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CEN

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)

General Information

Status
Not Published
Publication Date
05-Oct-2025
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
CEN/TC 206 - Biocompatibility of medical and dental materials and devices
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
07-Mar-2024
Completion Date
07-Mar-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN ISO 10993-4:2017/oprA1:2024 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)

Relations

Amends
EN ISO 10993-4:2017 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Effective Date
26-Apr-2023

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EN ISO 10993-4:2017/oprA1:2024EN ISO 10993-4:2017/oprA1:2024
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EN ISO 10993-4:2017/oprA1:2024
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SLOVENSKI STANDARD
SIST EN ISO 10993-4:2017/oprA1:2024
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
SIST EN ISO 10993-4:2017/oprA1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-4:2017/oprA1:2024

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SIST EN ISO 10993-4:2017/oprA1:2024
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO 10993-4:2017/DAM 1:2024(en)
© ISO 2024

---------------------- Page: 3 ----------------------
SIST EN ISO 10993-4:2017/oprA1:2024
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.
COPYRIGHT PROTECTED DOCUMENT
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
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 10993-4:2017/DAM 1:2024(en)
© ISO 2024
© ISO 2024 – All rights reserved
ii

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SIST EN ISO 10993-4:2017/oprA1:2024
ISO 10993-4:2017/DAM 1:2024(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 I
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