ANSI ST15883-1-2009 Washer-disinfectors - Part 1 General requirements terms and definitions and tests (Incorporates Amendment 1 2006 and Amendment 2 2009).pdf

1、ANSI/AAMI ST15883-1: 2009/(R)2014(ISO 15883-1:2006, MOD) Washer-disinfectors Part 1: General requirements,terms and definitions and testsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI pr

2、oduct standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of curr

3、ent 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 advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that a

4、rbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measu

5、rement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance charac

6、teristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods t

7、o facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reason

8、s for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help en

9、sure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even

10、 though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidel

11、ines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices.

12、In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulato

13、ry or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and in

14、dustrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended

15、 practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decisi

16、on-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specif

17、ic rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and

18、 practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a

19、particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in t

20、he context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful

21、 only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in

22、writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Associat

23、ion only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended p

24、ractice 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 News. American National Standard ANSI/AAMI ST15883-1:2009/(R)2014 (ISO 15883-1:2006, MOD) Washer-disinfectors Part 1: G

25、eneral requirements, terms and definitions and tests Developed by Association for the Advancement of Medical Instrumentation Approved 15 September 2009 and reaffirmed 26 September 2014 by American National Standards Institute, Inc. Abstract: This document specifies general performance requirements f

26、or washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfec

27、tion as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. Keywords: disinfection, medical ins

28、truments, performance qualification, thermal disinfection, chemical disinfection, mechanical requirements, WD, water, cleaning efficacy, residual proteinaceous contamination AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those sub

29、stantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI s

30、tandards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date

31、of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are

32、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 for enforceme

33、nt of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyr

34、ight 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 federal law

35、(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 damages of $

36、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, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America I

37、SBN 1-57020-365-2 Contents Page Glossary of equivalent standards v Committee representation. vii Background of AAMI adoption of ISO 15883-1:2006 x U.S. Deviations to ISO 15883-1:2006. xi Foreword. xvii Introduction . xviii 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Performance

38、 requirements 9 4.1 General. 9 4.2 Cleaning . 10 4.3 Disinfection 11 4.4 Rinsing . 12 4.5 Drying. 13 4.6 Process chemicals 13 5 Mechanical and process requirements.14 5.1 Materials, design and manufacture/construction 14 5.2 Safety 15 5.3 Calorifiers and tanks. 15 5.4 Loading and unloading doors and

39、 their controls 16 5.5 Pipework and fittings 18 5.6 Spray systems. 19 5.7 Dosing systems. 20 5.8 Load temperature protection . 20 5.9 Process temperature control limits. 21 5.10 Switches, gauges and indicating devices 22 5.11 Process verification 22 5.12 Instrumentation and controls 23 5.13 Temperat

40、ure indicating systems. 24 5.14 Pressure indicating systems . 25 5.15 Timing equipment . 26 5.16 Operating cycle indicating equipment 26 5.17 Recording instruments (if fitted) . 26 5.18 Control systems 28 5.19 Override of automatic control 29 5.20 Microprocessor control systems 29 5.21 Access to sof

41、tware . 30 5.22 Fault indication systems 30 5.23 Water supply 31 5.24 Venting and drainage systems 31 5.25 Drainage. 32 5.26 Air filters installed within the WD 32 5.27 Load handling and supports for use within the WD 32 5.28 Trolleys 33 5.29 Environment 34 6 Testing for conformity 34 6.1 General. 3

42、4 6.2 Test equipment 37 6.3 Tests on doors, interlocks and fault indications . 38 6.4 Tests on water quality and water volume.41 6.5 Tests on pipework. 43 6.6 Tests on instrumentation fitted to the WD .45 6.7 Tests on load carriers. 46 6.8 Thermometric tests. 47 6.9 Chemical dosing tests 50 6.10 Tes

43、ts of cleaning efficacy 51 6.11 Tests of air quality 53 6.12 Load dryness test . 54 6.13 Automatic control test 54 7 Documentation 55 8 Information to be supplied by the manufacturer . 55 8.1 General. 55 8.2 Before delivery of the WD and for installation. 56 8.3 At delivery of the WD 57 9 Marking, l

44、abeling and packaging 58 9.1 Marking and labeling 58 9.2 Packaging 59 10 Information to be requested from the purchaser by the supplier of the WD 59 Annex A (informative) Test program 61 Annex B (informative) A0concept Comparative lethality of moist heat processes . 65 Annex C (normative) Test metho

45、ds for the detection and assessment of residual proteinaceous contamination 69 Annex D (normative) Microbiological recovery medium for estimation of bacterial contamination of water. 75 Annex E (informative) Re-qualification and routine testing. 76 Bibliography . 77 2009 Association for the Advancem

46、ent of Medical Instrumentation ANSI/AAMI ST15883-1:2009 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below

47、 gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be con

48、sidered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2009 ANSI/AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 M

49、ajor technical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-30:2009 ANSI/AAMI/IEC 80601-2-30:2009 Identical (with inclusion) IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR608