ISO INTERNATIONAL STANDARD 14698-1 First edition 2003-09-01 Cleanrooms and associated controlled environments Biocontamination control - Part 1: General principles and methods Salles propres et environnements maitrisés apparentes Maitrise de labiocontamination- Partie 1: Principes généraux et méthodes Reference number ISO 14698-1:2003(E) ISO @ ISO 2003 y IHS under ted without license from IHS Not for Resale ISO 14698-1:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The IsO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, IsO's member body in the country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2003 - All rights reserved ermittedwithoutlicense from IHS Not for Resale ISO 14698-1:2003(E) Contents Page Foreword iv Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Principles of biocontamination control. 5 Establishing the Formal System 6 Expression,interpretationandreportingofresults.. 10 7 Verification of the Formal System.. 8 Training... 9 Documentation. Annex A (informative) Guidance on determining airborne biocontamination .. Annex B (informative) Guidance on validating air samplers Annex C (informative) Guidance on determining biocontamination of surfaces .. Annex D (informative) Guidance on determining biocontamination of textiles ... 20 Annex E (informative) Guidance on validating laundering processes.. Annex F (informative) Guidance on determining biocontamination of liquids ... Annex G (informative) Guidance on training Bibliography Copyrght International Organizaionforstandardizationrights reserved ili from IHS Not for Resale ISO 14698-1:2003(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been non-governmental, in liaison with isO, also take part in the work. iso collaborates closely with the InternationalElectrotechnicalCommission(lEC)onallmattersofelectrotechnicalstandardization. International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 14698-1 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. IsO 14698 consists of the following parts, under the general ti