1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Part 5: Class 2 indicators for Bowie and Dick-type air removal testsICS 11.080.01Sterilization of h
2、ealth care products Chemical indicators BRITISH STANDARDBS ISO 11140-5:2007BS ISO 11140-5:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2007ISBN 978 0 580 50705 2Amendments issued since publicationAmd. No. Date Commentsc
3、ontract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations. National forewordThis British Standard was published by BSI. It is the UK implementation of ISO 11140-5:2007.The UK participation in its preparation was entrus
4、ted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a Reference numberISO 11140-5:2007(E)INTERNATIONA
5、L STANDARD ISO11140-5Second edition2007-03-15Sterilization of health care products Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests Strilisation des produits de sant Indicateurs chimiques Partie 5: Indicateurs de Classe 2 pour lessai de Bowie et Dick denlvemen
6、t dair BS ISO 11140-5:2007ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 2 5 Indicator system . 2 5.1 Format 2 5.2 Performance 2 6 Indicator. 3 6.1 Format 3 6.2 Performance 3 7 Packaging and labelling. 4 8 Qual
7、ity assurance. 4 9 Sampling conditioning . 4 Annex A (normative) Determination of the degree of contrast between the colour of the substrate and the indicator agent 5 Annex B (normative) Method of determining uniform colour change on exposure to saturated steam 6 Annex C (normative) Method for deter
8、mining indicator colour change on exposure to dry heat. 7 Annex D (normative) Method for determining transfer of indicator agent to standard test pack . 8 Annex E (normative) Standard test pack. 9 Annex F (normative) Method of determining non-uniform colour change on exposure to a standard fault con
9、dition. 10 Annex G (normative) Steam exposure apparatus. 11 Bibliography . 12 BS ISO 11140-5:2007iv 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
10、carried 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 wo
11、rk. ISO 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 Inte
12、rnational 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 t
13、he elements 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 11140-5 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edi
14、tion (ISO 11140-5:2000), which has been technically revised. ISO 11140 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 penetrati
15、on test Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration Part 5: Class 2 indicators for Bowie and Dick-type air removal tests BS ISO 11140-5:2007vIntroduction The air removal test is used to evaluate the efficacy of air removal during th
16、e pre-vacuum phase of a pre-vacuum sterilization cycle or during the pulsing stage of positive pulsing cycles if non-condensable gases were present in the steam. Retention of air due to an inefficient air removal stage or the presence of an air leak or non-condensable gases during the air removal st
17、age are circumstances which can lead to failure of the test. This part of ISO 11140 describes the requirements for Class 2 indicators for Bowie and Dick-type air removal test sheets and packs. For a description of the classes of chemical indicators, see ISO 11140-1. The difference between the steam
18、penetration test (ISO 11140-3 and ISO 11140-4) and the air removal test (ISO 11140-5) is described in the chemical indicator guidance document (ISO 15882). BS ISO 11140-5:2007blank1Sterilization of health care products Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air remova
19、l tests 1 Scope This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, this part of ISO 11140 includes tes
20、t methods and equipment used to meet these performance requirements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced do
21、cument (including any amendments) applies. ISO 5-4:1995, Photography Density measurements Part 4: Geometric conditions for reflection density ISO 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 11140-1:2005, Sterilization of health care products Chem
22、ical indicators Part 1: General requirements IEC 60584-2:1982, Thermocouples. Part 2: Tolerances IEC 60751:1983, Industrial platinum resistance thermometer sensors 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11140-1 and the following apply. 3.1 i
23、ndicator system combination of the indicator agent and its substrate subsequently intended to be used in combination with a specific test load NOTE For the purposes of this document, the specific test load is the standard test pack as defined in Annex E. 3.2 indicator combination of the indicator ag
24、ent and its substrate in the final form in which it is intended to be used See Annex E of ISO 11140-1:2005. NOTE The indicator may be user-assembled or pre-assembled. The test load may be disposable, for limited re-use or re-usable. BS ISO 11140-5:20072 3.3 equilibration time period which elapses be
25、tween the attainment of the sterilization temperature in the sterilizer chamber and the attainment of the sterilization temperature in all parts of the load 4 General requirements Unless otherwise specified in this part of ISO 11140, the general requirements given in ISO 11140-1 apply. 5 Indicator s
26、ystem 5.1 Format 5.1.1 The indicator agent shall be uniformly distributed on its substrate to cover not less than 30 % of one side of the substrate. The pattern of indicator agent distribution should allow easy judgement of the uniformity of the colour change. 5.1.2 The substrate of the indicator sy
27、stem shall have a uniform ground colour which provides a difference in colour density of not less than 0,3 between ground colour and either the changed or the unchanged indicator agent, as specified by the manufacturer, when the difference in colour density is determined using a reflective densitome
28、ter. Compliance shall be tested in accordance with Annex A. 5.1.3 The indicator system dimensions shall be (200 20) mm (275 25) mm. 5.1.4 The indicator system shall have an air porosity not less than 1,7 m/(Pas) when tested in accordance with ISO 5636-3 at an air pressure of 1,47 kPa. 5.2 Performanc
29、e 5.2.1 The indicator system shall show a uniform colour change (as specified by the manufacturer) after exposure to saturated steam at 134 C for 3,5 min 5 s and/or exposure to saturated steam at 121 C for 15 min 5 s, or such other combinations of time and temperature as the manufacturer shall speci
