1、ANSI/AAMI ST24:1999/(R)2013Automatic, general purposeethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities American National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and poten
2、tial 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 instrumentation. Essential to such advancement are (1) a continued increase in the safe and effect
3、ive 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 advancement of medical instrumentation, provided that they are drafted with attention to these objecti
4、ves and provided that arbitrary 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 clin
5、ical use, and the measurement 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, inclu
6、ding performance characteristics, 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 spe
7、cialized test methods to 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
8、provided and the reasons 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 prac
9、tices that will help ensure 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 eval
10、uation. Similarly, even 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 c
11、riteria, provide guidelines 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
12、 industrial practices. 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
13、 by government regulatory 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 ca
14、re professionals and industrial 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
15、standard or recommended 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 rep
16、lace responsible decision-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 d
17、eveloped and the specific 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
18、 current procedures and 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 wi
19、ll serve to identify a 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
20、should be analyzed in the 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 p
21、ractice is truly useful 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 pra
22、ctices must be made in 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 represe
23、ntation of the Association 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 st
24、andard 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 News. American National Standard ANSI/AAMI ST24:1999/(R)2013(Revision of ANSI/AAMI ST24:1992)Aut
25、omatic, general-purpose ethylene oxidesterilizers and ethylene oxide sterilant sourcesintended for use in health care facilitiesDeveloped byAssociation for the Advancement of Medical InstrumentationApproved 27 May 1999 and reaffirmed 26 November 2013 byAmerican National Standards Institute, Inc.Abst
26、ract: This standard covers minimum labeling, safety, performance, and testing requirements forethylene oxide sterilizers that are intended for general-purpose use in health care facilities andthat have automatic controls. It also covers labeling, product composition, and containerrequirements for et
27、hylene oxide sterilant sources, as well as labeling, performance, safety, andinstallation requirements for ethylene oxide emission control systems.Keywords: ethylene oxide sterilization, ethylene oxide emission controlAAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI
28、) standard implies a consensus of thosesubstantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respectpreclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or usingproducts, processes, or procedure
29、s not conforming to the standard. AAMI standards are subject to periodic review, andusers are cautioned to obtain the latest editions.CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that actionbe taken to reaffirm, revise, or withdraw this standard
30、 no later than 5 years from the date of publication. Interestedparties may obtain current information on all AAMI standards by calling or writing AAMI.Published byAssociation for the Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-5762 2000 by the Association f
31、or the Advancement of Medical InstrumentationAll Rights ReservedThis publication is subject to copyright claims of AAMI. No part of this publication may be reproduced or distributed in anyform, including an electronic retrieval system, without the prior written permission of AAMI. All requests perta
32、ining to thisdraft should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any partof this document (whether internally or externally) without the prior written permission of the Association for theAdvancement of Medical Instrumentation. Violato
33、rs risk legal action, including civil and criminal penalties, and damagesof $100,000 per offense. For permission regarding the use of all or any part of this document, contact Kurt C. Larrick,Director, Technical Publishing, at AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 52
