EN ISO 10993-10:2013

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: Prüfungen 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)

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 standarda ISO 10993 opisuje postopek za presojo medicinskih pripomočkov in njihovih sestavnih materialov glede njihovega potenciala za povzročitev draženja in preobčutljivosti kože. Ta del standarda ISO 10993 zajema: a) premisleke glede draženja pred preskusom, vključno z metodami in silico in in vitro za izpostavljenost kože, b) podrobnosti preskusnih postopkov in vivo (draženje in preobčutljivost), c) ključne dejavnike za razlago rezultatov. V Dodatku A so podana navodila za pripravo materialov, zlasti v zvezi z zgornjimi preskusi. V Dodatku B je opisanih več posebnih preskusov draženja pri uporabi medicinskih pripomočkov na drugih delih telesa (ne na koži).

General Information

• Status: Withdrawn
• Publication Date: 20-Aug-2013
• Withdrawal Date: 07-Feb-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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 205 - Non-active medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10993-10:2013 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

Relations

• Replaces: EN ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
• Effective Date: 21-Aug-2013
• Replaced By: EN ISO 10993-10:2023 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
• Effective Date: 22-Feb-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-10:2013
01-november-2013
1DGRPHãþD
SIST EN ISO 10993-10:2010
%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 10993-10:2013
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-10:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-10:2013

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SIST EN ISO 10993-10:2013


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.

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SIST EN ISO 10993-10:2013
EN ISO 10993-10:2013 (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 10993-10:2013
EN ISO 10993-10:2013 (E)
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,
...