ISO-22610-2006.pdf
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1、 Reference number ISO 22610:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 22610 First edition 2006-07-01 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration Champs chirurgic
2、aux, casaques et tenues de bloc, utiliss en tant que dispositifs mdicaux, pour les patients, le personnel et les quipements Mthode dessai de rsistance la pntration de la barrire bactrienne ltat humide Copyright International Organization for Standardization Provided by IHS under license with ISO Lic
3、ensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printe
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6、uitable 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 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
7、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 postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mai
8、l copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or network
9、ing permitted without license from IHS -,-,- ISO 22610:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Principle. 2 5 Reagents and materials 3 6 Apparatus 3 7 Preparation of test samples and pieces.
10、3 7.1 Agar plates 3 7.2 Carrier material . 4 7.3 Test specimen. 4 8 Procedure 4 8.1 Preparation of donor 4 8.2 Conditioning 4 8.3 Test set-up. 4 8.4 Application of materials. 4 8.5 Test. 5 9 Test report . 5 10 Performance monitoring 6 10.1 General. 6 10.2 With carbon paper 6 10.3 With reference mate
11、rial 6 Annex A (normative) Apparatus for testing resistance to wet bacterial penetration 7 Annex B (normative) Nutrient media 10 Annex C (informative) Examples of how to use the test results to characterize a barrier material 12 Bibliography. 14 Copyright International Organization for Standardizati
12、on Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 22610:2006(E) iv ISO 2006 All rights reserved Foreword ISO (the International Organization for St
13、andardization) 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 established has the rig
14、ht 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 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International
15、 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 International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as a
16、n 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
17、22610 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in collaboration with Technical Committee ISO/TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 13, Protective clothing, in accordance with the A
18、greement on technical cooperation between ISO and CEN (Vienna Agreement). Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted with
19、out license from IHS -,-,- ISO 22610:2006(E) ISO 2006 All rights reserved v Introduction There are numerous examples of situations where bacteria carried by a liquid may migrate through a barrier material in the wet state. The wet penetration of skin flora through a covering material is one example.
20、 European Medical Device regulations specifically place the responsibility for avoiding device-related infections on the manufacturer. In order to demonstrate compliance with this requirement and to describe a product to the user, there is a need to use harmonized and recognized international test m
21、ethods. The test method described in this international standard uses microbiological techniques and is therefore intended to be performed exclusively by laboratories experienced in and equipped for such work. Copyright International Organization for Standardization Provided by IHS under license wit
22、h ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/99725
23、45001 Not for Resale, 04/19/2007 02:09:56 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 22610:2006(E) ISO 2006 All rights reserved 1 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment
24、Test method to determine the resistance to wet bacterial penetration WARNING The use of this standard may involve hazardous materials, operations and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this
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