1、July 2007DEUTSCHE NORM English price group 17No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.20!,yh%“9866902www
2、.din.deDDIN EN ISO 11140-4Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-typetest for detection of steam penetration (ISO 11140-4:2007)English version of DIN EN ISO 11140-4:2007-07Sterilisation von Produkten fr die Gesundh
3、eitsvorsorge Chemische Indikatoren Teil 4: Indikatoren der Klasse 2, die alternativ zum Bowie-Dick-Test fr den Nachweis derDampfdurchdringung verwendet werden (ISO 11140-4:2007)Englische Fassung DIN EN ISO 11140-4:2007-07SupersedesDIN EN 867-4:2001-02www.beuth.deDocument comprises 43 pages09.07DIN E
4、N ISO 11140-4:2007-07 2 National foreword This standard has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involve
5、d in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-04-08 AA Indikatoren. DIN EN ISO 11140 consists of the following parts under the general title Sterilization of health care products Chemical indicators1): Part 1: General requirements Part
6、 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration In addition, reference is made to DIN EN 867-5, Non-biological systems for use in sterilizers Part 5
7、: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers type B and type S, which is intended to be revised under the Vienna Agreement. The test method described by Bowie in 1963 is carried out throughout the world in many variations. T
8、o detect steam penetration within the context of ISO 17665-1, two variations are possible: the Bowie and Dick test as described in EN 285:2006 and the alternative test (“Bowie and Dick-type test”) specified in this part of DIN EN ISO 11140. The Bowie and Dick test as in EN 285:2006 requires the use
9、of a standard test pack or a reduced test pack with an indicator as in Part 3 of DIN EN ISO 11140. The alternative test described here gives the same results when carried out under the specified conditions. The DIN Standards corresponding to the International Standards referred to in clause 2 and in
10、 the bibliography of the EN are as follows: IEC 60584-2 DIN IEC 60584-2 IEC 60751 DIN IEC 60751 ISO 187 DIN EN 20187 ISO 2248 DIN EN 22248 ISO 9001 DIN EN ISO 9001 ISO 10012-1 DIN EN ISO 10012 ISO 11140-1 DIN EN ISO 11140-1 ISO 11140-3 DIN EN ISO 11140-3 ISO 15882 DIN EN ISO 15882 ISO 17665-1 DIN EN
11、 ISO 17665-1 1) ISO 11140-2:1998, Test equipment and methods, has been withdrawn and superseded by ISO 18472:2006, Sterilization of health care products Biological and chemical indicators Test equipment. ISO 11140-5:2000, Class 2 indicators for Bowie and Dick-type air removal tests, has not been ado
12、pted by CEN as a European Standard. DIN EN ISO 11140-4:2007-07 3 Amendments This standard differs from DIN EN 867-4:2001-02 as follows: a) In the scope, the indicator class designation has been harmonized with the new designation system specified in DIN EN ISO 11140-1. Thus, “Class B indicators” are
13、 now referred to as “Class 2 indicators”. b) Now only six temperature sensors are required, rather than twelve. c) In the description of air removal by trans-atmospheric pulsing, requirements for any air injection system used are no longer specified. d) An ultimate pressure of 5 kPa has been specifi
14、ed for the evacuation of the chamber of the steam exposure apparatus. e) In Annex C, an illuminant has been specified for the apparatus. f) Requirements for the air injection system have been modified. g) The standard has been editorially revised. Previous editions DIN EN 867-4: 2001-02 National Ann
15、ex NA (informative) Bibliography DIN EN 20187, Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples DIN EN 22248, Packaging Complete, filled transport packages Vertical impact test by dropping DIN EN ISO 9001,
16、 Quality management systems Requirements DIN EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General requirements DIN EN ISO 11140-3, Sterilization of hea
17、lth care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test DIN EN ISO 15882, Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results DIN EN ISO 17665-1, Sterilization of
18、 health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN IEC 60584-2, Thermocouples Part 2: Tolerances DIN IEC 60751, Industrial platinum resistance thermometer sensors DIN EN ISO 11140-4:2007-07 4 Th
19、is page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11140-4March 2007ICS 11.080.01 Supersedes EN 867-4:2000 English VersionSterilization of health care products - Chemical indicators - Part 4:type test for detection of steam penetration (ISO 11140-4:2007)Strilisation
20、 des produits de sant - Indicateurs chimiques -Partie 4: Indicateurs de Classe 2 comme alternative lessai de Bowie et Dick pour la dtection de la pntrationde la vapeur (ISO 11140-4:2007)Sterilisation von Produkten fr die Gesundheitsfrsorge -Chemische Indikatoren - Teil 4: Indikatoren der Klasse 2,di
21、e alternativ zum Bowie-Dick-Test fr den Nachweis derDampfdurchdringung verwendet werdenThis European Standard was approved by CEN on 14 March 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a
22、 national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version
23、in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
24、Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROP
25、ISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11140-4:2007: EClass 2 indicators as an alternative to the Bowie and Dick-(ISO 11140-4:2007)Cont
26、ents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 General requirements7 5 Indicator system format 8 6 Performance requirements .8 7 Packaging and labelling10 8 Quality assurance11 Annex A (normative) Determination of indicator strength during and aft
27、er steam sterilization 12 Annex B (normative) Standard test cycles.14 Annex C (normative) Estimation of visual difference between colour of the substrate and of the changed or unchanged indicator system by determination of relative reflectance density .19 Annex D (normative) Determination of uniform
