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EN ISO 10993-23:2021

(Main)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
—     pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
—     details of in vitro and in vivo irritation test procedures;
—     key factors for the interpretation of the results.

Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation (ISO 10993-23:2021)

Dieses Dokument legt das Verfahren für die Bewertung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation hervorzurufen, fest. Die Prüfungen wurden so entwickelt, dass das Irritationspotential von Medizinprodukten, ihren Werkstoffen oder Extrakten nach ISO 10993 1 und ISO 10993 2 vorhergesagt und klassifiziert werden kann.
Dieses Dokument beinhaltet:
—   vor der Prüfung durchzuführende Überlegungen hinsichtlich einer Irritation, einschließlich In silico  und In vitro-Verfahren zur dermalen Exposition;
—   Einzelheiten zur Durchführung von In vitro  und In vivo-Irritationsprüfungen;
—   Schlüsselfaktoren für die Interpretation der Ergebnisse.

Évaluation biologique des dispositifs médicaux - Partie 23: Essais d'irritation (ISO 10993-23:2021, Version corrigée inclus 2021-02)

Le présent document spécifie le mode opératoire pour l'évaluation du potentiel des dispositifs médicaux et de leurs matériaux constitutifs à provoquer une irritation. Les essais sont conçus pour prédire et classer le potentiel d'irritation des dispositifs médicaux, des matériaux ou de leurs extraits conformément à l'ISO 10993‑1 et à l'ISO 10993‑2.
Le présent document comprend :
—          les considérations préalables à la réalisation des essais d'irritation, y compris des méthodes in silico et in vitro d'exposition cutanée ;
—          les informations détaillées relatives aux modes opératoires d'essai d'irritation in vitro et in vivo ;
—          les facteurs clés pour l'interprétation des résultats.

Biološko ovrednotenje medicinskih pripomočkov - 23. del: Preskusi draženja (ISO 10993-23:2021)

General Information

Status
Published
Publication Date
30-Mar-2021
Withdrawal Date
29-Sep-2021
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
31-Mar-2021
Completion Date
31-Mar-2021
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
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 10993-23:2021 - Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

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SLOVENSKI STANDARD
SIST EN ISO 10993-23:2021
01-julij-2021
Biološko ovrednotenje medicinskih pripomočkov - 23. del: Preskusi draženja (ISO
10993-23:2021)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-
23:2021)
Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation (ISO
10993-23:2021)
Évaluation biologique des dispositifs médicaux - Partie 23: Essais d'irritation (ISO 10993-
23:2021)
Ta slovenski standard je istoveten z: EN ISO 10993-23:2021
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
SIST EN ISO 10993-23:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-23:2021

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SIST EN ISO 10993-23:2021


EN ISO 10993-23
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2021
EUROPÄISCHE NORM
ICS 11.100.20
English Version

Biological evaluation of medical devices - Part 23: Tests for
irritation (ISO 10993-23:2021)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil
23: Essais d'irritation (ISO 10993-23:2021, Version 23: Prüfungen auf Irritation (ISO 10993-23:2021)
corrigée inclus 2021-02)
This European Standard was approved by CEN on 1 October 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-23:2021 E
worldwide for CEN national Members.

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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7
Annex ZC (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 9

2

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SIST EN ISO 10993-23:2021
EN ISO 10993-23:2021 (E)
European foreword
This document (EN ISO 10993-23:2021) has been prepared by Technical Committee ISO/TC 194
"Biological and clinical evaluation of medical devices" in collaboration with Technical Committee
CEN/TC 206 “Biological and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
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 September 2021, and conflicting national standards
shall be withdrawn at the latest by September 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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 Directive(s).
For the relationship with EU Directiv
...

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