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1、 Reference number ISO 11140-1:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 11140-1 Second edition 2005-07-15 Sterilization of health care products Chemical indicators Part 1: General requirements Strilisation des produits de sant Indicateurs chimiques Partie 1: Exigences gnrales Copyright Internation
2、al Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) PDF disclaimer This PDF file may contain embedde
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5、e optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless otherwise specifi
6、ed, 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 country of the requester. ISO copyright office Case
7、 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 2005 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standard
8、s 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) ISO 2005 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Classification
9、. 3 5 General requirements. 4 6 Performance requirements 6 7 Test methods. 7 8 Additional requirements for process (Class 1) indicators . 10 9 Additional requirements for single variable (Class 3) indicators 13 10 Additional requirements for multi-variable (Class 4) indicators 13 11 Additional requi
10、rements for steam integrating (Class 5) indicators. 14 12 Additional requirements for dry heat integrating (Class 5) indicators . 14 13 Additional requirements for ethylene oxide integrating (Class 5) indicators 15 14 Additional requirements for emulating (Class 6) indicators 16 Annex A (informative
11、) Method for demonstrating shelf life of the product . 17 Annex B (informative) Examples of testing indicators. 18 Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in ISO 11138 and microbial ina
12、ctivation 19 Annex D (informative) Rationale for the liquid-phase test method for steam-formaldehyde indicators. 25 Annex E (informative) Relationship of indicator components. 26 Bibliography. 27 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee
13、=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) iv ISO 2005 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of nati
14、onal standards bodies (ISO member bodies). The work of preparing International Standards is normally 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. Internat
15、ional organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the ru
16、les given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International 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
17、 least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the 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 11140-1 was prepared by Technical Committee ISO/
18、TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11140-1:1995 and ISO 11140-1:1995/Amd.1:1998), which has been technically revised. ISO 11140 consists of the following parts, under the general title Sterilization of health care products C
19、hemical indicators: Part 1: General requirements Part 2: Test equipment and methods Part 3: Class 2 indicators for steam penetration test sheets Part 4: Class 2 indicators for steam penetration test packs Part 5: Class 2 indicators for air removal test sheets and packs NOTE ISO 11140-2 is to be repl
20、aced by ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reprodu
21、ction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) ISO 2005 All rights reserved v Introduction This part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat,
22、ethylene oxide, or radiation, steam-formaldehyde or vaporized hydrogen peroxide. Additional requirements for indicators intended for use with other sterilization methods (e.g. other forms of moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general requi
23、rements will apply. The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of ISO 11140. Standards for sterilizers and for the validation and process control of sterilization, describe performance tests for sterilizers and methods of validation and
24、 routine control, respectively. This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general requirements for chemical indicators. Subsequent parts of this International Standard specify the particular requirements for chemical indicators for particular appli
25、cations and for defined tests of particular sterilization processes used in health care, including industry. The use of the indicators specified in this part of ISO 11140 are described in ISO 15882, EN 285, ISO 11135 and ISO 17665. Resistometers (see ISO 18472) are used to characterize the performan
26、ce of the chemical indicators described in this part of ISO 11140. Resistometers allow for precise variation of the specific test conditions and cycle sequences in order to produce controlled physical studies. Resistometers differ from conventional sterilizers; therefore, if conventional sterilizers
27、 are used to attempt to duplicate resistometer conditions, erroneous and/or misleading results may occur. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduct
28、ion or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license fro
29、m IHS -,-,- INTERNATIONAL STANDARD ISO 11140-1:2005(E) ISO 2005 All rights reserved 1 Sterilization of health care products Chemical indicators Part 1: General requirements WARNING The use of this part of ISO 11140 may involve hazardous materials, operations and equipment. This part of ISO 11140 doe
30、s not purport to address to all the safety problems associated with its use. It is the responsibility of the user of this part of ISO 11140 to establish appropriate safety and health practise and determine the applicability of regulatory limitations prior to use. 1 Scope 1.1 This part of ISO 11140 s
31、pecifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not depen
32、dent for their action on the presence or absence of a living organism. NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biol
33、ogical indicators (BIs). 1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply. Relevant
34、 test equipment is described in ISO 18472. NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated
35、 references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 11138 (all parts), Sterilization of hea
36、lth care products Biological indicator systems ISO 11607, Packaging for terminally sterilized medical devices ISO 184721), Sterilization of health care products Biological and chemical indicators Test equipment 1) To be published. Copyright International Organization for Standardization Provided by
37、IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) 2 ISO 2005 All rights reserved 3 Terms and definitions For the purposes of this document, the fo
38、llowing terms and definitions apply. 3.1 bleed lateral migration of the indicator agent beyond the margins within which the indicator agent was applied 3.2 critical variable parameters identified as being essential to the sterilization process (and requiring monitoring) 3.3 endpoint point of the obs
39、erved change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values 3.4 graduated response progressive observable change occurring on exposure to one or more process variables allowing assessment of the level achieved 3.5 indicator combination of the
40、 indicator agent and its substrate in the final form in which it is intended to be used (see Annex E) NOTE An indicator system in combination with a specific test load is also termed an indicator. 3.6 indicator agent/indicator reagent active substance(s) or combination of substances (see Annex E) 3.
41、7 indicator system combination of the indicator agent and its substrate subsequently intended to be used in combination with a specific test load 3.8 off-set transfer of indicator agent to a material in intimate contact with the surface of the indicator 3.9 parameter specified value for a process va
42、riable 3.10 penetration migration of the indicator agent through the substrate to the surface opposite the one to which the indicator agent was applied 3.11 saturated steam water vapour in a state of equilibrium between condensation and evaporation Copyright International Organization for Standardiz
43、ation Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 20:51:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11140-1:2005(E) ISO 2005 All rights reserved 3 3.12 stated value SV value or values of a criti
44、cal variable at which the indicator is designed to reach its endpoint as defined by the manufacturer 3.13 substrate carrier or support material onto which the indicator is applied (see Annex E) 3.14 variable condition within a sterilization process, changes that alter microbicidal effectiveness 3.15
45、 visible change change defined by the manufacturer, which can be seen in the indicator after exposure to one or more critical variables of the process NOTE Visible change is used to describe the response of Class 1 process indicators. 4 Classification 4.1 General In subsequent parts of ISO 11140, in
46、dicators are classified by their intended use. The chemical indicators described in this part of ISO 11140 are classified into six groups. The chemical indicators within each of these classifications are further subdivided by the sterilization process for which they are designed to be used. The clas
47、sification structure used is solely to denote the characteristics and intended use of each type of indicator when used as defined by the manufacturer. This classification has no hierarchical significance. 4.2 Class 1: process indicators Process indicators are intended for use with individual units (
48、e.g. packs, containers) to indicate that the unit has been directly exposed to the sterilization process and to distinguish between processed and unprocessed units. They shall be designed to react to one or more of the critical process variables (see Tables 1 to 6). 4.3 Class 2: indicators for use in specific tests Class 2 indicators are intended for use in specific test procedures as defined in relevant sterilizer/sterilization standards. NOTE The requirem