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15、 2012 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caPLUS 1173Guide to the selection and use of sterilization indicatorsCSA Standard100%ISBN
16、 978-1-55491-820-1 Canadian Standards Association 2012All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher.To purchase CSA Standards and related publications, visit CSAs Online Store at shop.csa.ca or call toll-free 1
17、-800-463-6727 or 416-747-4044.The Canadian Standards Association (CSA) prints its publications on Rolland Enviro100, which contains 100%recycled post-consumer fibre, is EcoLogo and Processed Chlorine Free certified, and was manufactured using biogas energy.January 2012 iiiContents Canadian Standards
18、 Association Guide to the selection and use of sterilization indicatorsPreface v1 Effective sterilization processing 11.1 Introduction 11.2 Cornerstone of sterilization process monitoring 11.3 Rapid sterilization indicators 12 Assessing sterilization effectiveness 23 Determining the efficacy of a st
19、erilization process 43.1 Available information 43.2 False readings 43.3 Sterilization indicators 43.3.1 Physical monitors 43.3.2 Chemical indicators 53.3.3 Biological indicators 83.3.4 Process challenge devices 104 Selecting a new sterilization indicator system 114.1 Comparison systems 114.2 Conside
20、rations 114.3 Equivalency 114.4 Labelling differences 125 Managing risk 155.1 Overview 155.2 Three elements 155.3 Risk assessment 156 Evaluating the system 156.1 In use testing 157 Additional considerations 168 Sensitivity of sterilization indicators 179 Sterilization failures 1810 Summary 1911 Refe
21、rences 19AnnexesA Verification and validation testing 21B Implementing a new system 30C Sterilization failures Factors to consider 34D Reference publications 37Tables1 Comparison of moist heat biological indicator characteristics to ISO 11138-3 14PLUS 1173 Canadian Standards Associationiv January 20
22、12Figures1 Semi-logarithmic plot of the inactivation of microorganisms versus sterilization exposure time 32 Example of a sterilizer display panel indicating time, temperature, and pressure 53 Example of a Class 1 process indicator 64 Example of a Class 2 indicator (Bowie-Dick test) showing a failed
23、 air removal test 75 Example of a Class 5 process indicator 86 Example of a self-contained biological indicator 97 Example of a self-contained rapid readout biological indicator system 108 Example of a process challenge device 10 Canadian Standards Association Guide to the selection and use of steri
24、lization indicatorsJanuary 2012 vPrefaceThis is the first edition of CSA PLUS 1173, Guide to the selection and use of sterilization indicators. This handbook has been developed to answer general questions in all health care and personal service settings where monitoring of the effectiveness of repro
25、cessing of medical devices takes place.CSA gratefully acknowledges the valuable work of Patrick McCormick, the author of this document. Dr.McCormick has been a member of the CSA Technical Committee on Sterilization since 1995 and of the AAMI Sterilization Standards Committee since 2002.CSA also grat
26、efully acknowledges the contributions of Anne-Marie Rancourt, Colleen Landers, Dianne Trudeau, Gale Schultz, Joan Thompson, Laurie Buist, Lorna Coutoulas, Linda Jakeman, Linda Kingsbury, Merlee Steele-Rodway, Pat Piaskowski, Patrick Quinn, Rupinder Khotar, Sue Lafferty, Susan Hadfield, Tim Richardso
27、n, and Michelle Alfa as peer reviewers of this manuscript.This Guide complements the CSA Z314 series of Standards, which sets out requirements for medical device cleaning, decontamination, and sterilization in health care facilities. January 2012Notes: (1) Use of the singular does not exclude the pl
28、ural (and vice versa) when the sense allows.(2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.(3) This publication was de
29、veloped by consensus, which is defined by CSA Policy governing standardization Code of good practice for standardization as “substantial agreement. Consensus implies much more than a simple majority, but not necessarily unanimity”. It is consistent with this definition that a member may be included
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33、gestions for their improvement will be referred to the appropriate committee. To submit a proposal for change to CSA Standards, please send the following information to inquiriescsa.ca and include “Proposal for change” in the subject line:(a) Standard designation (number);(b) relevant clause, table,
34、 and/or figure number;(c) wording of the proposed change; and(d) rationale for the change. Canadian Standards Association Guide to the selection and use of sterilization indicatorsJanuary 2012 1PLUS 1173Guide to the selection and use of sterilization indicators1 Effective sterilization processing1.1
