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1、Technical Information Report AAMI TIR29:2002 AAMI Association for the Advancement of Medical Instrumentation Guide for process control in radiation sterilization www.aami.org Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Emp
2、loyees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:46 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical Information ReportAAMI TIR29:2002 Guide for process control in radiation sterilization Approved 16 July 2002 by Association for the Advanc
3、ement of Medical Instrumentation Abstract:This technical information report provides additional guidance for establishing and meeting the irradiator dose mapping, process qualification, and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137 for gamma and elect
4、ron beam sterilization. Although bremsstrahlung irradiation has similar requirements, there is little experience in the design and operation of a bremsstrahlung irradiation facility at the time of this work was initiated, and therefore the requirements for bremsstrahlung irradiation are not included
5、 in the scope. Keywords:irradiator dose mapping, process qualification, routine processing, irradiator validation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/20
6、07 02:52:46 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of
7、 medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should under
8、stand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards
9、, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically rev
10、iewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whet
11、her the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recomme
12、nded practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or techno
13、logy, readers are cautioned to ensure that they also have considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely wi
14、thin 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 enforcement of its rules and regulations. Comments on
15、this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2002 by the As
16、sociation for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Inst
17、rumentation is strictly prohibited by law. It is illegal under 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
18、risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the Un
19、ited States of America ISBN 1570201773 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:46 MDTNo reproduction or networking permitted without license from
20、 IHS -,-,- Contents Page Committee representationv Introduction. viii 1Scope1 2Normative reference .1 3Terms and definitions .1 4Installation qualification: Irradiator dose mapping.2 4.1General2 4.2Gamma2 4.2.1Homogeneous dose maps.2 4.2.2Additional dose map studies3 4.2.3Additional tests 4 4.2.4Rev
21、iew and analysis of data4 4.3Electron beam5 4.3.1Homogeneous dose maps.5 4.3.2Additional dose map studies6 4.3.3Additional tests 7 4.3.4Review and analysis of data7 5Process qualification.7 5.1General7 5.2Gamma8 5.2.1Product loading pattern .8 5.2.2Product dose mapping.8 5.2.3Review and analysis of
22、data9 5.2.4Selection of routine monitoring positions.9 5.2.5Documentation requirements 9 5.3Electron beam10 5.3.1Product loading pattern .10 5.3.2Product dose mapping.10 5.3.3Review and analysis of data11 5.3.4Selection of routine monitoring position.11 5.3.5Documentation requirements 11 6Routine mo
23、nitoring and control.12 6.1General12 6.2Receipt of product12 6.3Scheduling of gamma irradiators.12 6.3.1Irradiator characteristics 12 6.3.2Product specifications12 6.3.3Scheduling of single product runs .13 6.3.4Scheduling of multiple product runs 13 6.4Scheduling of electron beam irradiators 14 6.5
24、Loading of product.14 6.6Processing of product14 6.6.1Introduction14 6.6.2Gamma14 6.6.3Electron beam .15 6.7Unloading of product16 6.8Release of product.16 6.9Shipment of product.16 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=
25、IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:46 MDTNo reproduction or networking permitted without license from IHS -,-,- 7Mathematical modeling.16 7.1General16 7.2Types of models.17 7.2.1Introduction17 7.2.2Point Kernel method17 7.2.3Monte Carlo method17 7.3Use of mo
26、dels17 7.3.1Design of irradiators 17 7.3.2Operation of gamma irradiators.17 7.3.3Operation of electron beam irradiators18 8Routine evaluation of process quality.18 8.1General18 8.2Collection and review of data.18 9Maintenance of process effectiveness19 9.1General19 9.2Calibration19 9.3Irradiator req
27、ualification .19 9.3.1Introduction19 9.3.2Requalification documentation requirements 19 9.4Preventive maintenance and irradiator change control21 9.4.1Preventive maintenance21 9.4.2Irradiator change control22 Annexes AMeasurement uncertainty in routine monitoring of dose.23 BBibliography28 Tables 1G
28、amma irradiator requalification requirements.20 2Electron beam irradiator requalification requirements21 A.1 Dose map dataProcedure 1 24 A.2 Dose map dataProcedure 2 25 A.3 Adjustment factors for minimum and maximum dose.26 A.4 Adjustment factors for maximum dose .27 Figures 1Qualification grid dime
29、nsions5 2Ratio of measured dose vs. expected dose19 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:46 MDTNo reproduction or networking permitted without
30、 license from IHS -,-,- 2002 Association for the Advancement of Medical Instrumentation ! AAMI TIR29:2002v Committee representation Association for the Advancement of Medical Instrumentation AAMI Sterilization Standards Committee This technical information report was developed by the AAMI Radiation
