ISO-11140-1-2005.pdf
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1、 Reference number ISO 11140-1:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 11140-1 Second edition 2005-07-15 Sterilization of health care products Chemical indicators Part 1: General requirements Strilisation des produits de sant Indicateurs chimiques Partie 1: Exigences gnrales Copyright Internation
2、al Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) PDF disclaimer This PDF file may contain embedde
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5、e 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. ISO 2005 All rights reserved. Unless otherwise specifi
6、ed, 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 country of the requester. ISO copyright office Case
7、 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 2005 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standard
8、s 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) ISO 2005 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Classification
9、. 3 5 General requirements. 4 6 Performance requirements 6 7 Test methods. 7 8 Additional requirements for process (Class 1) indicators . 10 9 Additional requirements for single variable (Class 3) indicators 13 10 Additional requirements for multi-variable (Class 4) indicators 13 11 Additional requi
10、rements for steam integrating (Class 5) indicators. 14 12 Additional requirements for dry heat integrating (Class 5) indicators . 14 13 Additional requirements for ethylene oxide integrating (Class 5) indicators 15 14 Additional requirements for emulating (Class 6) indicators 16 Annex A (informative
11、) Method for demonstrating shelf life of the product . 17 Annex B (informative) Examples of testing indicators. 18 Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in ISO 11138 and microbial ina
12、ctivation 19 Annex D (informative) Rationale for the liquid-phase test method for steam-formaldehyde indicators. 25 Annex E (informative) Relationship of indicator components. 26 Bibliography. 27 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee
13、=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) iv ISO 2005 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of nati
14、onal 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 established has the right to be represented on that committee. Internat
15、ional organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the ru
16、les given in the ISO/IEC 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
17、 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 11140-1 was prepared by Technical Committee ISO/
18、TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11140-1:1995 and ISO 11140-1:1995/Amd.1:1998), which has been technically revised. ISO 11140 consists of the following parts, under the general title Sterilization of health care products C
19、hemical indicators: Part 1: General requirements Part 2: Test equipment and methods Part 3: Class 2 indicators for steam penetration test sheets Part 4: Class 2 indicators for steam penetration test packs Part 5: Class 2 indicators for air removal test sheets and packs NOTE ISO 11140-2 is to be repl
20、aced by ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reprodu
21、ction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) ISO 2005 All rights reserved v Introduction This part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat,
22、ethylene oxide, or radiation, steam-formaldehyde or vaporized hydrogen peroxide. Additional requirements for indicators intended for use with other sterilization methods (e.g. other forms of moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general requi
23、rements will apply. The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of ISO 11140. Standards for sterilizers and for the validation and process control of sterilization, describe performance tests for sterilizers and methods of validation and
24、 routine control, respectively. This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general requirements for chemical indicators. Subsequent parts of this International Standard specify the particular requirements for chemical indicators for particular appli
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