ISO-18472-2006.pdf
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1、 Reference number ISO 18472:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 18472 First edition 2006-06-01 Sterilization of health care products Biological and chemical indicators Test equipment Strilisation des produits de sant Indicateurs biologiques et chimiques Appareillage dessai ISO 18472:2006(E)
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5、06 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 below or ISOs member body in the cou
6、ntry 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.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved ISO 18472:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Int
7、roduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Performance requirements for resistometers . 4 4.1 Intended use 4 4.2 Measurement and control capabilities . 4 4.3 Test methods. 4 4.4 Leak test 4 4.5 Steam resistometer performance requirements 4 4.6 Ethylene oxide resis
8、tometer performance requirements. 7 4.7 Dry heat (heated air) resistometer performance requirements . 9 4.8 Vaporized hydrogen peroxide process resistometer performance requirements. 11 5 Recording systems. 12 5.1 Measurement systems . 12 5.2 Calibration . 12 6 Documentation 12 6.1 General. 12 6.2 M
9、inimum information . 13 Annex A (informative) Additional performance characterization Steam . 14 Annex B (informative) Additional performance characterization Ethylene oxide. 17 Annex C (informative) Additional performance characterization Dry heat . 20 Annex D (informative) Resistometer documentati
10、on and derivations 22 Bibliography. 28 -,-,- ISO 18472:2006(E) iv ISO 2006 All rights reserved 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 carri
11、ed out through ISO technical committees. 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. I
12、SO collaborates closely with the International 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 2. The main task of technical committees is to prepare Internati
13、onal 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 el
14、ements 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 18472 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This first edition of ISO 18472 partially replaces ISO 11140-
15、2. ISO 18472:2006(E) ISO 2006 All rights reserved v Introduction To test the performance of chemical and biological indicators, specific test equipment is required. This International Standard specifies the performance requirements for the test equipment to be used in order to establish the response
16、 of chemical and biological indicators to critical process variables. This International Standard does not apply to test equipment for irradiation indicators or low temperature steam and formaldehyde indicators. Resistometers constitute test equipment designed to create precise and repeatable steril
17、izing environments, allowing the evaluation of their effect on biological inactivation kinetics, chemical reactions, material degradation and product bioburden. Resistometers allow precise variation of the environmental conditions and cycle sequences in order to produce controlled physical studies.
18、When used with the defined test methods given in ISO 11138 for biological indicators and ISO 11140 for chemical indicators, the results of these studies can be used to demonstrate conformance of biological indicators and chemical indicators to these standards. Resistometers differ from conventional
19、sterilizers. Instrumentation selection and control requirements for resistometers are based upon mathematical models in which rates of reaction, measurement accuracy and process control requirements are evaluated to quantify the effects induced by test equipment-controlled variables. The requirement
20、s for accurate measurement, precise control, and rapid rates of change approach limits of commercially available process control and calibration instrumentation accuracy. The measurement and control requirements often prohibit practical validation of a resistometer using procedures that might be emp
21、loyed in a conventional heat or chemical sterilization system. Resistometers are considered test equipment rather than sterilizers; therefore, an understanding of instrumentation and process design is critical in clarifying requirements on precision and accuracy. Practical design has to consider the
22、 following: achievable measurement and control; acceptable equipment induced variation in test results; economic design (utilizing tight process controls only where required); test method correlation with intended use; historical knowledge applied to test procedures and an understanding of micro-env
23、ironmental physical phenomena; testing and analysis alternatives, when accurate quantitative determinations exceed physical measurement/control limits. -,-,- INTERNATIONAL STANDARD ISO 18472:2006(E) ISO 2006 All rights reserved 1 Sterilization of health care products Biological and chemical indicato
24、rs Test equipment 1 Scope 1.1 This International Standard specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chem
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