EN ISO 18472:2006
(Main)Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
ISO 18472:2006 specifies the requirements for test equipment to be used to test chemical and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the ISO 11138 series for biological indicators. ISO 18472:2006 also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische und chemische Indikatoren - Prüfausrüstung (ISO 18472:2006)
1.1 Diese Internationale Norm legt die Anforderungen an die Prüfausrüstung fest, die bei der Prüfung chemischer und biologischer Indikatoren für Verfahren mit Dampf, Ethylenoxid, trockener Hitze und verdampftem Hydrogenperoxid (Wasserstoffperoxid) auf Übereinstimmung mit den in ISO 11140 1 für chemische Indikatoren oder der Normenreihe ISO 11138 für biologische Indikatoren angegebenen Anfor¬derungen zu verwenden ist. Diese Internationale Norm stellt auch informative Verfahren zur Verfügung, die bei der Merkmalsbestimmung der Leistung biologischer und chemischer Indikatoren für ihre vorgesehene Verwendung und bei der Routineprüfung der Qualitätskontrolle nützlich sind.
ISO 11138 2, ISO 11138 3, ISO 11138 4 und ISO 11140 1 erfordern die Verwendung von Resistometern, die in dieser Norm festgelegt sind, und diese Resistometer werden im Zusammenhang mit den Prüfverfahren, welche in den entsprechenden Teilen von ISO 11138 und ISO 11140 festgelegt sind, verwendet.
ANMERKUNG Resistometer für Indikatoren für die Formaldehyd-Sterilisation sind nicht in diese Internationale Norm aufgenommen. Prüfverfahren für die Dampf-Formaldehyd-Sterilisation unter Anwendung von Laborgeräten finden sich in ISO 11138 5, ISO 11140 3 und ISO 11140-4.
1.2 Diese Internationale Norm befasst sich nicht mit den Verfahren, die zum Nachweis der Überein¬stimmung biologischer oder chemischer Indikatoren mit ISO 11138 und ISO 11140 angewendet werden, da diese in den entsprechenden Teilen dieser Normen behandelt werden. Indikatoren für kombinierte Verfahren wie bei Reinigungs /Desinfektionsgeräten sind in dieser Internationalen Norm nicht erfasst.
ANMERKUNG Die für ISO 11140 3, ISO 11140 4 oder ISO 11140 5 erforderlichen Prüfausrüstungen und Verfahren sind in diesen Normen festgelegt.
1.3 Diese Internationale Norm behandelt nicht Gesichtspunkte der Sicherheit der Prüfausrüstung, da diese gewöhnlich durch besondere regionale, nationale oder örtliche Bestimmungen geregelt werden.
Stérilisation des produits de santé - Indicateurs biologiques et chimiques - Appareillage d'essai (ISO 18472:2006)
L'ISO 18472:2006 spécifie les exigences relatives à l'équipement d'essai à utiliser pour s'assurer de la conformité des indicateurs chimiques et biologiques des procédés à la vapeur, à l'oxyde d'éthylène, à la chaleur sèche et au peroxyde d'hydrogène gazeux avec les exigences indiquées dans l'ISO 11140-1 relative aux indicateurs chimiques et dans la série de l'ISO 11138 relative aux indicateurs biologiques. L'ISO 18472:2006 fournit également des méthodes informatives permettant de qualifier les performances des indicateurs biologiques et chimiques pour l'usage prévu et pour les essais de contrôle qualité de routine.
Sterilizacija izdelkov za zdravstveno nego - Biološki in kemični indikatorji - Preskusna oprema (ISO 18472:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2006
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3UHVNXVQDRSUHPD ,62
Sterilization of health care products - Biological and chemical indicators - Test equipment
(ISO 18472:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische und chemische
Indikatoren - Prüfausrüstung (ISO 18472:2006)
Stérilisation des produits de santé - Indicateurs biologiques et chimiques - Appareillage
d'essai (ISO 18472:2006)
Ta slovenski standard je istoveten z: EN ISO 18472:2006
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 18472
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.080.01
English Version
Sterilization of health care products - Biological and chemical
indicators - Test equipment (ISO 18472:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
et chimiques - Appareillage d'essai (ISO 18472:2006) Biologische und chemische Indikatoren - Prüfausrüstung
(ISO 18472:2006)
This European Standard was approved by CEN on 19 May 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18472:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 18472:2006) 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 December 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
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.
