EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf In-vitro-Zytotoxizität (ISO 10993-5:2009)

Die vorliegende Internationale Norm beschreibt Prüfverfahren zur Beurteilung der In-vitro-Zytotoxizität von Medizinprodukten.
Diese Verfahren legen die Bebrütung von Kulturzellen fest, entweder in direktem Kontakt mit einem Medizin-produkt und/oder Extrakten eines Medizinprodukts oder durch Diffusion.
Diese Verfahren sind dafür ausgelegt, die biologische Reaktion von Säugetierzellen in vitro unter Anwendung geeigneter biologischer Parameter zu bestimmen.

Évaluation biologique des dispositifs médicaux - Partie 5: Essais concernant la cytotoxicité in vitro (ISO 10993-5:2009)

L'ISO 10993-5:2009 spécifie les méthodes d'essai d'évaluation de la cytotoxicité in vitro des dispositifs médicaux.
Ces méthodes décrivent l'incubation des cellules cultivées en contact avec un dispositif et/ou des extraits de dispositif, soit directement, soit par diffusion.
Elles sont conçues pour déterminer la réponse biologique in vitro des cellules de mammifère au moyen de paramètres biologiques adaptés.

Biološko ovrednotenje medicinskih pripomočkov - 5. del: Preskusi za ugotavljanje citotoksičnosti in vitro (ISO 10993-5:2009)

General Information

• Status: Published
• Publication Date: 31-May-2009
• Withdrawal Date: 30-Dec-2009
• 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: 01-Jun-2009
• Completion Date: 01-Jun-2009
• 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 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Relations

• Replaces: EN ISO 10993-5:1999 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
• Effective Date: 06-Jun-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-5:2009
01-september-2009
1DGRPHãþD
SIST EN ISO 10993-5:2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO3UHVNXVL]DXJRWDYOMDQMH
FLWRWRNVLþQRVWLLQYLWUR,62
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993
-5:2009)
Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf in vitro-
Zytotoxizität (ISO 10993-5:2009)
Évaluation biologique des dispositifs médicaux - Partie 5: Essais concernant la
cytotoxicité in vitro (ISO 10993-5:2009)
Ta slovenski standard je istoveten z: EN ISO 10993-5:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-5:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-5:2009

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SIST EN ISO 10993-5:2009
EUROPEAN STANDARD
EN ISO 10993-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.100.20 Supersedes EN ISO 10993-5:1999
English Version
Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity (ISO 10993-5:2009)
Évaluation biologique des dispositifs médicaux - Partie 5: Biologische Beurteilung von Medizinprodukten - Teil 5:
Essais concernant la cytotoxicité in vitro (ISO 10993- Prüfungen auf In-vitro-Zytotoxizität (ISO 10993-5:2009)
5:2009)
This European Standard was approved by CEN on 17 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 10993-5:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10993-5:2009
EN ISO 10993-5:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Annex ZB (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 90/385/EEC .5

2

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SIST EN ISO 10993-5:2009
EN ISO 10993-5:2009 (E)
Foreword
This document (EN ISO 10993-5:2009) has been prepared by Technical Committee ISO/TC 194 "Biological
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 December 2009, and conflicting national standards shall be withdrawn
at the latest by December 2009.
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 10993-5:1999.
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 EC Directives.
For relationship with EC 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 of the following
countries are bound to implement this European Standard: Austria, B
...