AS ISO 10993.

9—2002
ISO 10993-9:1999
AS ISO 10993.9

Australian Standard™
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Biological evaluation of medical devices

Part 9: Framework for identification and

quantification of potential degradation
products
 This Australian Standard was prepared by Committee HE-012, Surgical Implants. It
was approved on behalf of the Council of Standards Australia on 26 June 2002 and
published on 28 June 2002.

The following are represented on Committee HE-012:

Australian Chamber of Commerce and Industry
Australian College of Operating Room Nurses
Australian Dental Association
Australian Industry Group
Australian Orthopaedic Association
Commonwealth Department of Health and Ageing
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Department of Defence (Australia)

Medical Industry Association of Australia Inc
Neurological Society of Australasia
Royal Australasian College of Surgeons
Royal Perth Hospital
The Australian Society for Biomaterials
The University of New South Wales
The University of Sydney

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Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW
2001.

This Standard was issued in draft form for comment as DR 02206.

 AS ISO 10993.9—2002

Australian Standard™
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Biological evaluation of medical devices

Part 9: Framework for identification and

quantification of potential degradation
products

First published as AS ISO 10993.9—2002.

COPYRIGHT
© Standards Australia International
All rights are reserved. No part of this work may be reproduced or copied in any form or by any
means, electronic or mechanical, including photocopying, without the written permission of the
publisher.
Published by Standards Australia International Ltd
GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 4697 7
 ii

PREFACE
This Standard has been developed to assist in the process of implementation of the
Australian Medical Device legislation.
After consultation with stakeholders in both countries, Standards Australia and Standards
New Zealand decided to develop this Standard as an Australian, rather than an
Australian/New Zealand Standard, through the Joint Standards Australia/Standards
New Zealand Committee HE-012 on Surgical Implants.
This Standard is identical with and has been reproduced from ISO 10993-9:1999, Biological
evaluation of medical devices — Part 9: Framework for identification and quantification of
potential degradation products.
The objective of this Standard is to provide general principles for the systematic evaluation
of the potential and observed biodegradation of medical devices and for the design and
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

performance of biodegradation studies.

As this Standard is reproduced from an international Standard, the following applies:
(a) Its number does not appear on each page of text and its identity is shown only on the
cover and title page.
(b) In the source text ‘this International Standard’ should read ‘this Australian Standard’.
(c) A full point substitutes for a comma when referring to a decimal marker.
 iii

CONTENTS

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

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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
 iv

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
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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.
 1

AUSTRALIAN STANDARD

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.
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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 definitions

For the purposes of this part of ISO 10993, the terms and definitions given in ISO 10993-1 and the following apply.

3.1
degradation
decomposition of a material

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 This is a free preview. Purchase the entire publication at the link below:

AS ISO 10993.9-2002, Biological evaluation of

medical devices Framework for identification and
quantification of potential degradation products
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

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