34、5-4890,Ext. 239; Fax: (703) 525-1067.Printed in the United States of AmericaISBN 1-57020-119-6ContentsPageCommittee representation. vAcknowledgmentviiForeword .viii1 Scope. 11.1 General 11.2 Inclusions 11.3 Exclusions . 12 Normative references. 13 Definitions, symbols, and abbreviations. 24 Requirem
35、ents. 34.1 Requirements for EO sterilizers. 34.1.1 Labeling. 34.1.2 Sterilizer construction, components, and accessories 44.1.3 Sterilizer safety 44.1.4 Process monitoring devices 54.1.5 Physical performance of sterilizers . 54.1.6 Biological performance of sterilizers . 54.1.7 Certification and rec
36、ordkeeping 54.2 Requirements for EO sterilant sources 54.2.1 Registration. 54.2.2 Labeling. 64.2.3 Container safety 64.2.4 Product composition 64.2.5 Shipping 64.3 Requirements for EO emission control systems 64.3.1 System approvals 64.3.2 Labeling. 64.3.3 Performance requirements 74.3.4 Safety requ
37、irements 74.3.5 Installation requirements. 75 Tests 7AnnexesA Rationale for the development and provisions of this standard . 11B Calculating chamber relative humidity . 15C Calculating chamber ethylene oxide concentration17D Bibliography 21Tables1 Test pack number and location for empty-chamber tes
38、ting . 92 Number of test packs for simulated-load testing 9B.1 Temperature versus saturation pressure of water vapor 15C.1 EO/diluent constants and molecular weights 18C.2 Gas constants (R = PV/nt) 18FigureB.1 Relative humidity versus partial pressure for two common sterilization temperatures. 16 19
39、99 Association for the Advancement of Medical Instrumentation onesansinv ANSI/AAMI ST24:1999 vCommittee representationAssociation for the Advancement of Medical InstrumentationSterilization Standards CommitteeThis standard was developed by the AAMI Hospital EO Sterilizer Working Group under the ausp
40、ices of the AAMISterilization Standards Committee. Committee approval of the standard does not necessarily mean that allcommittee and working group members voted for its approval.The AAMI Sterilization Standards Committee has the following members:Cochairs: Virginia C. Chamberlain, PhDWilliam E. You
41、ngMembers: Carl W. Bruch, PhD, Consultant, Hudson, WIVirginia C. Chamberlain, PhD, VC Chamberlain and Associates, Hendersonville, NCNeal E. Danielson, Ds Enterprise, Wichita, KSJudith Dowler, Medical Devices Bureau, Health Canada, Ottawa, ONFrank B. Engley, Jr., PhD, University of Missouri, Columbia
42、, MOVictoria Hitchins, PhD, U.S. Food and Drug AdministrationRobert Morrissey, PhD, Johnson “should” indicates that among several possibilities one is recommended as particularly suitable,without mentioning or excluding others, or that a certain course of action is preferred but not necessarily requ
43、ired, orthat (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” isused to indicate that a course of action is permissible within the limits of the standard; and “can” is used as astatement of possibility and capability. “Must” is used only
44、 to describe “unavoidable” situations, including thosemandated by government regulation.This standard should be considered flexible and dynamic. As technology advances and as new data are broughtforward, the standard will be reviewed and, if necessary, revised.Suggestions for improving this standard
45、 are invited. Comments and suggested revisions should be sent to TechnicalPrograms, AAMI, 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598.NOTEThis foreword does not contain provisions of the American National Standard, Automatic, general-purposeethylene oxide sterilizers and ethylene
46、oxide sterilant sources intended for use in health care facilities (ANSI/AAMIST24:1999), but it does provide important information about the development and intended use of the document. 1999 Association for the Advancement of Medical Instrumentation onesansinv ANSI/AAMI ST24:1999 1American National
47、 Standard ANSI/AAMI ST24:1999/(R)2013Automatic, general-purpose ethylene oxidesterilizers and ethylene oxide sterilant sourcesintended for use in health care facilities1 Scope1.1 GeneralThis standard applies to automatic, general-purpose ethylene oxide (EO) sterilizers and EO sterilant sources that
48、areintended for use in hospitals and other health care facilities.NOTEFor purposes of this standard, “health care facilities” means hospitals, nursing homes, extended-care facilities,freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term “hospital” is somet
49、imes used inthis recommended practice; in all instances, this term should be taken to encompass all other health care facilities.1.2 InclusionsThis standard covers minimum labeling, safety, performance, and testing requirements for EO sterilizers that areintended for general-purpose use in health care facilities and that have automatic controls. For purposes of thisstandard, a “general-purpose” EO sterilizer is defined as a chamber-type sterilization system that injects water vaporto adjust humidity during the cycle, generally employs excursions in pressure from a
