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1、 Reference number ISO 18472:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 18472 First edition 2006-06-01 Sterilization of health care products Biological and chemical indicators Test equipment Strilisation des produits de sant Indicateurs biologiques et chimiques Appareillage dessai ISO 18472:2006(E)
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5、06 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the cou
6、ntry of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved ISO 18472:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Int
7、roduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Performance requirements for resistometers . 4 4.1 Intended use 4 4.2 Measurement and control capabilities . 4 4.3 Test methods. 4 4.4 Leak test 4 4.5 Steam resistometer performance requirements 4 4.6 Ethylene oxide resis
8、tometer performance requirements. 7 4.7 Dry heat (heated air) resistometer performance requirements . 9 4.8 Vaporized hydrogen peroxide process resistometer performance requirements. 11 5 Recording systems. 12 5.1 Measurement systems . 12 5.2 Calibration . 12 6 Documentation 12 6.1 General. 12 6.2 M
9、inimum information . 13 Annex A (informative) Additional performance characterization Steam . 14 Annex B (informative) Additional performance characterization Ethylene oxide. 17 Annex C (informative) Additional performance characterization Dry heat . 20 Annex D (informative) Resistometer documentati
10、on and derivations 22 Bibliography. 28 -,-,- ISO 18472:2006(E) iv ISO 2006 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carri
11、ed out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. I
12、SO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Internati
13、onal Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the el
14、ements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 18472 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This first edition of ISO 18472 partially replaces ISO 11140-
15、2. ISO 18472:2006(E) ISO 2006 All rights reserved v Introduction To test the performance of chemical and biological indicators, specific test equipment is required. This International Standard specifies the performance requirements for the test equipment to be used in order to establish the response
16、 of chemical and biological indicators to critical process variables. This International Standard does not apply to test equipment for irradiation indicators or low temperature steam and formaldehyde indicators. Resistometers constitute test equipment designed to create precise and repeatable steril
17、izing environments, allowing the evaluation of their effect on biological inactivation kinetics, chemical reactions, material degradation and product bioburden. Resistometers allow precise variation of the environmental conditions and cycle sequences in order to produce controlled physical studies.
18、When used with the defined test methods given in ISO 11138 for biological indicators and ISO 11140 for chemical indicators, the results of these studies can be used to demonstrate conformance of biological indicators and chemical indicators to these standards. Resistometers differ from conventional
19、sterilizers. Instrumentation selection and control requirements for resistometers are based upon mathematical models in which rates of reaction, measurement accuracy and process control requirements are evaluated to quantify the effects induced by test equipment-controlled variables. The requirement
20、s for accurate measurement, precise control, and rapid rates of change approach limits of commercially available process control and calibration instrumentation accuracy. The measurement and control requirements often prohibit practical validation of a resistometer using procedures that might be emp
21、loyed in a conventional heat or chemical sterilization system. Resistometers are considered test equipment rather than sterilizers; therefore, an understanding of instrumentation and process design is critical in clarifying requirements on precision and accuracy. Practical design has to consider the
22、 following: achievable measurement and control; acceptable equipment induced variation in test results; economic design (utilizing tight process controls only where required); test method correlation with intended use; historical knowledge applied to test procedures and an understanding of micro-env
23、ironmental physical phenomena; testing and analysis alternatives, when accurate quantitative determinations exceed physical measurement/control limits. -,-,- INTERNATIONAL STANDARD ISO 18472:2006(E) ISO 2006 All rights reserved 1 Sterilization of health care products Biological and chemical indicato
24、rs Test equipment 1 Scope 1.1 This International Standard specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chem
25、ical indicators, or the requirements given in the ISO 11138 series for biological indicators. This International Standard also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. ISO 111
26、38-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this International Standard, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 and ISO 11140. NOTE Resistometers for formaldehyde indicato
27、rs are not included in this International Standard. Test methods using laboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and ISO 11140-4. 1.2 This International Standard does not address the methods used to demonstrate compliance of biological or chemical indicator
28、s to ISO 11138 and ISO 11140, as these are covered in the appropriate parts of these standards. Indicators used with combination processes, such as washer-disinfection, are not covered by this International Standard. NOTE Test equipment and methods necessary for ISO 11140-3, ISO 11140-4 or ISO 11140
