SIST EN ISO 15882:2003

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija izdelkov za zdravstveno oskrbo – Kemijski indikatorji - Navodilo za izbiro, uporabo in predstavitev rezultatov (ISO 15882:2003)Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 15882:2003)Stérilisation des produits de santé - Indicateurs chimiques - Lignes directrices pour le choix, l'emploi et l'interprétation des résultats (ISO 15882:2003)Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2003)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 15882:2003SIST EN ISO 15882:2003en01-september-2003SIST EN ISO 15882:2003SLOVENSKI
STANDARD



SIST EN ISO 15882:2003



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 15882March 2003ICS 11.080.01English versionSterilization of health care products - Chemical indicators -Guidance for selection, use and interpretation of results (ISO15882:2003)Stérilisation des produits de santé - Indicateurs chimiques -Lignes directrices pour le choix, l'emploi et l'interprétationdes résultats (ISO 15882:2003)Sterilisation von Produkten für die Gesundheitsfürsorge -Chemische Indikatoren - Leitfaden für die Auswahl,Verwendung und Interpretation von Ergebnissen (ISO15882:2003)This European Standard was approved by CEN on 11 March 2003.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 lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15882:2003 ESIST EN ISO 15882:2003



EN ISO 15882:2003 (E)2CORRECTED
2003-07-16ForewordThis document (EN ISO 15882:2003) 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 be given the status of a national standard, either by publication ofan identical text or by endorsement, at the latest by September 2003, and conflicting nationalstandards shall be withdrawn at the latest by September 2003.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland andthe United Kingdom.Endorsement noticeThe text of ISO 15882:2003 has been approved by CEN as EN ISO 15882:2003 without anymodifications.SIST EN ISO 15882:2003



Reference numberISO 15882:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO15882First edition2003-03-15Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results Stérilisation des produits de santé — Indicateurs chimiques — Lignes directrices pour le choix, l'emploi et l'interprétation des résultats
SIST EN ISO 15882:2003



ISO 15882:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were 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.
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SIST EN ISO 15882:2003



ISO 15882:2003(E) © ISO 2003 — All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 General considerations.2 5 Classes of chemical indicator.3 5.1 General.3 5.2 Class 1: Process indicators.4 5.3 Class 2: Indicators for use in specific tests.4 5.4 Class 3: Single-parameter indicators.4 5.5 Class 4: Multi-parameter indicators.6 5.6 Class 5: Integrating indicators.6 5.7 Class 6: Emulating indicators.8 6 Selection of chemical indicators.9 7 Use of chemical indicators.9 7.1 External chemical indicators.9 7.2 Internal chemical indicators.10 7.3 Indicators for specific test procedures.10 7.4 Indicators for use with process challenge devices.10 8 Interpretation of chemical indicators.11 8.1 General.11 8.2 Chemical indicator responses.11 8.3 Chemical indicators showing “Fail” response.11 9 Chemical indicators in sterility assurance procedures.11 9.1 General.11 9.2 Record keeping.12 10 Labelling of chemical indicators.12 11 Personnel training.13 12 Storage and handling.13 Annex A (informative)
Background information on the Bowie-Dick test.14 Bibliography.17
SIST EN ISO 15882:2003



ISO 15882:2003(E) iv © ISO 2003 — All rights reserved 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 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 work. 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 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 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 15882 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. SIST EN ISO 15882:2003



ISO 15882:2003(E) © ISO 2003 — All rights reserved v Introduction Performance requirements for manufacturers of chemical indicators are contained in the ISO 11140 series. This International Standard provides guidance regarding the selection, use and interpretation of results of chemical indicators used to monitor sterilization processes employing steam, ethylene oxide, γ- or β-radiation, steam-formaldehyde, or dry heat as documented in ISO 11140-1:1995 (amended 1998). The procedures described in this International Standard are of a general nature and do not, of themselves, constitute a comprehensive monitoring programme with regard to the sterilization of health care products. The intent of this International Standard is not to mandate the use of chemical indicators in a process, but to provide guidance for their proper selection and use. National standards should be consulted for information on the use of chemical indicators as well as the frequency of their 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. The need for convenient, inexpensive and rapid means of detecting sterilization problems has brought about the 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, e.g. the choice of an appropriate chemical indicator, as well as guidance on its appropriate use. Harmonization of the International and European standards on chemical indicators, ISO 11140 and EN 867, is in progress.
SIST EN ISO 15882:2003



