EN 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

• Status: Withdrawn
• Publication Date: 31-Jul-2010
• Withdrawal Date: 20-Aug-2013
• 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: 21-Aug-2013
• Completion Date: 21-Aug-2013
• 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 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

Relations

• Replaces: 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)
• Effective Date: 04-Jul-2009
• Replaced By: EN ISO 10993-10:2023 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
• Effective Date: 19-Jan-2023
• Replaced By: EN ISO 10993-10:2013 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
• Effective Date: 21-Aug-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-10:2010
01-oktober-2010
1DGRPHãþD
SIST EN ISO 10993-10:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLGUDåHQMDLQ
SUHREþXWOMLYRVWLNRåH,62
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
SIST EN ISO 10993-10:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-10:2010

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SIST EN ISO 10993-10:2010


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.

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SIST EN ISO 10993-10:2010
EN ISO 10993-10:2010 (E)
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

2

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SIST EN ISO 10993-10:2010
EN ISO 10993-10:2010 (E)
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
...