29、-5 are specified in those standards. 1.3 This International Standard does not address safety aspects of the test equipment because these are usually covered by specific regional, national or local regulations. 2 Normative references The following referenced documents are indispensable for the applic
30、ation of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11138-2, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene
31、oxide sterilization processes ISO 11138-3, Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes ISO 11138-4, Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilizatio
32、n processes ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General requirements ISO 18472:2006(E) 2 ISO 2006 All rights reserved ISO 11140-41), Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to Bowie and Dick tes
33、t for detection of steam penetration ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices IEC 60584 (all parts), Thermocouples IEC 60751:1983, Industrial platinum resistan
34、ce thermometer sensors 3 Terms and definitions For the purpose of this document, the terms and definitions given in ISO 11138, ISO 11140 and the following apply. 3.1 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process
35、ISO/TS 11139:2006, definition 2.3 3.2 calibration set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values r
36、ealized by standards VIM 1993, definition 6.11 3.3 chemical indicator non-biological indicator system that reveals change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process ISO/TS 11139:2006, definition 2.6 3.4 come-up period time
37、elapsed from the introduction of the sterilizing agent to the attainment of the minimum specified exposure conditions 3.5 come-down period time elapsed from the termination of the exposure period to an established null reaction point 3.6 exposure period time from the initial attainment of the minimu
38、m specified exposure conditions to the termination of the exposure period NOTE This phase of the cycle includes the stabilization period and the steady state period 1) To be published. (Revision of ISO 11140-4:2001) -,-,- ISO 18472:2006(E) ISO 2006 All rights reserved 3 3.7 measurement accuracy clos
39、eness of the agreement between the result of a measurement and the true value of the measurement NOTE 1 “Accuracy” is a qualitative concept. NOTE 2 The term “precision” should not be used for “accuracy”. 3.8 null reaction point terminating set of conditions that are either specified in the document
40、or have been established and demonstrated to produce no significant effect on the indicators 3.9 precision degree of reproducibility of a measurement 3.10 reference standard standard, generally having the highest metrological quality available at a given location or in a given organization, from whi
41、ch measurements are derived 3.11 resistometer test equipment designed to create defined combinations of the physical and/or chemical variables of a sterilization process NOTE Resistometers were formerly referred to as a Biological Indicator Evaluator Resistometer (BIER) or Chemical Indicator Evaluat
42、or Resistometer (CIER) test systems. 3.12 response time time required for a 90 % change in sensor output when exposed to a step change in the variable being measured NOTE It may be necessary to determine the sensor response time using a faster data sampling rate than the minimum for the equipment sp
43、ecified in this International Standard. Documentary evidence from the sensor manufacturers stated response time is equally acceptable as proof of conformance. 3.13 saturated steam water vapour in a state of equilibrium between condensation and evaporation 3.14 stabilization period elapsed time from
44、the attainment of the minimum specified exposure conditions until the end of the defined time to achieve steady state conditions 3.15 steady state period that portion of the exposure period which begins after the stabilization period and terminates at the end of the exposure period, during which tim
45、e all control parameters are within the specified limits -,-,- ISO 18472:2006(E) 4 ISO 2006 All rights reserved 4 Performance requirements for resistometers 4.1 Intended use The resistometer is intended to be used to expose test samples under stated test conditions, and therefore shall be capable of
46、 producing cycle sequences as required for specific test methods. Depending upon the test methods defined in ISO 11138-2, ISO 11138-3, ISO 11138-4 and ISO 11140-1, the resistometer utilized need only verify those limits necessary to characterize the chemical or biological indicators. NOTE The follow
47、ing specifications define the conditions to be achieved in the vessel in which the sample is to be placed, but the means by which these conditions are to be controlled are not addressed. 4.2 Measurement and control capabilities The following performance requirements define the measurement and contro
48、l capabilities for steam, ethylene oxide, dry heat, and vaporized hydrogen peroxide resistometers. 4.3 Test methods The equipment specified in this International Standard shall be used with the detailed test methods given in the appropriate parts of ISO 11138 and ISO 11140. NOTE The claimed performa
49、nce tolerances for chemical and biological indicators are based on the specified exposure conditions without allowance for the operational tolerances of the test equipment. 4.4 Leak test 4.4.1 With the temperature stabilized and the chamber empty (except for fixed furniture and necessary monitoring sensors) start the