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Medical Device White Paper Series Sterilization ...

Medical Device White Paper Series Sterilization Regulatory requirements and supporting standards Author - Eamonn Hoxey, technical author, trainer and consultant Sterilization Regulatory requirements and supporting standards Disclaimer This White Paper is issued for information only. It does not constitute an official or agreed position of BSI Standards Ltd. The views expressed are entirely those of the authors. All rights reserved. Copyright subsists in all BSI publications including, but not limited to, this White Paper . Except as permitted under the Copyright, Designs and Patents Act 1988, no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise.

Devices Regulation and the Medical Devices Directive 1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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