EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.
ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Biologische Beurteilung von Medizinprodukten - Teil 3: Prüfungen auf Gentoxizität, Karzinogenität und Reproduktionstoxizität (ISO 10993-3:2014)

Dieser Teil der ISO 10993 legt spezifische Strategien für die Gefahrenerkennung sowie Prüfverfahren für Medizinprodukte für die nachfolgenden biologischen Aspekte fest:
 Genotoxizität,
 Karzinogenität und
 Reproduktions- und Entwicklungstoxizität.
Dieser Teil der ISO 10993 ist anwendbar, sobald die Notwendigkeit festgestellt wurde, ein Medizinprodukt auf potenzielle Genotoxizität, Karzinogenität oder Reproduktionstoxizität zu untersuchen.
ANMERKUNG Anleitung zur Auswahl der Prüfungen ist in ISO 10993-1 enthalten.

Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO 10993-3:2014)

L'ISO 10993-3:2014 spécifie les stratégies pour l'estimation des risques, le choix des essais d'identification des risques et la gestion des risques, en fonction du risque d'apparition des effets biologiques potentiellement irréversibles suivants résultant de l'exposition à des dispositifs médicaux:
génotoxicité;
cancérogénicité;
toxicité sur la reproduction et le développement.
L'ISO 10993-3:2014 est applicable lorsque le besoin d'évaluer un dispositif médical dont le risque de génotoxicité, de cancérogénicité ou de toxicité sur la reproduction a été identifié.

Biološko ovrednotenje medicinskih pripomočkov - 3. del: Preskusi genske toksičnosti, kancerogenosti in toksičnosti za razmnoževanje (ISO 10993-3:2014)

Ta del standarda ISO 10993 določa strategije za oceno tveganja, izbiro preskusov za prepoznavanje nevarnosti
in upravljanje tveganja ob upoštevanju možnosti naslednjih potencialno nepovratnih bioloških
učinkov, ki so posledica izpostavljenosti medicinskim pripomočkom:
– genska toksičnost;
– kancerogenost;
– toksičnost za razmnoževanje in razvoj.
Ta del standarda ISO 10993 se uporablja, ko je ugotovljena potreba po ovrednotenju potencialne genske toksičnosti, kancerogenosti ali toksičnosti za razmnoževanje medicinskega pripomočka.
OPOMBA: Navodila za izbiro preskusov so zajeta v standardu ISO 10993-1.

General Information

• Status: Published
• Publication Date: 14-Oct-2014
• Withdrawal Date: 29-Apr-2015
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Oct-2014
• Completion Date: 15-Oct-2014
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10993-3:2015 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Relations

• Replaces: EN ISO 10993-3:2009 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
• Effective Date: 22-Oct-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-3:2015
01-januar-2015
1DGRPHãþD
SIST EN ISO 10993-3:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVLJHQVNH
WRNVLþQRVWLNDQFHURJHQRVWLLQWRNVLþQRVWL]DUD]PQRåHYDQMH,62
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity
and reproductive toxicity (ISO 10993-3:2014)
Biologische Beurteilung von Medizinprodukten - Teil 3: Prüfungen auf Gentoxizität,
Karzinogenität und Reproduktionstoxizität (ISO 10993-3:2014)
Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la
génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO 10993-3:2014)
Ta slovenski standard je istoveten z: EN ISO 10993-3:2014
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-3:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-3:2015

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SIST EN ISO 10993-3:2015

EUROPEAN STANDARD
EN ISO 10993-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2014
ICS 11.100.20 Supersedes EN ISO 10993-3:2009
English Version
Biological evaluation of medical devices - Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity (ISO
10993-3:2014)
Évaluation biologique des dispositifs médicaux - Partie 3: Biologische Beurteilung von Medizinprodukten - Teil 3:
Essais concernant la génotoxicité, la cancérogénicité et la Prüfungen auf Gentoxizität, Karzinogenität und
toxicité sur la reproduction (ISO 10993-3:2014) Reproduktionstoxizität (ISO 10993-3:2014)
This European Standard was approved by CEN on 6 September 2014.

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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-3:2014 E
worldwide for CEN national Members.

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SIST EN ISO 10993-3:2015
EN ISO 10993-3:2014 (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 .6

2

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SIST EN ISO 10993-3:2015
EN ISO 10993-3:2014 (E)
Foreword
This document (EN ISO 10993-3:2014) 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
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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
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 10993-3:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, an
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