ANSI ST24-1999 Automatic general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities.pdf

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

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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

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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

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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

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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