simulated with in vitro conditions. In vivo or ex vivo testing might
not be necessary if clinically relevant in vitro thrombosis testing is performed.
b
Some examples here may contain other components with indirect blood contact. For device components that only have
indirect blood contact, direct contact material-induced haemolysis, mechanical haemolysis, thrombosis, and complement
activation may not be necessary. For externally communicating medical devices with indirect blood contact, generally only an
indirect contact hemolysis test is recommended.
c
It is recognized that coagulation, platelet, and leucocyte responses are primarily involved in the process of thrombosis.
Therefore, in vitro thrombogenicity methods can be acceptable in place of in vivo testing if scientifically justified. The
manufacturer should justify which specific testing in the coagulation, platelet and haematology test categories is appropriate for
their devices.
d
Complement activation testing is also requested by certain regulatory authorities to address other end points such as
anaphylaxis for all devices with direct blood contact.
e
Except for devices composed of novel materials, thrombogenicity testing is generally not necessary for indirect blood contact
devices composed of commonly used materials.
ISO 10993-4:2017/DAM 1:2024(en)
TTabablele 1 1 ((ccoonnttiinnueuedd))
Test category
c
Haemolysis Thrombosis
in vitro
In
Device examples
Me-
Plate-
vivo/
Materi- chani- Coag-
let Comple- Haema-
Ex
al- cally- ula-
d
activa- ment tology
a
vivo
induced in- tion
tion
duced
Intra-aortic balloon pumps X X X
Pacemaker leads X X
Prosthetic (synthetic) vascular grafts and patches,
including X X
arteriovenous shunts
Stents (vascular) X X
Tissue heart valves, vascular grafts and patches
X X
and AV shunts
Total artificial hearts X X X
Vena cava filters X X
Ventricular-assist devices X X X
a
Thrombosis is an in vivo or ex vivo phenomenon but can be simulated with in vitro conditions. In vivo or ex vivo testing might
not be necessary if clinically relevant in vitro thrombosis testing is performed.
b
Some examples here may contain other components with indirect blood contact. For device components that only have
indirect blood contact, direct contact material-induced haemolysis, mechanical haemolysis, thrombosis, and complement
activation may not be necessary. For externally communicating medical devices with indirect blood contact, generally only an
indirect contact hemolysis test is recommended.
c
It is recognized that coagulation, platelet, and leucocyte responses are primarily involved in the process of thrombosis.
Therefore, in vitro thrombogenicity methods can be acceptable in place of in vivo testing if scientifically justified. The
manufacturer should justify which specific testing in the coagulation, platelet and haematolo
...
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