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)

This part of ISO 10993 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.  This part of ISO 10993 is not applicable to:  a) viable-tissue engineered products; b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available; c) leachable components wich are not degradation products.  Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.

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 Biodegradationen von Medizinprodukten und für die Auslegung und die Leistung von Biodegradationsstudien. Dieser Teil von ISO 10993 ist nicht anwendbar für: a) aus lebendem Gewebe entworfene Produkte; b) Methoden zur Erzeugung von Abbauprodukten durch mechanische Prozesse. Methoden zur Erzeugung dieser Art von Abbauprodukten sind in den jeweiligen Produktnormen, falls vorhanden, beschrieben; c) herauslösbare Komponenten, die keine Abbauprodukte sind.

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

Biološko ovrednotenje medicinskih pripomočkov - 9. del: Okvirni sistem za prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO 10993-9:1999)

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-1999
• Withdrawal Date: 19-May-2009
• ICS: 11.100 - Laboratory medicine
• 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: 20-May-2009
• Completion Date: 20-May-2009
• 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 10993-9:2000 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

Relations

• Replaced By: 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)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-9:2000
01-januar-2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO2NYLUQLVLVWHP]D
SUHSR]QDYDQMHLQXJRWDYOMDQMHNROLþLQHPRUHELWQLKUD]JUDGQLKSURGXNWRY,62

Biological evaluation of medical devices - Part 9: Framework for identification and
quantification of potential degradation products (ISO 10993-9:1999)
Biologische Beurteilung von Medizinprodukten - Teil 9: Rahmen zur Identifizierung und
Quantifizierung von möglichen Abbauprodukten (ISO 10993-9:1999)
Evaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la
quantification des produits potentiels de dégradation (ISO 10993-9:1999)
Ta slovenski standard je istoveten z: EN ISO 10993-9:1999
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-9:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 10993-9
First edition
1999-03-01
Biological evaluation of medical devices —
Part 9:
Framework for identification and quantification
of potential degradation products
Évaluation biologique des dispositifs médicaux —
Partie 9: Cadre pour l'identification et la quantification des produits
potentiels de dégradation
A
Reference number
ISO/FDIS 10993-9:1999(E)

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ISO 10993-9:1999(E)
Contents
Page
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Principles for design of degradation studies.2
4.1 General.2
4.2 Preliminary considerations.2
4.3 Study design .3
4.4 Characterization of degradation products from medical devices .3
5 Study report.3
Annex A (normative) Consideration of the need for degradation studies .5
Annex B (informative) Biodegradation study considerations .6
Bibliography.8
©  ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
Printed in Switzerland
ii

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©
ISO ISO 10993-9:1999(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 10993-9 was prepared by Technical Committee ISO/
...