DIN EN ISO 14698-2 Berichtigung 1-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2 Evaluation and interpretation of biocontamination data .pdf

1、July 2010 Translation by DIN-Sprachendienst.English price group 99No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1

2、3.040.35!$jqCorrigendum 1 to English translation of DIN EN ISO 14698-2:2004-02Reinrume und zugehrige Reinraumbereiche Biokontaminationskontrolle Teil 2: Auswertung und Interpretation von Biokontaminationsdaten (ISO 14698-2:2003);Berichtigung 1 zur englischen bersetzung DIN EN ISO 14698-2:2004-02Sall

3、es propres et environnements matriss apparents Matrise de la biocontamination Partie 2: valuation et interprtation des donnes de biocontamination(ISO 14698-2:2003);Corrigendum 1 la traduction anglaise de DIN EN ISO 14698-2:2004-02www.beuth.deDocument comprises pagesIn case of doubt, the German-langu

4、age original shall be considered authoritative.209.10 DIN EN ISO 14698-2 Cor. 1:2010-07 This Corrigendum is based on EN ISO 14698-2:2003/AC:2006. In the English version of DIN EN ISO 14698-2:2004-02 the following corrections are to be made: Re Foreword Insert the following: Endorsement notice The te

5、xt of ISO 14698-2:2003/Cor.1:2004 has been approved by CEN as a European Corrigendum without any modification . sRe Subclause 3.1 Delete the word “microbiological” from the definition “microbiological level.,” such that it now reads as follows: “level set by the user in the context of controlled env

6、ironments, which, when exceeded, required immediate intervention, including investigation of cause, and corrective action” Re Subclause 3.2 Replace the existing definition with the following (to be consistent with ISO 14698-1:2003, 3.1.2, the note remains unchanged): “level set by the user in the co

7、ntext of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, should result in increased attention to the process” Re Subclause 3.10 Replace the existing definition with the following: “potential source of harm ISO/IEC Guide 51:1999, 3.58” Re Subclause 3.13 Replace the existing definition with the following (to be consistent with ISO 14698-1:2003, 3.1.20): “defined level set by the user as a goal for routine operations, for the users own purpose” 2