EN ISO 15882:2008

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)

ISO 15882:2008 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.
ISO 15882:2008 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 for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO 15882:2008)

1.1   Diese Internationale Norm enthält einen Leitfaden für die Auswahl und Verwendung chemischer Indikatoren und die Interpretation ihrer Ergebnisse, die bei der Festlegung des Verfahrens, bei der Validierung sowie bei der Routineüberwachung und Gesamtkontrolle von Sterilisationsverfahren verwendet werden. Diese Internationale Norm gilt für Indikatoren, die zur Überwachung einer oder mehrer Variablen eines Sterilisationsverfahrens verwendet werden und die Einwirkung des Sterilisationsverfahrens durch physikalische und/oder chemische Stoffänderung anzeigen. Diese chemischen Indikatoren sind in ihrer Wirkung nicht an das Vorhandensein oder Nichtvorhandensein eines lebenden Organismus gebunden.
1.2   Diese Internationale Norm berücksichtigt nicht Indikatoren zum Einsatz bei Verfahren, die auf der Entfernung von Mikroorganismen auf physikalische Weise beruhen, z. B. Filtration.
1.3   Diese Internationale Norm gilt nicht für Indikatoren für kombinierte Verfahren, z. B. für Reinigungs / Desinfektionsgeräte oder CIP (en: cleaning in place = Verfahren zur automatisierten Reinigung von verfahrenstechnischen Apparaten) und SIP (en: sterilization in place = Verfahren zur automatisierten Sterilisation von verfahrenstechnischen Apparaten).

Stérilisation des produits de santé - Indicateurs chimiques - Directives pour la sélection, l'utilisation et l'interprétation des résultats (ISO 15882:2008)

L'ISO 15882:2008 fournit des directives relatives au choix, à l'utilisation et à l'interprétation des résultats des indicateurs chimiques utilisés dans le cadre de la définition, de la validation et de la surveillance régulière des processus, ainsi que dans le contrôle global des procédés de stérilisation.
L'ISO 15882:2008 s'applique aux indicateurs qui marquent l'exposition à un procédé de stérilisation par le biais d'une modification physique et/ou chimique des substances, et qui sont utilisés pour surveiller une ou plusieurs variables nécessaires au procédé de stérilisation. L'action de ces indicateurs chimiques ne dépend pas de la présence ou de l'absence d'un organisme vivant.

Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - Navodilo za izbiro, uporabo in predstavitev rezultatov (ISO 15882:2008)

LJ: Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - Navodilo za izbiro, uporabo in predstavitev rezultatov (ISO/DIS 15882:2006)

General Information

• Status: Published
• Publication Date: 31-Aug-2008
• Withdrawal Date: 30-Mar-2009
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Sep-2008
• Completion Date: 01-Sep-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 15882:2008 - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)

Relations

• Replaces: EN ISO 15882:2003 - Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2003)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2008
1DGRPHãþD
SIST EN ISO 15882:2003
Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - Navodilo za
izbiro, uporabo in predstavitev rezultatov (ISO 15882:2008)
Sterilization of health care products - Chemical indicators - Guidance for selection, use
and interpretation of results (ISO 15882:2008)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren -
Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen (ISO
15882:2008)
Stérilisation des produits de santé - Indicateurs chimiques - Directives pour la sélection,
l'utilisation et l'interprétation des résultats (ISO 15882:2008)
Ta slovenski standard je istoveten z: EN ISO 15882:2008
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15882
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2008
ICS 11.080.01 Supersedes EN ISO 15882:2003
English Version
Sterilization of health care products - Chemical indicators -
Guidance for selection, use and interpretation of results (ISO
15882:2008)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Directives pour la sélection, l'utilisation et l'interprétation Chemische Indikatoren - Leitfaden für die Auswahl,
des résultats (ISO 15882:2008) Verwendung und Interpretation von Ergebnissen (ISO
15882:2008)
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 European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of 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, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15882:2008: E
worldwide for CEN national Members.

Contents Page
Foreword.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 be 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 may 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 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, Switzerland 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.

INTERNATIONAL ISO
STANDARD 15882
Second edition
2008-09-01
Sterilization of health care products —
Chemical indicators — Guidance for
selection, use and interpretation of
results
Stérilisation des produits de santé — Indicateurs chimiques —
Directives pour la sélection, l'utilisation et l'interprétation des résultats

Reference number
ISO 15882:2008(E)
©
ISO 2008
ISO 15882:2008(E)
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ISO 15882:2008(E)
Contents 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 indicators . 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
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 Record 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 “parameter” 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 porosity. 27
Annex E (informative) Figure showing relationship of indicator components. 29
Bibliography . 30

ISO 15882:2008(E)
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.
This second edition cancels and replaces the first edition (ISO 15882:2003) which has been technically
revised.
iv © ISO 2008 – All rights reserved

ISO 15882:2008(E)
Introduction
This International Standard provides guidance for users regarding the selection, use and interpretation of
results of ch
...