30、fy for the intended use of product. In all cases, the permitted tolerance on the test temperature shall be 1,50+C and the time given shall be the time within which the colour change shall occur. Compliance shall be tested in accordance with Annex B. 5.2.2 When placed in the centre of the standard te
31、st pack as specified in Annex E, the indicator system shall show a non-uniform colour change when the temperature at the centre of the standard test pack is (210+)C lower than the temperature of the chamber drain at the beginning of the final 1 min of a 3,5 min cycle at 134 C, or at the beginning of
32、 the final 5 min of a 15 min cycle at 121 C of the exposure phase of the steam exposure apparatus. This is the standard fault condition generated by inadequate air removal from the chamber. Any other combination of time and temperature stated by the manufacturer shall exhibit a similar response at t
33、he beginning of the final 30 % of the exposure time. Compliance shall be tested in accordance with Annex F. 5.2.3 After exposure to dry heat at (140 2) C for not less than 30 min, the indicator agent shall show either no change or a change that is markedly different from the change occurring after e
34、xposure to a steam sterilization process. Compliance shall be tested in accordance with Annex C. BS ISO 11140-5:200735.2.4 Transfer of the indicator agent to the material of the standard test pack in which it is intended to be used shall not compromise the result of the test. Compliance shall be tes
35、ted in accordance with Annex D. NOTE Although some transfer can be possible without adversely affecting the performance of the indicator system or test pack, there are currently no test methods available to verify the acceptable limits of indicator agent transfer. 5.2.5 The indicator system shall co
36、mply with the requirements of this part of ISO 11140 for the duration of the shelf life specified by the manufacturer. A documented accelerated ageing procedure may be used in demonstrating compliance. 6 Indicator 6.1 Format 6.1.1 The indicator agent shall be uniformly distributed on its substrate t
37、o cover not less than 30 % of the test area of the substrate. 6.1.2 The substrate of the indicator system shall have a uniform ground colour which provides a difference in colour density of not less than 0,3 between ground colour and either the changed or the unchanged indicator agent, as specified
38、by the manufacturer, when the difference in colour density is determined using a reflective densitometer. Compliance shall be tested in accordance with Annex A. 6.2 Performance 6.2.1 The indicator system shall show a uniform colour change complying with 6.1.2 both after exposure to saturated steam a
39、t (1341,50+) C for 3,5 min 5 s and/or exposure to saturated steam at (1211,50+) C for 15 min 5 s, or such other combinations of time and temperature as the manufacturer shall specify for the intended use of product. In all cases, the permitted tolerance on the test temperature shall be1,50+C and the
40、 time given shall be the time within which the colour change shall occur. Compliance shall be tested in accordance with Annex B. 6.2.2 After exposure to conditions used to produce a standard fault condition (see 5.2.2) in the standard test pack as specified in Annex E, the indicator system shall sho
41、w a non-uniform colour change. Compliance shall be tested in accordance with Annex F. 6.2.3 After exposure to dry heat at (140 2) C for not less than 30 min, the indicator agent shall show either no change or a change that is markedly different from the change occurring after exposure to a steam ste
42、rilization process. Compliance shall be tested in accordance with Annex C. 6.2.4 Transfer of the indicator agent to the test load shall not compromise the result of the test. 6.2.5 The indicator shall comply with the requirements of this part of ISO 11140 for the duration of the shelf life specified
43、 by the manufacturer. A documented accelerated ageing procedure may be used in demonstrating compliance. BS ISO 11140-5:20074 7 Packaging and labelling 7.1 The general requirements in ISO 11140-1 apply. 7.2 In addition, each indicator, indicator system and its packaging shall be clearly marked with
44、the following. AIR REMOVAL8 Quality assurance The general requirements in ISO 11140-1 apply. 9 Sampling conditioning Test samples shall be conditioned for at least 1 h immediately prior to testing in an environment between (23 7) C with a relative humidity of 30 % to 70 %. BS ISO 11140-5:20075Annex
45、A (normative) Determination of the degree of contrast between the colour of the substrate and the indicator agent A.1 Apparatus A.1.1 Steam exposure apparatus, as specified in Annex G. A.1.2 Reflective densitometer, as specified in ISO 5-4, which has been calibrated and the calibration traceable to
46、a national standard. A.1.3 Standard test pack, as specified in Annex E and chosen by the manufacturer. A.2 Method A.2.1 To determine the degree of contrast between the substrate and the changed indicator agent, the indicator is placed in the centre of a test pack and exposed to a cycle of the steam
47、exposure apparatus at the specified operating temperature required for the indicator to produce uniform colour change. A.2.2 The difference in colour density between the ground colour of the substrate and that of the changed and/or unchanged indicator agent shall be determined on at least three pair
48、s of locations on the indicator, using a reflective densitometer. Paired readings shall be taken equidistantly over the indicator. A.2.3 This test shall be repeated five times for each of three separate production batches of the indicator. BS ISO 11140-5:20076 Annex B (normative) Method of determini
49、ng uniform colour change on exposure to saturated steam B.1 Apparatus B.1.1 Steam exposure apparatus, as specified in Annex G, where the empty chamber includes chamber furniture. B.1.2 Temperature sensors, either Class A platinum resistance thermometers as specified in IEC 60751 or tolerance Class 1 thermocouples as specified in IEC 60584-2. B.1.3 Temperature-recording equipment, with a limit of error of 0,5 C. B.1.4 Standard test pack, as specified in Annex E. B.2 Air removal
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