Endorsement notice
The text of ISO 18472:2006 has been approved by CEN as EN ISO 18472:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 18472
First edition
2006-06-01
Sterilization of health care products —
Biological and chemical indicators —
Test equipment
Stérilisation des produits de santé — Indicateurs biologiques et
chimiques — Appareillage d'essai
Reference number
ISO 18472:2006(E)
©
ISO 2006
ISO 18472:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 18472:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Performance requirements for resistometers . 4
4.1 Intended use. 4
4.2 Measurement and control capabilities . 4
4.3 Test methods. 4
4.4 Leak test. 4
4.5 Steam resistometer performance requirements. 4
4.6 Ethylene oxide resistometer performance requirements. 7
4.7 Dry heat (heated air) resistometer performance requirements . 9
4.8 Vaporized hydrogen peroxide process resistometer performance requirements. 11
5 Recording systems. 12
5.1 Measurement systems. 12
5.2 Calibration. 12
6 Documentation. 12
6.1 General. 12
6.2 Minimum information . 13
Annex A (informative) Additional performance characterization — Steam . 14
Annex B (informative) Additional performance characterization — Ethylene oxide. 17
Annex C (informative) Additional performance characterization – Dry heat . 20
Annex D (informative) Resistometer documentation and derivations. 22
Bibliography . 28
ISO 18472:2006(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 18472 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This first edition of ISO 18472 partially replaces ISO 11140-2.
iv © ISO 2006 – All rights reserved
ISO 18472:2006(E)
Introduction
To test the performance of chemical and biological indicators, specific test equipment is required. This
International Standard specifies the performance requirements for the test equipment to be used in order to
establish the response of chemical and biological indicators to critical process variables. This International
Standard does not apply to test equipment for irradiation indicators or low temperature steam and
formaldehyde indicators.
Resistometers constitute test equipment designed to create precise and repeatable sterilizing environments,
allowing the evaluation of their effect on biological inactivation kinetics, chemical reactions, material
degradation and product bioburden. Resistometers allow precise variation of the environmental conditions and
cycle sequences in order to produce controlled physical studies. When used with the defined test methods
given in ISO 11138 for biological indicators and ISO 11140 for chemical indicators, the results of these studies
can be used to demonstrate conformance of biological indicators and chemical indicators to these standards.
Resistometers differ from conventional sterilizers. Instrumentation selection and control requirements for
resistometers are based upon mathematical models in which rates of reaction, measurement accuracy and
process control requirements are evaluated to quantify the effects induced by test equipment-controlled
variables. The requirements for accurate measurement, precise control, and rapid rates of change approach
limits of commercially available process control and calibration instrumentation accuracy. The measurement
and control requirements often prohibit practical validation of a resistometer using procedures that might be
employed in a conventional heat or chemical sterilization system. Resistometers are considered test
equipment rather than sterilizers; therefore, an understanding of instrumentation and process design is critical
in clarifying requirements on precision and accuracy. Practical design has to consider the following:
⎯ achievable measurement and control;
⎯ acceptable equipment induced variation in test results;
⎯ economic design (utilizing tight process controls only where required);
⎯ test method correlation with intended use;
⎯ historical knowledge applied to test procedures and an understanding of micro-environmental physical
phenomena;
⎯ testing and analysis alternatives, when accurate quantitative determinations exceed physical
measurement/control limits.
INTERNATIONAL STANDARD ISO 18472:2006(E)
Sterilization of health care products — Biological and chemical
indicators — Test equipment
1 Scope
1.1 This International Standard specifies the requirements for test equipment to be used to test chemical
and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for
conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the
ISO 11138 series for biological indicators. This International Standard also provides informative methods
useful in characterizing the performance of biological and chemical indicators for intended use and for routine
quality control testing.
ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this
International Standard, and these resistometers are used in conjunction with the test methods specified in the
appropriate parts of ISO 11138 and ISO 11140.
NOTE Resistometers for formaldehyde indicators are not included in this International Standard. Test methods using
laboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and ISO 11140-4.
1.2
...
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