ISO INTERNATIONAL STANDARD 14644-2 Secondedition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Salles propres et environnements maitrisés apparentés - Partie 2: Surveillance du maintien des performances de la salle propre pour la proprete particulaire de I'air Reference number ISO 14644-2:2015(E) ISO International Organization for Standardization @ IS0 2015 STANDARDIZATIONC15956617 ed without license from IHS IS0 14644-2:2015(E) COPYRIGHT PROTECTED DOCUMENT IS0 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 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 copyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org Internatinir DrganizationforStandardization Licensee-ZHEJIANG INST OF STANDARDIZzRoISQ5 - All rights reserved No reproduction or networking permited without license from IHS IS0 14644-2:2015(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions 4 Creating, implementing and maintaining a monitoring plan .2 4.1 Principle. .2 4.2 Riskassessment .2 4.3 Monitoring plan. .3 4.4 Calibration ..3 4.5 Review and approval 4 4.6 Response to a deviation during monitoring .4 5 Periodic classification of air cleanliness by particle concentration ..4 Annex A (informative) Matters to consider when developing a monitoring plan Annex B (informative) Considerations for setting alert and action levels .9 Bibliography ..14 ii See=ZHEJIANG INST OF STANDARDIZATION C1 5956617 thout license from IHS