SIST EN ISO 15882:2003



INTERNATIONAL STANDARD ISO 15882:2003(E) © ISO 2003 — All rights reserved 1 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results 1 Scope 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 control of sterilization processes. This International Standard is applicable to chemical indicators for which International Standards exist (see ISO 11140 series). This International Standard is not applicable to those processes that rely on physical removal of microorganisms, e.g. filtration. This International Standard is not intended to apply to combination processes, for example, washer-disinfectors or flushing and steaming of pipelines. 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 document (including any amendments) applies. ISO 11138-2:1994, Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization ISO 11138-3:1994, Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization ISO 11140-1, Sterilization of health care products — Chemical Indicators — Part 1: General requirements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 endpoint observable change specified by the manufacturer that occurs after the indicator has been exposed to certain predefined physical conditions 3.2 chemical indicator system that reveals a change in one or more predefined process variables based on a chemical or physical change resulting from exposure to a process 3.3 critical parameter parameter identified as being essential to the sterilization process (and requiring monitoring) SIST EN ISO 15882:2003



ISO 15882:2003(E) 2 © ISO 2003 — All rights reserved 3.4 indicator combination of the indicator agent and its substrate in the form in which it is intended to be used 3.5 indicator agent active ingredient or combination of ingredients 3.6 process challenge device PCD item designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process, and used to assess the effective performance of the process 3.7 process challenge location PCL site which represents “worst-case” conditions as they are given for sterilizing agent(s) in the goods to be sterilized 3.8 saturated steam water vapor in a state of equilibrium between condensation and evaporation 3.9 stated value value, or range of values, of a critical parameter to which the indicator is designed to react 3.10 resistometer equipment designed to create defined combinations of the physicochemical variables of a sterilization process within defined limits 4 General considerations 4.1 All chemical indicators are intended to provide information about local conditions within the sterilizing chamber and thus to alert the user to potential sterilization process failures. The basic performance descriptor of any chemical indicator is its “endpoint” response, which is the observable change as specified by the manufacturer that occurs after the indicator has been exposed to certain predefined process conditions. This observable change generally involves either the melting of a chemical substance or a chemical reaction resulting in a colour change. Different classes of chemical indicators have been developed to suit different monitoring needs and to accommodate varying notions of what is the most useful information about the sterilization process. Some types are sensitive to certain specific problems, such as a temperature deficiency, while others can be less sensitive to an individual parameter but can simultaneously test the overall process. Even chemical indicators of the same basic type can differ in response characteristics, means of detecting exposure conditions, and reliability. This International Standard addresses the following classes of chemical indicator:  Class 1: Process indicators  Class 2: Indicators for use in specific tests  Class 3: Single-parameter indicators  Class 4: Multi-parameter indicators  Class 5: Integrating indicators  Class 6: Emulating indicators SIST EN ISO 15882:2003



