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1、BRITISH STANDARD BS EN ISO 11140-1:2005 Sterilization of health care products Chemical indicators Part 1: General requirements The European Standard EN ISO 11140-1:2005 has the status of a British Standard ICS 11.080.01 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006
2、, Uncontrolled Copy, (c) BSI BS EN ISO 11140-1:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 22 February 2006 BSI 22 February 2006 ISBN 0 580 47715 0 National foreword This British Standard is the official English language version of E
3、N ISO 11140-1:2005. It is identical with ISO 11140-1:2005. It supersedes BS EN 867-1:1997 and BS EN 867-2:1997 which are withdrawn. The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, which has the responsibility to: A list o
4、f organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards
5、Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does
6、 not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developmen
7、ts and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 16, an inside back cover and a back cover. The BSI copyright notice displayed
8、in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00
9、 2006, Uncontrolled Copy, (c) BSI EN ISO 11140-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11140-1:2005(E) INTERNATIONAL STANDARD ISO 11140-1 Second edition 2005-07-15 Sterilization of health care products Che
10、mical indicators Part 1: General requirements Strilisation des produits de sant Indicateurs chimiques Partie 1: Exigences gnrales EN ISO 11140-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun,
11、na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1Scope . 1 2Normative references. 1 3Terms and definitions. 2 4Classification. 3 5General requirements. 4 6Performance requirements 6 7Test methods. 7 8Additional requirements for process
12、(Class 1) indicators . 10 9Additional requirements for single variable (Class 3) indicators 13 10Additional requirements for multi-variable (Class 4) indicators 13 11Additional requirements for steam integrating (Class 5) indicators. 14 12Additional requirements for dry heat integrating (Class 5) in
13、dicators . 14 13Additional requirements for ethylene oxide integrating (Class 5) indicators 15 14Additional requirements for emulating (Class 6) indicators 16 Annex A (informative) Method for demonstrating shelf life of the product . 17 Annex B (informative) Examples of testing indicators. 18 Annex
14、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 inactivation 19 Annex D (informative) Rationale for the liquid-phase test method for steam-formaldehyde indicators. 25 Annex
15、 E (informative) Relationship of indicator components. 26 Bibliography. 27 EN ISO 11140-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of
16、national 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. Inte
17、rnational 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 th
18、e rules 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 b
19、y at 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
20、ISO/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 produc
21、ts Chemical 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
22、 is to be replaced by ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment. EN ISO 11140-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction This part of ISO 11140 specifies per
23、formance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat, ethylene oxide, ? or ? radiation, steam-formaldehyde or vaporized hydrogen peroxide. Additional requirements for indicators intended for use with other steriliza
24、tion methods (e.g. other forms of moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general requirements will apply. The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of ISO 11140. Standards for st
25、erilizers and for the validation and process control of sterilization, describe performance tests for sterilizers and methods of validation and routine control, respectively. This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general requirements for chemic
26、al indicators. Subsequent parts of this International Standard specify the particular requirements for chemical indicators for particular applications and for defined tests of particular sterilization processes used in health care, including industry. The use of the indicators specified in this part
27、 of ISO 11140 are described in ISO 15882, EN 285, ISO 11135 and ISO 17665. Resistometers (see ISO 18472) are used to characterize the performance of the chemical indicators described in this part of ISO 11140. Resistometers allow for precise variation of the specific test conditions and cycle sequen
28、ces in order to produce controlled physical studies. Resistometers differ from conventional sterilizers; therefore, if conventional sterilizers are used to attempt to duplicate resistometer conditions, erroneous and/or misleading results may occur. EN ISO 11140-1:2005 Licensed Copy: sheffieldun shef
29、fieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Sterilization of health care products Chemical indicators Part 1: General requirements WARNING The use of thi
30、s part of ISO 11140 may involve hazardous materials, operations and equipment. This part of ISO 11140 does 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
31、 determine the applicability of regulatory limitations prior to use. 1 Scope 1.1 This part of ISO 11140 specifies 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 monito
32、r the attainment of one or more of the variables required for a sterilization process. They are not dependent 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 o
33、f the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological 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
34、added to by a subsequent part, in which case the requirement of that particular part will apply. Relevant 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 refere
35、nces 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 document (including any amendments) applies. ISO 8601, Data elements and interchange form
36、ats Information interchange Representation of dates and times ISO 11138 (all parts), Sterilization of health care products Biological indicator systems ISO 11607, Packaging for terminally sterilized medical devices ISO 184721), Sterilization of health care products Biological and chemical indicators
37、 Test equipment 1) To be published. EN ISO 11140-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 bleed lateral migration of th
38、e 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 observed change as defined by the manufacturer occurring after the indica
39、tor 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 indicator agent and its substrate in the final form in which it is in
40、tended 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) 3.7 indicator system combination of the indicator agent and its substrat
41、e 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 variable 3.10 penetration migration of the indicator agent through the s
42、ubstrate 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 EN ISO 11140-1:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:47 GMT+00:00 2006, Uncontrolled Copy, (c
43、) BSI 3 3.12 stated value SV value or values of a critical 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 proc
44、ess, changes that alter microbicidal effectiveness 3.15 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 Classifi
45、cation 4.1 General In subsequent parts of ISO 11140, indicators 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 p
46、rocess for which they are designed to be used. The classification 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
47、indicators are intended for use with individual units (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
48、 (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 requirements for specific test indicators (Class 2 indicators) are provided in other parts o
49、f ISO 11140. 4.4 Class 3: single variable indicators A single variable indicator shall be designed to react to one of the critical variables (see 5.2) and is intended to indicate exposure to a sterilization process at a stated value (SV) of the chosen variable (see 5.7 and 5.8). 4.5 Class 4: multi-variable indicators A multi-variable indicator shall be designed to react to two or more of the critical variables (see 5.2) and is intended to indicate exposure to a sterilization c