ISO-14161-2000.pdf
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1、Reference number ISO 14161:2000(E) ISO 2000 INTERNATIONAL STANDARD ISO 14161 First edition 2000-10-01 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results Strilisation des produits de sant Indicateurs biologiques Directives gnrales
2、 pour la slection, lutilisation et linterprtation des rsultats Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 23:16:09 MDTNo reproduction or networking permitted without license
3、 from IHS -,-,- ISO 14161:2000(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes 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 e
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6、at the address given below. ISO 2000 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address be
7、low or ISOs 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 copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2000 All rights reserved Copyright International Organization for Standar
8、dization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 23:16:09 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14161:2000(E) ISO 2000 All rights reservediii ContentsPage Forewordv Introductionvi 1Scope
9、1 2Normative references1 3Terms and definitions .2 4General4 5Characteristics of biological indicators 6 5.1General6 5.2Test organism suspension for direct inoculation of products .6 5.3Inoculated carriers.7 5.4Biological indicators .7 6Selection of supplier .8 6.1General8 6.2Documentation.9 7Biolog
10、ical indicators in process development.10 7.1General10 7.2Reference microorganism method 11 7.3Combined biological indicator and bioburden method.11 7.4Bioburden method.12 8Biological indicators in sterilization validation13 8.1General13 8.2Placement and handling of biological indicators.13 8.3Steri
11、lizer qualification .13 8.4Performance qualification.13 8.5Review and approval of validation.14 8.6Requalifications.14 9Biological indicators in routine monitoring14 9.1General14 9.2Placement and handling of biological indicators.14 9.3Process challenge device (PCD)15 10Results15 10.1General15 10.2I
12、nterpretation of results 15 11Application of biological indicator standards 16 11.1General assessment of biological indicator performance by the user16 11.2Nominal population of test organism17 11.3D-value determination.17 11.4Testing equipment.19 12Culture conditions.20 12.1General20 12.2Incubation
13、 temperature.20 12.3Incubation period.20 12.4Choice of growth medium.21 13Third-party requirements21 13.1General21 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 23:16:09 MDTNo
14、reproduction or networking permitted without license from IHS -,-,- ISO 14161:2000(E) iv ISO 2000 All rights reserved 13.2Minimum requirements for replicates and total number of biological indicators.22 13.3Test equipment 22 14Personnel training .22 15Storage and handling23 16Disposal of biological
15、indicators .23 Annex A (informative) Microbiological inactivation kinetics and enumeration techniques24 Annex B (informative) Process challenge devices 28 Annex C (informative) Formulae for fraction negative methods for D-value calculations 29 Annex D (informative) Examples of documentation of biolo
16、gical indicators collected by the user 35 Bibliography39 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 23:16:09 MDTNo reproduction or networking permitted without license from
17、IHS -,-,- ISO 14161:2000(E) ISO 2000 All rights reservedv 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 committe
18、es. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Inte
19、rnational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bod
20、ies 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 International Standard may be the subject of patent rights. ISO shall not be held responsible for i
21、dentifying any or all such patent rights. International Standard ISO 14161 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. Annexes A, B, C and D of this International Standard are for information only. Copyright International Organization for Standardization Pr
22、ovided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 23:16:09 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14161:2000(E) vi ISO 2000 All rights reserved Introduction This International Standard provides guidan
23、ce regarding the selection, use and interpretation of results of biological indicators when used to develop, validate and monitor sterilization processes. The procedures described in this document are of a general nature and do not, of themselves, constitute a comprehensive development, validation,
24、or monitoring programme with regard to the sterilization of health care products. The intent of this International Standard is not to mandate the use of biological indicators in a process, but, if they are used, to provide guidance for their proper selection and use, to avoid misleading results. Bio
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