ISO 15882:2003(E) © ISO 2003 — All rights reserved 3 The classification is based on defined performance characteristics (see ISO 11140-1) rather than on chemical or physical changes as related to specific sterilization processes. For example, in a steam process, some of these products must be exposed to steam for a minimum length of time to achieve the endpoint, some must be exposed to a minimum temperature, some are affected by a combination of temperature and time of exposure, and still others are affected by time, temperature, and saturated steam. In all cases, the user compares the response of the chemical indicator to an endpoint described by the manufacturer. If the endpoint is not reached, the user should assume there is a sterilization processing problem. The user should investigate the cause of the problem. Possible causes are incorrect choice of packaging, improper packaging, improper loading technique, or sterilizer malfunction. 4.2 Though there are other factors that can influence the efficacy of a sterilization process, ISO 11140-1 identifies the critical sterilization parameters for each sterilization process as follows: Process Symbol Critical parameters Steam STEAM Time, temperature and saturated steam Dry heat DRY Time and temperature Ethylene oxide EO Time, temperature, humidity and EO concentration
Irradiation IRRAD Total absorbed dose Steam formaldehyde FORM Time, temperature, humidity and formaldehyde concentration If the use of the indicator is limited to a specific sterilization cycle, this information shall be stated or coded on the product. For example, “STEAM 15-min 121 °C” means that the indicator is for use in a 15-min 121 °C steam sterilization cycle. The box around the word “STEAM” signifies that the indicator can only be used in the steam sterilization process. 4.3 Each indicator shall have a stated value (SV) printed on the product. This stated value, based on the manufacturer’s chosen endpoint for the product, identifies the testing requirements for that specific class of chemical indicator. These conditions are attained using a resistometer.
The resistometer (see ISO 11140-2 for further information) is a special vessel that is designed for very rapid attainment of the particular critical parameters of the sterilization process. These parameters are very closely controlled during the sterilization exposure. Because standard sterilizers do not have the same response or accuracy of exposure conditions as found in resistometers, it is nearly impossible for a user to replicate manufacturer label claims.
4.4 Selection of the basic classes of chemical indicators that are best suited to a particular application are questions that can be answered only in the context of a basic understanding of the sterilization process, the possible problems that prevent sterilization, the performance characteristics of various classes of chemical indicators, and what constitutes an effective sterility assurance programme. Once an indicator is selected, it will be of value in sterility assurance only if it is used and interpreted correctly, and if the user responds appropriately to the results. 5 Classes of chemical indicator 5.1 General With the exception of some indicators used in specific tests, chemical indicators are used to directly or indirectly detect whether or not one or more critical process parameters have reached a certain predetermined level in a given sterilization process. Which parameters need to be considered critical and how accurately they should be monitored depends on the tolerances given to specific sterilization parameters. For example, the temperature in moist heat sterilization is of greater importance than in ethylene oxide sterilization. The SIST EN ISO 15882:2003



ISO 15882:2003(E) 4 © ISO 2003 — All rights reserved requirements for the temperature accuracy of a chemical indicator intended for monitoring moist-heat sterilization processes are far stricter than those for a chemical indicator intended for use in monitoring an ethylene oxide sterilization process. In contrast to biological indicators, where many indicators are labelled for use in several different sterilization processes, chemical indicators are usually specific to a sterilization process. The performance characteristics of each class enable the respective chemical indicators to convey different types of information, and therefore perform different functions. In general, progression from “process indicators” to “emulating indicators” will convey more information with greater specificity. The following descriptions for each class of chemical indicator start with an italicized quotation taken directly from ISO 11140-1, which has been used to define that specific class of chemical indicator: 5.2 Class 1: Process indicators Process indicators are intended for use with individual units (e.g. packs, containers) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. (ISO 11140-1, subclause 4.1) This class is useful in aiding production flow (i.e. identifying loads yet to be processed versus those processed and ready for distribution). Class 1 process indicators are typically applied to, or visible from, the outside of packages. Examples of Class 1 process indicators include sterilization tape and packaging printed with colour-changing chemically-indicating inks. Because these chemical indicators are typically external and exposed directly to the sterilization environment without the resistance imposed by packaging, they typically “fail” only when there
is gross malfunction. Class 1 process indicators are intended to reach their endpoint after exposure to a
sub-optimal sterilization cycle. Chemical indicators intended for use in monitoring γ- or β-irradiation exist only as Class 1 process indicators. 5.3 Class 2: Indicators for use in specific tests These indicators are designed for use in specific test procedures as defined in relevant sterilizer/sterilization standards. (ISO 11140-1, subclause 4.2) Bowie-Dick type indicators are commercially available as special test sheets or in disposable packs containing such test sheets. At this time, the only chemical indicator widely recognized in Class 2 are the Bowie-Dick type indicators which are defined in ISO 11140-3, ISO 11140-4 and ISO 11140-5. Class 2 Bowie-Dick type indicators are intended to demonstrate the rapid and even penetration of steam and, by implication, the adequacy of air removal. This condition is demonstrated by a uniform colour change on the indicator sheet. Causes of failure can include the evolution of volatile compounds within the test pack or the presence of
non-condensable gases in the steam. Because Bowie-Dick type indicators are designed to reach the endpoint after a specified exposure that can be different from that required to achieve effective sterilization, they may not be appropriate for use as routine sterilization cycle indicators. It should be noted that extending the exposure time for the Bowie-Dick test, or disregarding the manufacturer’s recommendations for how to conduct the Bowie-Dick test, can entirely defeat the purpose of the test by causing misleading endpoint development. For background information on the Bowie-Dick Test, see Annex A. 5.4 Class 3: Single-parameter indicators A single-parameter indicator shall be designed for one of the critical parameters and shall indicate exposure to a sterilization cycle at a stated value of the chosen parameter. (ISO 11140-1, subclause 4.3) SIST EN ISO 15882:2003