31、Sterilization Working Group under the auspices of the AAMI Sterilization Standards Committee. Committee approval of the TIR does not necessarily imply that all committee members and working group members voted for its approval. At the time this document was published, the AAMI Sterilization Standard
32、s Committee had the following members: Cochairs:Victoria Hitchins, PhD William E. Young Members:Trabue D. Bryans, AppTec Laboratory Services Virginia C. Chamberlain, PhD, Hendersonville, NC Anne M. Cofiell, IAHCSMM Loretta L. Fauerbach, Association for Professionals in Infection Control and Epidemio
33、logy Dorothy M. Fogg, Association of periOperative Registered Nurses Lisa Foster, Ion Beam Applications James M. Gibson, Jr., JM Gibson Associates Barbara J. Goodman, Baltimore, MD Joel R. Gorski, PhD, North American Science Associates Susan Hadfield, Canadian Standards Association Deborah A. Havlik
34、, Abbott Laboratories Victoria Hitchins, PhD, FDA/CDRH Clark W. Houghtling, Cosmed Group, Inc. Lois Atkinson Jones, MS, Cary, NC Sue Kuhnert, Sterilization Technical Services Byron J. Lambert, PhD, Guidant Corporation Sandra A. Lee, STERIS Corporation Patrick J. McCormick, PhD, Bausch b)determining
35、the qualification dose map grid; c)performing additional dose map studies that examine the effects of transitions between different product runs, transit dose, partial loads, and center loading; d)scaling of dose; and e)reviewing and analyzing data. For electron beam, this is carried out by: a)perfo
36、rming homogeneous dose map studies; b)determining the qualification dose map grid; c)defining the beam characteristics through scan width uniformity and beam depth dose studies; d)performing additional dose map studies that examine edge effects, partial loads, process interruption, and number of pas
37、ses in front of the beam; e)scaling of dose; and f)reviewing and analyzing data. 4.2Gamma 4.2.1Homogeneous dose maps To characterize the irradiator with respect to the magnitude, distribution, and reproducibility of dose delivery, dose map studies using homogeneous material, in sufficient quantities
38、 to simulate a full irradiator, are performed. The homogeneous dose mapping studies should be performed for each product path to be used for routine processing. 4.2.1.1Determination of the qualification grid Dosimeters should be placed in a three-dimensional array sufficient to determine the minimum
39、 and maximum dose and to obtain knowledge of the dose distribution. The number of dosimeters and their distribution depends on the spatial resolution desired. Knowledge of the expected dose distribution obtained from mathematical modeling and/or dosimetry data from similar irradiator designs may be
40、used as a guide for selection of the grid. Other considerations in selection of the grid include system design and the range of processing parameters. 4.2.1.2Selection of materials Dose mapping should be carried out with homogeneous materials that are within the limits of the bulk density range for
41、which the irradiator is to be used. Typically, densities representing the minimum, maximum and, if applicable, an intermediate density, are examined. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=W
42、ing, Bernie Not for Resale, 03/21/2007 02:52:46 MDTNo reproduction or networking permitted without license from IHS -,-,- 2002 Association for the Advancement of Medical Instrumentation ! AAMI TIR29:20023 Some materials commonly used for the dose mapping studies include styrofoam sheets (approximate
43、ly 0.01 g/cm3 0.03 g/cm3), corrugated sheets (0.13 g/cm3 0.19 g/cm3), ceiling tiles (0.25 g/cm3 0.27 g/cm3), and soft plywood (0.40 g/cm3 0.60 g/cm3). It may be advantageous to use product for the irradiator dose mapping. The materials selected for the dose mapping studies should allow placement of
44、dosimeters throughout the dose-mapped volume within the irradiation container. 4.2.1.3Loading the irradiation container Irradiation containers used for homogeneous dose mapping studies should be filled to their design capacity. Weight limits for the irradiation container need to be taken into accoun
45、t when determining container fill for the homogeneous studies. While carrying out the homogeneous study, sufficient irradiation containers should be filled with the homogeneous material to simulate a fully loaded system. Often this can be accomplished by filling the irradiation containers where the
46、majority of dose is delivered (e.g., the product path directly adjacent to the source racks). The number of filled irradiation containers depends on the product path. 4.2.1.4Dosimetry Dosimeters should be placed in the irradiation containers in the positions defined by the qualification dose map gri
47、d. The dosimeters should be located in the irradiation containers that are surrounded by the homogeneous material (i.e., center portion of the irradiation run). To allow statistical analysis of the data and to test for reproducibility in the dose map data, a minimum of three containers should be dos
48、e mapped for each density studied. 4.2.1.5Processing conditions The homogenous dose map studies should be performed without source interruption, cycle time changes, or other interruptions during irradiation. All unusual events should be documented and investigated. If any event is cause for invalida
49、tion, the entire study or portion affected should be repeated. 4.2.1.6Analysis of data Statistical analysis of the resulting homogeneous dose map data should be performed to determine the equivalent zones of minimum and maximum dose, as well as those zones that are intermediate in dose. This information is used to se