ISO/TS TECHNICAL SPECIFICATION 21387 First edition 2020-09 Sterilization of medical devices Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release Stérilisation des dispositifs medicaux Lignes directrices concernant les exigences de validation et de traitement de routine des procédés de sterilisation a I'oxyde d'ethylene par libération paramétrique Reference number IS0/TS 21387:2020(E) ISO @ISO2020 IS0/TS 21387:2020(E) COPYRIGHT PROTECTED DOCUMENT @ iS02020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2020 - All rights reserved