SIST EN ISO 10993-23:2021/A1:2025

SLOVENSKI STANDARD
01-oktober-2025
Biološko ovrednotenje medicinskih pripomočkov - 23. del: Preskusi draženja -
Dopolnilo A1: Dodatni in vitro modeli rekonstruirane človeške povrhnjice (ISO
10993-23:2021/Amd 1:2025)
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1:
Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd
1:2025)
Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation -
Änderung 1 (ISO 10993-23:2021/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie 23: Essais d'irritation -
Amendement 1: Modèles supplémentaires d'épiderme humain reconstruit in vitro (ISO
10993-23:2021/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 10993-23:2021/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-
EUROPEAN STANDARD
23:2021/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2025
ICS 11.100.20
English Version
Biological evaluation of medical devices - Part 23: Tests for
irritation - Amendment 1: Additional in vitro
reconstructed human epidermis models (ISO 10993-
23:2021/Amd 1:2025)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
23: Essais d'irritation - Amendement 1: Modèles 23: Prüfungen auf Irritation - Änderung 1 (ISO 10993-
supplémentaires d'épiderme humain reconstruit in 23:2021/Amd 1:2025)
vitro (ISO 10993-23:2021/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 10993-23:2021; it was approved by CEN on 19 January 2025.

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 10993-23:2021/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 10993-23:2021/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 10993-23:2021 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by February
2026, and conflicting national standards shall be withdrawn at the latest by February 2026.
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 10993-23:2021/Amd 1:2025 has been approved by CEN as EN ISO 10993-
23:2021/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.
NOTE 4 The Table ZA.1 for Relationship between this European Standard the General Safety and Performance
Requirements of Regulation (EU) 2017/745 aimed to be covered has not changed compared to the 2021 version
but the Annex itself was renamed from Annex ZC to Annex ZA. Furthermore, Table ZA.2 was added.

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
Performance Clause(s) / sub-
Requirements of clause(s) Remarks / Notes
Regulation (EU) of this EN
2017/745
10.1 is only partly covered by this document, since
the document does not provide requirements on
design and manufacture. However, this document
provides a means to assess potential irritancy
4, 5, 6, 7, 8 and induced by chemical and/or physical properties of
10.1 a), b), g) and h)
Annex A, D and E substances used in the manufacture of medical
devices.
Other forms of toxicity and flammability (10.1 a) and
b) are not covered.
10.2 is only partly covered by this document, since
the document does not provide requirements on
4, 5, 6, 7, 8 and
design, manufacture and packaging and does not
Annex A, D and E
10.2
oblige to minimize risk. However, this document

provides a means to assess irritancy to contaminants
and residues in medical devices.
10.4.1 is only partly covered by this document, since
the document does not provide requirements on
design and
10.4.1 (First paragraph, manufacture. However, this document provides a
4, 5, 6, 7, 8 and
first means to assess irritancy to substances leaking from
Annex A, D and E
medical devices. This evaluation can be a
sentence)
preliminary step for risk minimization.
Other forms of toxicity are not dealt with in this
document.
General NOTE: Presumption of conformity depends on also complying with the relevant parts of the ISO 10993
series.
Table ZA.2 — Normative references from clause 2 of this document and their corresponding
European publications
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Clause 2 Title Corresponding European
Standard Edition
ISO 10993-1 ISO 10993-1:2018 Biological evaluation of EN ISO 10993-1:2020
medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 10993-2 ISO 10993-2:2022 Biological evaluation of EN ISO 10993-2:2022
medical devices — Part 2:
Animal welfare requirements
ISO 10993-9 ISO 10993-9:2019 Biological evaluation of EN ISO 10993-9:2021
medical devices — Part 9:
Framework for identification
and quantification of potential
degradation products
ISO 10993-12 ISO 10993-12:2021 Biological evaluation of EN ISO 10993-12:2021
medical devices — Part 12:
Sample preparation and
reference materials
ISO 10993-13 ISO 10993-13:2010 Biological evaluation of EN ISO 10993-13:2010
medical devices — Part 13:
Identification and
quantification of degradation
products from polymeric
medical devices
ISO 10993-14 ISO 10993-14:2001 Biological evaluation of EN ISO 10993-14:2009
medical devices — Part 14:
Identification and
quantification of degradation
products from ceramics
ISO 10993-15 ISO 10993-15:2019 Biological evaluation of EN ISO 10993-15:2023
medical devices — Part 15:
Identification and
quantification of degradation
products from metals and
alloys
ISO 10993-18 ISO 10993-18:2020 Biological evaluation of EN ISO 10993-18:2020
ISO 10993-18:2020/Amd medical devices — Part 18: ISO 10993-18:2020/Amd
1:2022 Chemical characterization of 1:2023
medical device materials
within a risk management
process
ISO 14155 ISO 14155:2020 Clinical investigation of EN ISO 14155:2020
medical devices for human EN ISO 14155:2020/A11:2
subjects — Good clinical 024
practice
OECD 404 None Acute Dermal None
Irritation/Corrosion
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Clause 2 Title Corresponding European
Standard Edition
OECD 439 None In Vitro Skin Irritation: None
Reconstructed Human
Epidermis Test Method
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.
NOTE 5 Justification for the use of OECD 404 and OECD 439 as normative references was presented to the
European Commission and was accepted.
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 10993-23
First edition
Biological evaluation of medical
2021-01
devices —
AMENDMENT 1
Part 23:
2025-05
Tests for irritation
AMENDMEN
...