35、 IntroductionEffective sterilization processing is critical to the successful outcome of the thousands of sterile procedures that are performed daily at health care institutions and clinics throughout North America. This requires that reusable surgical instruments and medical devices be effectively
36、cleaned, inspected, packaged, labelled, sterilized, and transported for reprocessing following their use. Multiple steps are necessary to ensure that each patient receives instruments and supplies that have been processed to the highest standards of care. In order to ensure the delivery of instrumen
37、tation that is safe and effective for use, health care professionals should not only adhere to the recommendations of the instrument manufacturer and relevant processing guidelines, but need to also have an understanding of the technology (equipment and processes) used to reprocess surgical instrume
38、nts and medical devices. This includes an understanding of the basis whereby a given sterilization load is deemed acceptable for use. A key factor in this determination is the results of testing performed with various types of sterilization indicators.1.2 Cornerstone of sterilization process monitor
39、ingThe use of a combination of physical monitors and chemical and biological sterilization indicators to monitor the efficacy of a sterilization process has formed the cornerstone of sterilization process monitoring for many years. Physical monitors and chemical indicators generally provide the user
40、 with an immediate response, whereas biological indicators (BI) can require a period of incubation ranging from 24 to 48 h following sterilization processing before reliable results are available. As sterilization loads are frequently released to distribution before the results of biological indicat
41、or testing are known, the user has to often rely on the results of testing with chemical indicators and information from physical monitors to provide an initial assessment of the adequacy of the sterilization process.1.3 Rapid sterilization indicatorsTo address the prolonged incubation time required
42、 by traditional biological indicators, sterilization indicators have been developed to provide the user with information that is claimed by the manufacturer of the indicator to be equivalent to that provided by a traditional biological indicator either shortly thereafter or immediately following ste
43、rilization processing. This technology includes rapid readout biological sterilization indicator systems that provide results within 90 min to 4 h of sterilization processing, and Class 5 and Class 6 chemical indicator systems whose performance is claimed to correlate to that of a biological indicat
44、or (Class 5) or respond to all critical variables for a given sterilization process (Class 6).This Guide is intended to supplement the information provided in existing sterilization indicator standards to assist the health care professional in making informed choices regarding the role, capabilities
45、, selection, and application of sterilization indicator systems, including the newer technology sterilization indicator systems. This Guide is not intended to establish requirements regarding the qualification of sterilization indicators or their use.PLUS 1173 Canadian Standards Association2 January
46、 20122 Assessing sterilization effectiveness2.1Sterilization may be defined as “a validated process used to render a product free from viable microorganisms” (1). Although sterilization is defined in absolute terms (an item is either sterile or non-sterile), it is in fact a function of probability.
47、As the probability of the presence of a viable microorganism can never be reduced to zero, we speak in terms of a Sterility Assurance Level (SAL) in describing the efficacy of a particular sterilization process. This concept is illustrated in Figure1, where it can be seen that extending the steriliz
48、ation processing time (or dose) results in increasing levels of microbial inactivation. This, in a sense, is the dichotomy of sterilization in that by definition we are attempting to assign an absolute outcome to a process (i.e., the items in sterilizer load are either sterile or non-sterile) when t
49、hat process is based on probability.Note: The numbered references in parentheses correspond with the references listed in Clause11.2.2The minimum acceptable SAL recognized by most health care authorities is 106 or a one-in-a-million probability of a surviving microorganism following processing. It should be noted that for the relationship described in Figure1, a linear correlation or relationship needs to exist between the rate of inactivation of microorganisms and the sterilization exposure time or dose. This correlation is central to sterilization
