EN ISO 10993-10:2010
(Main)Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und Hautsensibilisierung (ISO 10993-10:2010)
Dieser Teil der ISO 10993 beschreibt das Verfahren für die Beurteilung von Medizinprodukten und ihren
Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Hautsensibilisierung hervorzurufen.
Dieser Teil der ISO 10993 enthält:
a) vor der Prüfung durchzuführende Überlegungen hinsichtlich einer Irritation, einschließlich In-silico- und Invitro-
Verfahren zur dermalen Exposition;
b) Einzelheiten zur Durchführung von In-vivo-Prüfungen (Irritation und Sensibilisierung);
c) Schlüsselfaktoren für die Interpretation der Ergebnisse.
Anhang A enthält Anweisungen für die spezielle Vorbereitung von Materialien im Zusammenhang mit den
vorstehend angeführten Prüfungen. In Anhang B sind mehrere spezielle Prüfungen auf Irritation bei der
Anwendung von Medizinprodukten in anderen Bereichen als der Haut beschrieben.
Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de sensibilisation cutanée (ISO 10993-10:2010)
L'ISO 10993-10:2010 décrit le mode opératoire pour l'évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une irritation et une sensibilisation de la peau.
L'ISO 10993-10:2010 comprend
des considérations préalablement aux essais relatives à l'irritation, y compris des méthodes in silico et in vitro d'exposition dermique,
des informations détaillées relatives aux procédures d'essai in vivo (irritation et sensibilisation), et
des facteurs clés pour l'interprétation des résultats.
Des instructions sont fournies en vue de la préparation des matériaux, notamment pour les essais précités et plusieurs essais d'irritation spéciaux pour l'application de dispositifs médicaux dans des zones autres que la peau.
Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi draženja in preobčutljivosti kože (ISO 10993-10:2010)
Ta del ISO 10993 opisuje postopek za ocenjevanje medicinskih pripomočkov in materialov, iz katerih so narejeni, z vidika njihovega potenciala za povzročanje draženja in preobčutljivosti kože. Ta del ISO 10993 vključuje: a) obravnavo pred preskusom glede draženja, vključno z metodami izpostavljenost kože in silico ter in vitro; b) podrobnosti preskusnih postopkov in vivo (za draženje in preobčutljivost), in; c) ključne dejavnike pri razlagi rezultatov. Navodila za pripravo materialov, predvsem glede zgoraj navedenih preskusov, so navedena v Dodatku A. V Dodatku B je opisanih več posebnih preskusov draženja, kadar medicinski pripomočki uporabljajo drugje kot na koži.
General Information
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Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2010
1DGRPHãþD
SIST EN ISO 10993-10:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO 3UHVNXVLGUDåHQMDLQ
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization (ISO 10993-10:2010)
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und
Hautsensibilisierung (ISO 10993-10:2010)
Évaluation biologique des dispositifs médicaux - Partie 10: Essais d'irritation et de
sensibilisation cutanée (ISO 10993-10:2010)
Ta slovenski standard je istoveten z: EN ISO 10993-10:2010
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10993-10
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2010
ICS 11.100.20 Supersedes EN ISO 10993-10:2009
English Version
Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization (ISO 10993-10:2010)
Évaluation biologique des dispositifs médicaux - Partie 10: Biologische Beurteilung von Medizinprodukten - Teil 10:
Essais d'irritation et de sensibilisation cutanée (ISO 10993- Prüfung auf Irritation und Hautsensibilisierung (ISO 10993-
10:2010) 10:2010)
This European Standard was approved by CEN on 23 July 2010.
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 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2010: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5
Foreword
This document (EN ISO 10993-10:2010) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration Technical Committee CEN/TC 206 “Biological evaluation of
medical devices” the secretariat of which is held by NEN.
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 February 2011, and conflicting national standards shall be withdrawn
at the latest by February 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10993-10:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this
document.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10993-10:2010 has been approved by CEN as a EN ISO 10993-10:2010 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
International Standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 93/42/EEC
4, 5, 6, 7, 8, Annexes A, B and C 7.1, 7.2, 7.5 Within the limits of the Scope of this
standard.
6.5 and Annex C 6a Subclause 6.5 and Annex C contain
requirements that are relevant to clinical
investigations according to section 2 of
Annex X, as referred to in essential
requirement 6a of Directive 93/42/EEC.
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 90/385/EEC on Active Implantable Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active Implantable Medical Devices.
Once this Standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
International Standard given in Table ZB.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on Active
Implantable Medical Devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
European Standard of Directive 90/385/EEC
4, 5, 6, 7, 8, Annexes A, B and C 9 (first and second indents only) Within the limits of the Scope of
this standard.
6.5 and Annex C 5a Subclause 6.5 and Annex C
contain requirements that are
relevant to clinical investigations
according to section 2 of Annex
7, as referred to in essential
requirement 5a of Directive
90/385/EEC.
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 10993-10
Third edition
2010-08-01
Biological evaluation of medical
devices —
Part 10:
Tests for irritation and skin sensitization
Évaluation biologique des dispositifs médicaux —
Partie 10: Essais d'irritation et de sensibilisation cutanée
Reference number
ISO 10993-10:2010(E)
©
ISO 2010
ISO 10993-10:2010(E)
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ISO 10993-10:2010(E)
Contents Page
Foreword .iv
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General principles — Step-wise approach .4
5 Pretest considerations.4
5.1 General .4
5.2 Types of material .5
5.3 Information on chemical composition .5
6 Irritation tests.6
6.1 In vitro irritation tests.6
6.2 In vivo irritation tests — Factors to be considered in design and selection of in vivo tests .6
6.3 Animal irritation test.7
6.4 Animal intracutaneous (intradermal) reactivity test .11
6.5 Human skin irritation test .14
7 Skin sensitization tests.15
7.1 Choice of test methods.15
7.2 Murine Local Lymph Node Assay (LLNA).15
7.3 Guinea pig assays for the detection of skin sensitization.18
7.4 Important factors affecting the outcome of the test .19
7.5 Guinea pig maximization test (GPMT).20
7.6 Closed-patch test (Buehler test) .23
8 Key factors in interpretation of test results.26
Annex A (normative) Preparation of materials for irritation/sensitization testing.
...
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