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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Status
Not Published
Public Enquiry End Date
29-May-2024
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
04-Apr-2024
Due Date
22-Aug-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
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This document is circulated as received from the committee secretariat.
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Reference number
ISO 10993-4:2017/DAM 1:2024(en)
© ISO 2024

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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
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BE CONSIDERED IN THE LIGHT OF THEIR
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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
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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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