EN ISO 10993-9:2009

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.

Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:1999)

Dieser Teil von ISO 10993 beschreibt allgemeine Prinzipien zur systematischen Beurteilung von möglichen und beobachteten biologischen Abbauvorgängen bei Medizinprodukten sowie zur Planung und Durchführung von Studien zum biologischen Abbau. Informationen, die aus diesen Studien resultieren, können für die in der Normenreihe ISO 10993 beschriebene biologische Beurteilung verwendet werden. Dieser Teil der ISO 10993 betrachtet sowohl nicht-resorbierbare als auch resorbierbare Materialien.
Dieser Teil von ISO 10993 ist nicht anwendbar für:
a)   eine Beurteilung des Abbaus durch rein mechanische Prozesse. Methoden zur Generierung dieser Art von Abbauprodukten sind, falls vorhanden, in den spezifischen Produktnormen beschrieben;
ANMERKUNG 1   Rein mechanischer Abbau verursacht meist partikelförmiges Material. Obwohl dieses aus dem Anwendungsbereich dieses Teils der ISO 10993 ausgeschlossen ist, können solche Abbauprodukte eine biologische Reaktion hervorrufen und müssen daher einer biologischen Beurteilung, wie in anderen Teilen der ISO 10993 beschrieben, unterzogen werden.
b)   herauslösbare Komponenten, die keine Abbauprodukte sind;
c)   Medizinprodukte oder deren Komponenten, die weder direkt noch indirekt mit dem Körper des Patienten in Berührung kommen.
ANMERKUNG 2   Dieser Teil der ISO 10993 kann für den Materialabbau in jedem Produkt, das unter die Definition „Medizinprodukt“ in ISO 10993-1 fällt, angewendet werden. Dies gilt auch, wenn solche Produkte anderen Bestimmungen unterliegen als denen, die für Medizinprodukte gelten, wie z. B. strukturbildende Materialien in einem medizinischen Produkt auf Basis des Tissue Engineering oder Trägermaterialien, mit Hilfe derer Arzneimittel oder biologische Präparate appliziert werden.

Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation (ISO 10993-9:1999)

L'ISO 10993-9:2009 donne les principes généraux pour l'évaluation systématique de la dégradation potentielle et observée des dispositifs médicaux et pour la conception et l'exécution des études de biodégradation. Les informations obtenues de ces études peuvent servir aux évaluations biologiques décrites dans la série de l'ISO 10993. L'ISO 10993-9:2009 aborde à la fois les matériaux résorbables et non résorbables.

Biološko ovrednotenje medicinskih pripomočkov - 9. del: Okvirni sistem za prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO 10993-9:2009)

Ta del ISO 10993 zagotavlja splošna načela za sistematično ovrednotenje morebitne in opažene biorazgradnje medicinskih pripomočkov ter za zasnovo in izvajanje študij biorazgradnje. Informacije, pridobljene na podlagi teh študij, se lahko uporabljajo pri biološkem vrednotenju, opisanem v seriji ISO 10993. Ta del ISO 10993 obravnava neabsorptivne in absorptivne materiale. Ta del ISO 10993 ne velja za: a) vrednotenje razgradnje, do katere pride zaradi popolnoma mehanskih procesov; če so na voljo, so metodologije za nastanek tovrstnih razgradnih proizvodov opisane v specifičnih standardih za proizvode.

General Information

• Status: Withdrawn
• Publication Date: 19-May-2009
• Withdrawal Date: 14-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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Dec-2009
• Completion Date: 15-Dec-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 10993-9:2010 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

Relations

• Replaces: EN ISO 10993-9:1999 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10993-9:2021 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
• Effective Date: 06-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-9:2010
01-marec-2010
1DGRPHãþD
SIST EN ISO 10993-9:2009
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2NYLUQLVLVWHP]D
SUHSR]QDYDQMHLQXJRWDYOMDQMHNROLþLQHPRUHELWQLKUD]JUDGQLKSURGXNWRY,62

Biological evaluation of medical devices - Part 9: Framework for identification and
quantification of potential degradation products (ISO 10993-9:2009)
Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und
Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:2009)
Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la
quantification des produits potentiels de dégradation (ISO 10993-9:2009)
Ta slovenski standard je istoveten z: EN ISO 10993-9:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-9:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-9:2010

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SIST EN ISO 10993-9:2010


EUROPEAN STANDARD
EN ISO 10993-9

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2009
ICS 11.100.20 Supersedes EN ISO 10993-9:2009
English Version
Biological evaluation of medical devices - Part 9: Framework for
identification and quantification of potential degradation products
(ISO 10993-9:2009)
Évaluation biologique des dispositifs médicaux - Partie 9: Biologische Beurteilung von Medizinprodukten - Teil 9:
Cadre pour l'identification et la quantification des produits Rahmen zur Identifizierung und Quantifizierung von
potentiels de dégradation (ISO 10993-9:2009) möglichen Abbauprodukten (ISO 10993-9:2009)
This European Standard was approved by CEN on 18 November 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 10993-9:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10993-9:2010
EN ISO 10993-9:2009 (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 10993-9:2010
EN ISO 10993-9:2009 (E)
Foreword
This document (EN ISO 10993-9:2009) 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 June 2010, and conflicting national standards shall be withdrawn at
the latest by June 2010.
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 10993-9:2009.
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
...