ANSI ST15883-2-2013 Washer-disinfectors - Part 2 Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments anesthetic equipment bowls d.pdf

1、ANSI/AAMI/ST15883-2: 2013(ISO 15883-2:2006, MOD) Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.American National StandardObjectives and uses

2、of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical inst

3、rumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancem

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24、dical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI Ne

25、ws. American National Standard ANSI/AAMI ST15883-2:2013 (ISO 15883-2:2006, MOD) Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. Approved 3 Dec

26、ember 2012 by Association for the Advancement of Medical Instrumentation Approved 9 January 2013 by American National Standards Institute, Inc. Abstract: This document specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection,

27、in a single operating cycle, of re-usable medical devices such as surgical instruments, anesthetic equipment, bowls, dishes and receivers, utensils and glassware. Keywords: ISO 15883-2 AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus o

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31、y AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible fo

32、r enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subj

33、ect to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under

34、federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and

35、damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United Stat

36、es of America ISBN 1-57020-481-0 Contents Page Glossary of equivalent standards iv Committee representation v Background of ANSI/AAMI adoption of ISO 15883-2:2006 viii U.S. Deviations to ISO 15883-2:2006 ix Foreword . xiv Introduction . xv 1 Scope. 1 2 Normative references 1 3 Terms and definitions

37、2 4 Performance requirements . 3 4.1 General 3 4.2 Cleaning 4 4.3 Disinfecting . 4 4.4 Temperature of internal surfaces of processed devices . 5 5 Mechanical and control requirements . 5 5.1 Load connectors 5 5.2 Control systems . 6 5.3 Process verification . 6 6 Testing for conformity . 6 6.1 Gener

38、al 6 6.2 Tests for soil removal from chamber walls, load carrier and load . 6 6.3 Thermometric tests 7 7 Information to be supplied by the manufacturer 9 8 Information to be requested from the purchaser by the supplier of the WD . 9 Annex A (informative) Summary of test programs 11 Bibliography 12 i

39、v 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-2:2013 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Stan

40、dard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2013 Association for the Advancement of Medical Instrument

41、ation ANSI/AAMI ST15883-2:2013 v Committee representation Association for the Advancement of Medical Instrumentation Washer-disinfectors Working Group The adoption of ISO 15883-2 as an American National Standard was initiated by the AAMI Washer-disinfectors Working Group of the AAMI Sterilization St

42、andards Committee. The AAMI Washer-disinfectors Working Group also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Sterilization (ISO). U.S. representatives from the AAMI Washer-disinfectors Working Group (U.S. Sub-TAG for ISO/TC 198/WG 13) pla

43、yed an active part in developing the ISO standard. At the time this document was published, the AAMI Washer-disinfectors Working Group had the following members: Cochairs: Kevin Corrigan, Johnson powered devices; instrument trays; instruments for minimally invasive surgery; lumen devices and tubing;

44、 rigid endoscopes; anesthetic and respiratory equipment; bowls, dishes and receivers; glassware; containers for transit. Fields of application within the scope of the ISO AAMI ST15883 series of standards include laboratory, veterinary, dental and pharmaceutical applications and other specific applic

45、ations, such as washer-disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts of the ISO AAMI ST15883 series of st

46、andards. When processed in the instrument washer-disinfector, the medical devices might be intended for immediate use or might be intended for packing and sterilization. In both cases, the efficacy of the cleaning and disinfection is of major importance. In either case, this is for the well being of

47、 the patient. In the latter case, it is also for the safety of the staff who handles the instruments in the process of inspection, testing and packing as well as ensuring that the sterilization process is not unduly challenged by residual soil. The efficacy of disinfection can be impaired if soil re

48、moval is incomplete before the start of the disinfection process. Users should be aware that sSome medical devices might require pre-treatment e.g. soaking, brushing, ultrasonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should be made to the medical manufacture

49、rs instructions for reprocessing (see also ISO 17664 or ANSI/AAMI ST81). xvi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-2:2013 Safety requirements for washer-disinfectors are given in IEC 61010-2-0405. Requirements for the quality of water employed to process surgical instruments and related devices are found in AAMI TIR34. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors: a) it should be noted that, until verifiable European crite