BS ISO 11140-5-2007 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests《卫生保健品灭菌 化学指示剂 布维-狄(Bowie和Dick)型除气试验用2.pdf
《BS ISO 11140-5-2007 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests《卫生保健品灭菌 化学指示剂 布维-狄(Bowie和Dick)型除气试验用2.pdf》由会员分享,可在线阅读,更多相关《BS ISO 11140-5-2007 Sterilization of health care products - Chemical indicators - Class 2 indicators for Bowie and Dick-type air removal tests《卫生保健品灭菌 化学指示剂 布维-狄(Bowie和Dick)型除气试验用2.pdf(22页珍藏版)》请在麦多课文档分享上搜索。
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
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