SIST EN ISO 10993-9:2000

SLOVENSKI STANDARD
SIST EN ISO 10993-9:2000
01-januar-2000
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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 iso@iso.ch
Printed in Switzerland
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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/TC 194, Biological evaluation of
medical devices.
This first edition cancels and replaces the first edition of ISO/TR 10993-9:1994, which has been technically revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
 Part 1: Evaluation and testing
 Part 2: Animal welfare requirements
 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
 Part 4: Selection of tests for interactions with blood
 Part 5: Tests for in vitro cytotoxicity
 Part 6: Tests for local effects after implantation
 Part 7: Ethylene oxide sterilization residuals
 Part 9: Framework for the identification and quantification of potential degradation products
 Part 10: Tests for irritation and sensitization
 Part 11: Tests for systemic toxicity
 Part 12: Sample preparation and reference materials
 Part 13: Identification and quantification of degradation products from polymers
 Part 14: Identification and quantification of degradation products from ceramics
 Part 15: Identification and quantification of degradation products from metals and alloys
 Part 16: Toxicokinetic study design for degradation products and leachables
 Part 18: Chemical characterization.
Further parts will deal with other relevant aspects of biological testing.
Annex A forms a normative part of this part of ISO 10993. Annex B is for information only.
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©
ISO 10993-9:1999(E) ISO
Introduction
This part of 10993 is intended to present the general principles on which the specific material investigations to
identify and quantify degradation products described in ISO 10993-13 (polymers), ISO 10993-14 (ceramics) and
ISO 10993-15 (metals and alloys) are based.
Information obtained from these studies is intended to be used in the biological evaluations described in the
remaining parts of ISO 10993.
The materials used to construct medical devices may form degradation products when exposed to the biological
environment, and these products may behave differently than the bulk material in the body.
Degradation products can be generated in different ways, either mechanically (by relative motion between two or
more different components), by fatigue loading, as a result of fracture and/or by release from the medical device
due to interactions with the environment, or combinations thereof.
Mechanical wear causes mostly particulate debris, whereas the release of substances from surfaces due to
leaching, chemical breakdown of structures or corrosion can lead to free ions or to different kinds of reaction
products in the form of organic or inorganic compounds.
The degradation products may be either reactive, or stable and without biochemical reaction with their environment.
Accumulations of substantial quantities of stable degradation products may, however, have physical effects on the
surrounding tissues. Degradation products may remain at the location of their generation or may be transported
within the biological environment by various mechanisms.
The level of biological tolerability of degradation products depends on their nature and concentration, and should be
primarily assessed through clinical experience and focused studies. For theoretically possible, new and/or unknown
degradation products, relevant testing is necessary. For well-described and clinically accepted degradation prod-
ucts, no further investigation may be necessary.
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©
INTERNATIONAL STANDARD  ISO ISO 10993-9:1999(E)
Biological evaluation of medical devices —
Part 9:
Framework for identification and quantification of potential degradation
products
1 Scope
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 which 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.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 10993. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 10993 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing.
ISO 10993-2:1992, Biological evaluation of medical devices — Part 2: Animal welfare requirements.
3 Terms and definiti
...