EN ISO 10993-10:2013

SLOVENSKI STANDARD
01-november-2013
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SIST EN ISO 10993-10:2010
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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 10993-10:2013
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 2013
ICS 11.100.20 Supersedes EN ISO 10993-10:2010
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:
Essais d'irritation et de sensibilisation cutanée (ISO 10993-
10:2010)
This European Standard was approved by CEN on 9 July 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2013: 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
The text of ISO 10993-10:2010 has been prepared by Technical Committee ISO/TC 194 "Biological evaluation
of medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 10993-10:2013 by 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 2014, and conflicting national standards shall be withdrawn
at the latest by February 2014.
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 10993-10:2010.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10993-10:2010 has been approved by CEN as EN ISO 10993-10:2013 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 Qualifying remarks/Notes
European Standard (ERs) of Directive 93/42/EEC
ER 7.1 is only partly covered by EN ISO
4, 5, 6, 7, 8, Annexes A, B and C 7.1 first and second indents
10993-10, since the standard does not
only
provide requirements on design and
manufacture. However, this standard
provides a means to assess irritancy
and skin sensitization to substances used
in the manufacture of medical devices.
Other forms of toxicity and flammability
are not covered.
ER 7.2 is only partly covered by EN ISO
4, 5, 6, 7, 8, Annexes A, B and C 7.2
10993-10, since the standard does not
provide requirements on design,
manufacture and packaging. However,
this standard provides a means to assess
irritancy and skin sensitization to
contaminants and residues in medical
devices.
ER 7.5 is only partly covered by EN ISO
4, 5, 6, 7, 8, Annexes A, B and C 7.5 first sentence of the first
10993-10, since the standard does not
paragraph only.
provide requirements on design and
manufacture. However, this standard
provides a means to assess irritancy
and skin sensitization to substances
leaking from medical devices
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
EN 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 ER 9 is only partly covered by
EN ISO 10993-10, since the
standard does not provide
requirements on design and
manufacture. However, this
standard provides a means to
assess irritancy and skin
sensitization to substances used
in the manufacture of medical
devices. Other forms of toxicity
are not covered.
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 M
...