EN ISO 10993-10:2009

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This part of ISO 10993 includes a) pretest considerations, b) details of the test procedures, and c) key factors for the interpretation of the results. Instructions are given in annex A for the preparation of materials specifically in relation to the above tests. Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.

Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfungen auf Irritation und Allergien vom verzögerten Typ (ISO 10993-10:2002, einschließlich Änderung 1:2006)

Dieser Teil der ISO 10993 beschreibt Verfahren für die Beurteilung von Medizinprodukten und ihren
Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Allergie vom verzögerten Typ
hervorzurufen.
Dieser Teil der ISO 10993 enthält:
a) vor der Prüfung durchzuführende Überlegungen;
b) Einzelheiten zur Durchführung der Prüfungen und
c) Schlüsselfaktoren für die Interpretation der Ergebnisse.
Anhang A enthält Anweisungen für die spezielle Vorbereitung von Materialien im Zusammenhang mit den
genannten Prüfungen.
Zusätzliche Prüfungen, die speziell für intrakutan und im Bereich der Augen, im Bereich der Mundhöhle, des
Enddarms, des Penis oder der Vagina anzuwendende Produkte erforderlich sind, gibt der Anhang B.

Evaluation biologique des dispositifs médicaux - Partie 10 : Essais d'irritation et d'hypersensibilité retardée (ISO 10993-10:2002, Amd 1:2006 inclus)

Biološko ovrednotenje medicinskih pripomočkov - 10. del: Preskusi draženja in zakasnjene preobčutljivosti (ISO 10993-10:2002, vključno z Amd 1:2006)

General Information

• Status: Withdrawn
• Publication Date: 28-Apr-2009
• Withdrawal Date: 31-Jul-2010
• ICS: 11.100 - Laboratory medicine
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Aug-2010
• Completion Date: 01-Aug-2010
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 10993-10:2009 - Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

Relations

• Replaces: EN ISO 10993-10:2002/A1:2006 - Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 (ISO 10993-10:2002/Amd 1:2006)
• Effective Date: 06-May-2009
• Replaces: EN ISO 10993-10:2002 - Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
• Effective Date: 06-May-2009
• Replaced By: EN ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
• Effective Date: 04-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 10993-10:2003
SIST EN ISO 10993-10:2003/A1:2006
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLGUDåHQMDLQ
]DNDVQMHQHSUHREþXWOMLYRVWL,62YNOMXþQR]$PG
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type
hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)
Biologische Beurteilung von Medizinprodukten - Teil 10: Prüfung auf Irritation und
Allergien vom verzögerten Typ (ISO 10993-10:2002, einschließlich Änderung 1:2006)
Evaluation biologique des dispositifs médicaux - Partie 10 : Essais d'irritation et
d'hypersensibilité retardée (ISO 10993-10:2002, Amd 1:2006 inclus)
Ta slovenski standard je istoveten z: EN ISO 10993-10:2009
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
April 2009
ICS 11.100.20 Supersedes EN ISO 10993-10:2002
English Version
Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity (ISO 10993-10:2002,
including Amd 1:2006)
Evaluation biologique des dispositifs médicaux - Partie 10 : Biologische Beurteilung von Medizinprodukten - Teil 10:
Essais d'irritation et d'hypersensibilité retardée (ISO 10993- Prüfung auf Irritation und Allergien vom verzögerten Typ
10:2002, Amd 1:2006 inclus) (ISO 10993-10:2002, einschließlich Änderung 1:2006)
This European Standard was approved by CEN on 12 April 2009.
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, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-10:2009: 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 10993-10:2002, including Amd 1:2006 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 10993-10:2009 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 10993-10:2002.
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 93/42/EEC on
Medical Devices and 90/385/EEC on Active Implantable Medical Devices.
For relationship with EU Directives, see informative Annex ZA and ZB, which is an integral part 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, 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 10993-10:2002, including Amd 1:2006 has been approved by CEN as a EN ISO 10993-
10:2009 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 Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA 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 ZA — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4, 5, 6, 7, 8 and annex A and B Annex I:
7.1, 7.2, 7.5
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 Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZB 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 — 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) of Qualifying remarks/Notes
EN Directive 90/385/EEC
4, 5, 6, 7, 8 and annex A and B
Annex I :
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
Second edition
2002-09-01
Biological evaluation of medical devices —
Part 10:
Tests for irritation and delayed-type
hypersensitivity
Évaluation biologique des dispositifs médicaux —
Partie 10: Essais d'irritation et d'hypersensibilité retardée

Reference number
ISO 10993-10:2002(E)
©
ISO 2002
ISO 10993-10:2002(E)
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ISO 10993-10:2002(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 . 3
5 Pretest considerations. 4
5.1 General . 4
5.2 Types of material. 4
5.3 Information on chemical composition . 4
5.4 Material characterization . 5
6 Irritation tests . 5
6.1 In vitro irritation tests . 5
6.2 Factors to be considered in design and selection of in vivo tests . 5
6.3 Animal skin irritation test . 6
6.4 Human skin irritation test. 10
7 Delayed hypersensitivity tests. 14
7.1 Choice of test. 14
7.2 Choice of test sample concentrations . 14
7.3 Other important factors affecting the outcome of the test . 14
7.4 Maximization test for delayed hypersensitivity . 15
7.5 Closed-patch test for delayed hypersensitivity . 18
8 Key factors in interpretation of test results. 20
Annex A (normative) Preparation of materials for irritation/sensitization testing. 21
Annex B (informative) Additional irritation tests.23
Annex C (informative) Background information. 41
Bibliography.
...