SIST EN ISO 10993-4:2017/A1:2025

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025)

Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut - Änderung 1 (ISO 10993-4:2017/Amd 1:2025)

Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les interactions avec le sang - Amendement 1 (ISO 10993-4:2017/Amd 1:2025)

Biološko ovrednotenje medicinskih pripomočkov - 4. del: Izbira preskusov za ugotavljanje interakcij s krvjo - Dopolnilo A1 (ISO 10993-4:2017/Amd 1:2025)

General Information

• Status: Published
• Public Enquiry End Date: 29-May-2024
• Publication Date: 09-Mar-2025
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Mar-2025
• Due Date: 11-May-2025
• Completion Date: 10-Mar-2025
• 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: EN ISO 10993-4:2017/A1:2025 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025)

Relations

• Amends: SIST 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: 01-Apr-2025

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2025
Biološko ovrednotenje medicinskih pripomočkov - 4. del: Izbira preskusov za
ugotavljanje interakcij s krvjo - Dopolnilo A1 (ISO 10993-4:2017/Amd 1:2025)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut - Änderung 1 (ISO 10993-4:2017/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie 4: Choix des essais pour les
interactions avec le sang - Amendement 1 (ISO 10993-4:2017/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 10993-4:2017/A1:2025
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.

EN ISO 10993-4:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2025
EUROPÄISCHE NORM
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 4: Selection
of tests for interactions with blood - Amendment 1 (ISO
10993-4:2017/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 4:
4: Choix des essais pour les interactions avec le sang - Auswahl von Prüfungen zur Wechselwirkung mit Blut -
Amendement 1 (ISO 10993-4:2017/Amd 1:2025) Änderung 1 (ISO 10993-4:2017/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 10993-4:2017; it was approved by CEN on 1 July 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-4:2017/A1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4

European foreword
This document (EN ISO 10993-4:2017/A1:2025) has been prepared by Technical Committee ISO/TC
194 "Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
This Amendment to the European Standard EN ISO 10993-4:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by August 2025, and
conflicting national standards shall be withdrawn at the latest by August 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10993-4:2017/Amd 1:2025 has been approved by CEN as EN ISO 10993-
4:2017/A1:2025 without any modification.

Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this harmonised standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex Z. For the purpose of using
this standard in support of the requirements set out in Regulation (EU) 2017/745, the definitions set
out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this document
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices ((EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I
of Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and Clause(s)/subclause(s) of Remarks/Notes
Performance Requirements this EN
of Regulation
(EU) 2017/745
10.1 [(a) and (b)] 6 GSPR 10.1 [(a) and (b)] is partly
covered by this document since the
document does not provide
requirements on design and
manufacture and packaging.
However, this document provides a
means to assess interactions of
medical devices/materials with
blood.
Other forms of toxicity and
flammability are not covered.
10.2 6 GSPR 10.2 is partly covered by this
document since the document does
not provide requirements on
design and manufacture. However,
this document provides a means to
assess interactions of
contaminants and residues from
medical devices/materials with
blood.
10.4.1 (first paragraph) 6 GSPR 10.4.1 (first paragraph) is
partly covered by this document
since the document does not
provide requirements on design
and manufacture. However, this
document provides a means to
assess interactions of medical
devices/materials with blood.
Other forms of toxicity are not
covered.
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of medical EN ISO 10993-1:2020
devices - Part 1: Evaluation and
testing within a risk management
process
ISO 10993-12 ISO 10993- Biological evaluation of medical EN ISO 10993-12:2021
12:2021 devices — Part 12: Sample
preparation and reference
materials
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e., are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
International
Standard
ISO 10993-4
Third edition
Biological evaluation of medical
2017-04
devices —
AMENDMENT 1
Part 4:
2025-01
Selection of tests for interactions
with blood
AMENDMENT 1
Évaluation biologique des dispositifs médicaux —
Partie 4: Choix des essais pour les interactions avec le sang
AMENDEMENT 1
Reference number
ISO 10993-4:2017/Amd.1:2025(en) © ISO 2025

ISO 10993-4:2017/Amd.1:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 10993-4:2017/Amd.1:2025(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 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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