AS ISO 11135-2002 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization PDF
AS ISO 11135-2002 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization PDF
AS ISO 11135-2002 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization PDF
ISO 11135:1994
AS ISO 11135
Australian Standard™
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
Australian Standard™
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
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 4706 X
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-023 on Processing of medical and surgical instruments.
This Standard is identical with and has been reproduced from ISO 11135:1994, Medical
devices — Validation and routine control of ethylene oxide sterilization and Technical
Corrigendum 1 has been incorporated.
The objective of this Standard is to specify the requirements and guidance for validation
and routine control of ethylene oxide sterilization processes for medical devices.
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
iii
CONTENTS
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iv
CONTENTS
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INTRODUCTION
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1
AUSTRALIAN STANDARD