28、 colour change on exposure to saturated steam .23 Annex E (normative) Determination of equivalence of the alternative indicator to the Bowie and Dick test 24 Annex F (normative) Determination of reproducibility of fail conditions created in a standard test pack by air injection, air leak and retaine
29、d air systems 26 Annex G (normative) Determination of indicator colour change on exposure to dry heat.30 Annex H (normative) Determination of shelf life of product.31 Annex I (normative) Accelerated ageing of test samples .32 Annex J (normative) Steam exposure apparatus and steam for test purposes.3
30、3 Annex K (normative) Standard test pack36 Annex L (normative) Air injection system 37 Bibliography 39 EN ISO 11140-4:2007 (E) 2 Foreword This document (EN ISO 11140-4:2007) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Co
31、mmittee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2007, and conflicting national standards s
32、hall be withdrawn at the latest by September 2007. This document supersedes EN 867-4:2000. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). The series EN ISO 11140
33、consists of the following parts under the general title Sterilization of health care products Chemical indicators: Part 1: General requirements Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test Part 4: Class 2 indicators as an alternative to the Bowie and Di
34、ck-type test for detection of steam penetration Attention is drawn to the fact that the series ISO 11140 additionally consists of Part 5: Class 2 indicators for Bowie and Dick-type air removal tests. However, this Part of ISO 11140 will not be part of the series EN ISO 11140 because CEN/TC 102 decid
35、ed not to adopt ISO 11140-5 as a European Standard. In addition, reference is made to EN 867-5 Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers type B and type S and to EN ISO
36、15882 Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results: Both standards are currently being revised under the Vienna Agreement (ISO/TC 198 lead). According to the CEN/CENELEC Internal Regulations, the national standards organizations
37、of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sl
38、ovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11140-4:2007 has been approved by CEN as EN ISO 11140-4:2007 without any modifications. EN ISO 11140-4:2007 (E) 3 Introduction The Bowie and Dick test is a performance test for steam sterilizers for w
39、rapped goods and porous loads. As such it is performed during the demonstration of conformance of steam sterilizers to EN 285 and as a routine test of performance in ISO 17665-1. The test method is described in EN 285. A failure of the Bowie and Dick test is symptomatic of a number of potential prob
40、lems with the sterilizer that could compromise the uniform sterilization of a load to be processed. This failure is not conclusive proof that the fault in the sterilizer is due to air retention, air leakage or non-condensable gases, and it can be necessary to investigate other causes of failure. The
41、 Bowie and Dick test was conceived as a test for successful air removal from high-vacuum porous-load sterilizers used in the sterilization of health care products 1. A successful Bowie and Dick test indicates rapid and even penetration of steam into the test pack. The presence of air within the pack
42、, due to an inefficient air removal stage, an air leak during this stage or non-condensable gases in the steam supply, are circumstances which can lead to failure of the test. The result of the test may also be affected by other factors which inhibit steam penetration. The test does not necessarily
43、demonstrate either achievement of the required temperature or maintenance of that temperature for the required time to achieve sterilization. A test pack for the Bowie and Dick test consists of two components: a) a small standardized test load; b) a chemical indicator system to detect the presence o
44、f steam. The Bowie and Dick test as originally described 1utilized huckaback towels as the material for the test load. The test as described in EN 285 uses cotton sheets for this purpose. Indicators intended as an alternative to the Bowie and Dick test use different materials for the test load and e
45、mploy indicator systems specifically formulated for use with the defined test load. Because a range of different tests in different countries have historically been termed the Bowie and Dick test, the term “Bowie and Dick-type test” is used in this part of ISO 11140.N1)This part of ISO 11140 specifi
46、es the performance of the indicator system in combination with the test load with which it is intended to be used. The test load may be presented with the indicator system already incorporated and intended for single use, or it may be intended for multiple use with a new indicator system to be inser
47、ted prior to each use. The indicator for which the performance is specified in this part of ISO 11140 is intended to indicate when steam penetration has been inadequate. The performance of the indicator specified in this part of ISO 11140 should be equivalent, but not necessarily identical, to the p
48、erformance obtained in the Bowie and Dick-type test as described in ISO 11140-3. Equivalence should be regarded as providing a similar response to steam penetration with any differences being predictable and such that the necessary level of assurance of satisfactory steam penetration is provided. An
49、 indicator meeting this specification is not intended to identify which of the potential causes of poor steam penetration was responsible for the failure indicated by the test. N1) National footnote: To distinguish between the alternative methods described in this part of the DIN EN ISO 11140 series, the term “Bowie-Dick-Test” refers to the test using an indicator sheet in a test pack as in Part 3 of the series. Applies to German language version only. EN ISO 11140-4:2007 (E) 4 1 Scope This part of
