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
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

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
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ii © ISO 2003 — All rights reserved
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
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.
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 ox
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