EN ISO 10993-10:2023
(Main)Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Hautsensibilisierung (ISO 10993-10:2021)
Dieses Dokument legt das Verfahren für die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Hautsensibilisierung auszulösen, fest.
Dieses Dokument enthält:
Einzelheiten zur Durchführung von In-vivo-Hautsensibilisierungsprüfungen;
Schlüsselfaktoren für die Interpretation der Ergebnisse.
ANMERKUNG Anhang A enthält Anweisungen für die spezielle Vorbereitung von Materialien im Zusammenhang mit den vorstehend angeführten Prüfungen.
Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation cutanée (ISO 10993-10:2021)
Le présent document spécifie le mode opératoire pour l'évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une sensibilisation cutanée.
Le présent document comprend:
— des informations détaillées relatives aux modes opératoires d'essai de sensibilisation cutanée in vivo;
— les facteurs clés pour l'interprétation des résultats.
NOTE Des instructions pour la préparation des matériaux spécifiquement pour les essais ci-dessus sont données dans l'Annexe A.
Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi preobčutljivosti kože (ISO 10993-10:2021)
Ta dokument določa postopek za presojo medicinskih pripomočkov in njihovih sestavnih materialov glede potenciala za povzročitev preobčutljivosti kože.
Dokument vsebuje:
– podrobnosti preskusnih postopkov za preobčutljivost kože;
– ključne dejavnike za razlago rezultatov.
OPOMBA Navodila za pripravo materialov posebej za zgoraj navedene preskuse so podana v dodatku A.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Nadomešča:
SIST EN ISO 10993-10:2013
Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi
preobčutljivosti kože (ISO 10993-10:2021)
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993
-10:2021)
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf
Hautsensibilisierung (ISO 10993-10:2021)
Évaluation biologique des dispositifs médicaux - Partie 10: Essais de sensibilisation
cutanée (ISO 10993-10:2021)
Ta slovenski standard je istoveten z: EN ISO 10993-10:2023
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 10993-10
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2023
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-10:2010
English Version
Biological evaluation of medical devices - Part 10: Tests for
skin sensitization (ISO 10993-10:2021)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
10: Essais de sensibilisation cutanée (ISO 10993- 10: Prüfungen auf Hautsensibilisierung (ISO 10993-
10:2021) 10:2021)
This European Standard was approved by CEN on 13 September 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 10993-10:2023) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2023, and conflicting national standards shall
be withdrawn at the latest by August 2023.
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 supersedes EN ISO 10993-10:2010.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), 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 10993-10:2021 has been approved by CEN as EN ISO 10993-10:2023 without any
modification.
Annex ZA
(informative)
Relationship between this European standard and 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 standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this 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 standard
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)/sub-clause(s) Remarks/Notes
Performance Requirements of of this EN
Regulation (EU) 2017/745
10.1 [(a) and (b)] 4, 5, 6 and 7 ER 10.1 [(a) and (b)] are only
partly covered by this document,
since the standard does not
provide requirements on design
and manufacture and packaging.
However, this standard provides
a means to assess skin
sensitization to substances used
in the manufacture of medical
devices. Other forms of toxicity
and flammability are not
covered.
10.2 4, 5, 6 and 7 ER 10.2 is only partly covered by
this document, since the
standard does not provide
requirements on design and
manufacture. However, this
standard provides a means to
assess skin sensitization to
substances leaking from medical
devices
10.4.1 (First paragraph) 4, 5, 6 and 7 ER 10.4.1 (first paragraph) is
only partly covered by this
document, since the standard
does not provide requirements
on design and manufacture.
However, this standard provides
a means to assess skin
sensitization to substances used
in the manufacture of medical
devices. Other forms of toxicity
are not covered.
NOTE This part of EN ISO 10993 refers to ISO 10993-1 which itself refers to ISO 14971. In Europe, it should
be assumed that the reference to ISO 14971 is to EN ISO 14971:2020.
General Note: Presumption of conformity depends on also complying with the relevant parts of the
ISO 10993 series.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
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 EN ISO 10993-1:2020
medical devices — Part 1:
Evaluation and testing within
a risk management process
ISO 10993-2 ISO 10993-2:2006 Biological evaluation of EN ISO 10993-2:2006
medical devices — Part 2:
Animal welfare requirements
ISO 10993-12 ISO 10993-12:2021 Biological evaluation of EN SO 10993-12:2021
medical devices - Part 12:
Sample preparation and
reference materials
ISO 10993-18 ISO 10993-18:2020 Biological evaluation of EN ISO 10993-18:2020
medical devices - Part 18:
Chemical characterization of
medical device materials
within a risk management
process
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 ISO
STANDARD 10993-10
Fourth edition
2021-11
Biological evaluation of medical
devices —
Part 10:
Tests for skin sensitization
Évaluation biologique des dispositifs médicaux —
Partie 10: Essais de sensibilisation cutanée
Reference number
ISO 10993-10:2021(E)
ISO 10993-10:2021(E)
© ISO 2021
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 10993-10:2021(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principles — Step-wise approach . 3
5 Pretest consid
...
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