1、BS EN ISO15882:2008ICS 11.080.01,NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products Chemical indicators Guidance for selection,use and interpretationof results (ISO15882:2008)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS
2、, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIThis British Standardwas published under the authority of theStandards Policy andStrategy Committee on 31 BSI 2009ISBN 978 0 580 55729 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15882:2008National forewordThis British Standard
3、is the UK implementation of EN ISO 15882:2008.It supersedes BS EN ISO 15882:2003 and which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained o
4、nrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.January 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA
5、STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15882September 2008ICS 11.080.01 Supersedes EN ISO 15882:2003 English VersionSterilization of health care products - Chemical indicators -Guidance for selection, use and interpretation of res
6、ults (ISO15882:2008)Strilisation des produits de sant - Indicateurs chimiques -Directives pour la slection, lutilisation et linterprtationdes rsultats (ISO 15882:2008)Sterilisation von Produkten fr die Gesundheitsfrsorge -Chemische Indikatoren - Leitfaden fr die Auswahl,Verwendung und Interpretation
7、 von Ergebnissen (ISO15882:2008)This European Standard was approved by CEN on 24 August 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date
8、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 in any other language made by translationunder the res
9、ponsibility 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, Estonia, Finland,France, Germany, Greece, Hungary, Ice
10、land, 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 NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Sta
11、ssart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15882:2008: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008EN ISO 15882:2008
12、(E) 3 Foreword This document (EN ISO 15882:2008) 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” the secretariat of which is held by DIN. This European Standard shall b
13、e given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2009, and conflicting national standards shall be withdrawn at the latest by March 2009. Attention is drawn to the possibility that some of the elements of this document ma
14、y be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15882:2003. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound
15、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, Slovakia, Slovenia, Spain, Sweden, Swit
16、zerland and the United Kingdom. Endorsement notice The text of ISO 15882:2008 has been approved by CEN as a EN ISO 15882:2008 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008ISO 15882:2008(E) ISO 2008 Al
17、l rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Terms and definitions. 1 3 General considerations 3 4 Classes of chemical indicator . 5 4.1 General. 5 4.2 Class 1: Process indicators. 5 4.3 Class 2: Indicators for use in specific tests. 6 4.4 Class 3: Single variable indi
18、cators . 6 4.5 Class 4: Multi-variable indicators 8 4.6 Class 5: Integrating indicators 8 4.7 Class 6: Emulating indicators . 9 5 Selection of chemical indicators. 10 6 Use of chemical indicators 10 6.1 Class 1 process indicators 10 6.2 Class 2 indicators . 11 6.3 Class 3, 4, 5 and 6 indicators. 11
19、6.4 Indicators for use with process challenge devices. 11 7 Interpretation of results from chemical indicators 12 7.1 General. 12 7.2 Chemical indicator responses. 12 7.3 Chemical indicators showing “fail” response . 12 8 Chemical indicators in sterility assurance procedures 12 8.1 General. 12 8.2 R
20、ecord keeping . 13 9 Personnel training 13 10 Storage and handling . 14 11 Labelling 14 11.1 General. 14 11.2 Indicator marking 14 11.3 Process marking. 14 11.4 Package marking 14 Annex A (informative) Background on the Bowie and Dick test . 16 Annex B (informative) Explanation of the terms “paramet
21、er” and “variable” . 19 Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in the ISO 11138 series and microbial inactivation (derived from ISO 11140-1) 20 Annex D (informative) Specifications for
22、 porosity 27 Annex E (informative) Figure showing relationship of indicator components 29 Bibliography . 30 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008ISO 15882:2008(E) iv ISO 2008 All rights reservedForeword ISO (the Intern
23、ational Organization for Standardization) is a worldwide federation of 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 b
24、een 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 work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical sta
25、ndardization. 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 International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies f
26、or 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 the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or a
27、ll such patent rights. ISO 15882 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 15882:2003) which has been technically revised. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08
28、:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008ISO 15882:2008(E) ISO 2008 All rights reserved vIntroduction This International Standard provides guidance for users regarding the selection, use and interpretation of results of chemical indicators intended for use with sterilization processes empl