ISO 15882:2003(E) © ISO 2003 — All rights reserved 5 A single-parameter indicator is intended to respond to only one critical parameter of the sterilization process. The parameter and its stated value will be provided by the indicator manufacturer. Care shall be taken when interpreting the results obtained from single-parameter indicators. Most sterilization processes have more than one critical parameter which must be attained if sterilization is to occur. Table 1 from ISO 11140-1:1995 contains tolerances (upper and lower limits of performance acceptability for the chemical indicator, when tested by the manufacturer) that need to be met for each critical parameter. The limiting values are the predetermined conditions that the manufacturer shall maintain during testing. That table is reproduced here: Table 1 — Tolerances and limiting values for the response to critical parameters
for Class 3 and Class 4 indicators Time Temperature Gas concentrationRelative humidity
Limiting
values Saturation Refers to the steam supply to the chamber Sterilization method min. °C mg/l % LLa
ULb
Steam SVc 0–25% SV 0–2C°
0,85 1,0 Dry heat SV 0–25% SV 0–5C°
Ethylene oxide SV 0–25% SV 0–5C° SV 0–25% > 30 %
Steam-formaldehyde SV 0–25% SV 0–3C° SV 0–20%
0,85 1,0 a LL = lower limit (dryness value). b UL = upper limit (dryness value). c SV = stated value: reaction value identified for the product with respect to a critical parameter; it is either stated or coded on the product.
EXAMPLE 1 Time tolerance: SV 0–25% If SV = 4 min SV + 0 = 4 min SV — 25 % = 3 min EXAMPLE 2 Gas concentration tolerance: SV = 0–25% If SV = 600 mg/l
SV + 0 = 600 mg/l SV – 25 % = 450 mg/l For example, a single-parameter indicator for temperature can only indicate the attainment of a stated temperature value and provides no information as to the total time at temperature. Also, it does not provide information on any other critical parameter, such as the presence of steam. SIST EN ISO 15882:2003



ISO 15882:2003(E) 6 © ISO 2003 — All rights reserved However, the indicator can reveal whether a specific minimum temperature was attained at a particular location within the sterilizer chamber or the load. This temperature is the endpoint temperature and the indicator must be correctly selected for the minimum temperature of the process. Single-parameter indicators should be supplemented by other means of monitoring the sterilization process. 5.5 Class 4: Multi-parameter indicators A multi-parameter indicator shall be designed for two or more of the critical parameters and shall indicate exposure to a sterilization cycle at stated values of the chosen parameters. (ISO 11140-1, subclause 4.4) The manufacturer states the conditions under which multi-parameter chemical indicators reach their endpoint. These indicators typically provide more information than either process (Class 1) or single parameter (Class 3) indicators. Chemical indicators are designed to reach their endpoint when preset critical parameters have been met. Most multi-parameter indicators are based on a chemical and/or physical change that results in a colour change or in the migration of a chemical. These reactions take place at a defined rate at a stated temperature; usually the rate increases as the temperature of the process increases. The ISO 11140-1 standard contains tolerances (upper and lower limits of performance acceptability for the chemical indicator, when tested by the manufacturer) that need to be met for each critical parameter. See Table 1. An example of multi-parameter indicator performance is given below. Although all parameters have been altered simultaneously in the example, in practice when the manufacturers test the indicators, they may vary one or more parameters while holding the remaining parameters at the stated value. EXAMPLE Ethylene oxide sterilization indicator (Class 4: Multi-parameter indicator) Stated values: 60 min at 900 mg/l Table 1 provides the tolerances and limiting values (upper and lower limits of performance)
for this Class 4 indicator. The tolerances from this table are 60 min 0–25% and 900 mg/l 0–25%
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