29、oying steam, dry heat, ethylene oxide, or radiation, low temperature steam and formaldehyde (LTSF), or vapourized hydrogen peroxide as documented in ISO 11140-1 13. The ISO 11140 12, 13, 14, 15, 16series of standards specifies performance requirements for chemical indicators. These standards are int
30、ended primarily for the use of manufacturers of chemical indicators. The guidance in this document is of a general nature; chemical indicators do not, of themselves, constitute a comprehensive monitoring programme with regard to the sterilization of health care products. Users attention is drawn to
31、the requirements for validation of sterilization processes specified in ISO 14937 18for general processes, the ISO 17665 19, 20series for moist heat sterilization, the ISO 11135 5, 6series for ethylene oxide sterilization, ISO 11137-1 7for radiation sterilization and ISO 20857 22for dry heat sterili
32、zation. The actual use/frequency of chemical indicators might be regulated by international and or national standards as well as by local regulatory authorities. The need for convenient and rapid means of detecting sterilization problems occurring during sterilization processes has brought about the
33、 development of sterilization process monitors generally referred to as “chemical indicators.” In this International Standard, users will find guidance on selection of the correct chemical indicator for their particular sterilization process and critical parameters as well as guidance on its appropr
34、iate use. The complexity of modern medical technology and the wide variety of sterilization processing techniques and equipment available have made effective sterility assurance programmes more challenging than ever before. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Unc
35、ontrolled Copy, (c) BSIBS EN ISO 15882:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008INTERNATIONAL STANDARD ISO 15882:2008(E) ISO 2008 All rights reserved 1Sterilization of health care products Chemical indicators Guidance
36、for selection, use and interpretation of results 1 Scope 1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This In
37、ternational Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their ac
38、tion on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combinatio
39、n processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place). 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE A vocabulary of terms used for sterilization of health care products is provided in IS
40、O/TS 1113911. 2.1 chemical indicator non-biological indicator test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process ISO/TS 11139, definition 2.6 2.2 endpoint point of the observed change as defined by
41、the manufacturer occurring after the indicator has been exposed to specified stated values ISO 11140-1, definition 3.3 2.3 indicator combination of the indicator agent and its substrate in the final form in which it is intended to be used ISO 11140-1 definition 3.5 NOTE 1 An indicator system in comb
42、ination with a specific test load is also termed an indicator. NOTE 2 See Annex E. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008ISO 15882:2008(E) 2 ISO 2008 All rights reserved2.4 indicator agent indicator reagent active subst
43、ance(s) or combination of substances ISO 11140-1, definition 3.6 NOTE See Annex E. 2.5 process challenge device PCD item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process ISO/TS 11139, definition 2.33 2.6 process challenge location P
44、CL site which represents “worst case” conditions as they are given for sterilizing agent(s) in the goods to be sterilized 2.7 process parameter specified value for a process variable ISO/TS 11139, definition 2.34 NOTE 1 The specification for a sterilization process includes the process parameters an
45、d their tolerances. NOTE 2 See Annex B. 2.8 process variable condition within a sterilization process, changes in which alter microbicidal effectiveness ISO/TS 11139, definition 2.35 EXAMPLES Time, temperature, pressure, concentration, humidity, wavelength. NOTE See Annex B. 2.9 resistometer test eq
46、uipment designed to create defined combinations of the physical and/or chemical parameters of a sterilization process 2.10 saturated steam water vapour in a state of equilibrium between condensation and evaporation ISO 11140-1 definition 3.11 2.11 stated value SV value or values of a critical variab
47、le at which the indicator is designed to reach its endpoint as defined by the manufacturer ISO 11140-1, definition 3.12 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 22/05/2009 08:22, Uncontrolled Copy, (c) BSIBS EN ISO 15882:2008ISO 15882:2008(E) ISO 2008 All rights reserved 32.12 visible
48、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. ISO 11140-1, definition 3.15 3 General considerations 3.1 All chemical ind
49、icators are intended to provide information about conditions at the location of the indicator within the sterilizer, sterilizer load or PCD. This can alert the user to potential sterilization process failures. 3.2 The value of the information provided by a chemical indicator is dependent upon the class of indicator, number and location of the indicators, being representative of the conditions throughout the sterilizer chamber or load. Representative locations for a load configuration shoul
