EN ISO 18472:2018
(Main)Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
This document specifies the requirements for test equipment to be used to:
— test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series;
— test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140‑1:2014.
This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing.
This document does not specify requirements for test equipment for processes specifically for testing chemical and biological indicators intended to monitor isolator and room biodecontamination processes at atmospheric pressure.
ISO 11138‑2:2017, ISO 11138‑3:2017, ISO 11138‑4:2017 and ISO 11140‑1:2014 require the use of resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 series and ISO 11140 series.
Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138‑5:2017.
Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140‑3:2007, ISO 11140‑4:2007, and ISO 11140‑5:2007.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische und chemische Indikatoren - Prüfausrüstung (ISO 18472:2018)
Stérilisation des produits de santé - Indicateurs biologiques et chimiques - Appareillage d'essai (ISO 18472:2018)
Le présent document spécifie les exigences relatives à l'équipement d'essai à utiliser pour:
— s'assurer de la conformité des indicateurs biologiques des procédés de stérilisation à la vapeur, à l'oxyde d'éthylène gazeux et à la chaleur sèche avec les exigences indiquées dans la série ISO 11138;
— s'assurer de la conformité des indicateurs chimiques des procédés de stérilisation à la vapeur, à l'oxyde d'éthylène gazeux, à la chaleur sèche et au peroxyde d'hydrogène vaporisé avec les exigences indiquées dans l'ISO 11140‑1:2014.
Le présent document fournit également des méthodes informatives permettant de caractériser les performances des indicateurs biologiques et chimiques pour l'usage prévu et pour les essais de contrôle qualité de routine.
Le présent document ne spécifie pas les exigences relatives à l'équipement d'essai pour les procédés spécifiques aux essais des indicateurs biologiques et chimiques destinés à surveiller les procédés d'isolateur et de biodécontamination des salles à la pression atmosphérique.
L'ISO 11138‑2:2017, l'ISO 11138‑3:2017, l'ISO 11138‑4:2017 et l'ISO 11140‑1:2014 requièrent l'utilisation des résistomètres spécifiés dans le présent document et ces résistomètres sont utilisés conjointement avec les méthodes d'essai spécifiées dans les parties applicables de la série ISO 11138 et de la série ISO 11140.
Les résistomètres utilisés pour traiter les indicateurs à la vapeur d'eau et au formaldéhyde à basse température ne sont pas abordés dans le présent document. Les méthodes d'essai utilisant un appareillage de laboratoire pour la vapeur d'eau et le formaldéhyde à basse température sont indiquées dans l'ISO 11138‑5:2017.
Les équipements d'essai des indicateurs chimiques de classe 2 (par exemple Bowie et Dick) sont spécifiés dans l'ISO 11140‑3:2007, l'ISO 11140‑4:2007 et l'ISO 11140‑5:2007.
Sterilizacija izdelkov za zdravstveno nego - Biološki in kemični indikatorji - Preskusna oprema (ISO 18472:2018)
Ta dokument določa zahteve za preskusno opremo za:
– preskušanje bioloških indikatorjev za sterilizacijo s paro, etilenoksidnim plinom in suho toploto za namene izpolnitve zahtev iz skupine standardov ISO 11138;
– preskušanje kemičnih indikatorjev za sterilizacijo s paro, etilenoksidnim plinom, suho toploto in uplinjenim vodikovim peroksidom za namene izpolnitve zahtev iz standarda ISO 11140-1:2014.
Ta dokument vsebuje tudi informativne metode, ki so uporabne za opis učinkovitosti bioloških in kemičnih indikatorjev za predvideno uporabo ter za redne preskuse kontrole kakovosti.
Ta dokument ne določa zahtev za preskusno opremo za postopke, specifične za preskušanje kemičnih in bioloških indikatorjev, ki so namenjeni spremljanju procesov biološke dekontaminacije izolatorja in prostorov
pri atmosferskem tlaku.
ISO 11138-2:2017, ISO 11138-3:2017, ISO 11138-4:2017 in ISO 11140-1:2014 zahtevajo uporabo merilnikov odpornosti, opredeljenih v tem dokumentu, pri čemer se ti merilniki uporabljajo skupaj s preskusnimi metodami, določenimi v ustreznih delih skupin standardov ISO 11138 in ISO 11140.
Ta dokument ne zajema merilnikov odpornosti za indikatorje pri postopkih s paro nizke temperature in formaldehidom. Preskusne metode z uporabo laboratorijskih naprav za paro nizke temperature in formaldehid so zajete v standardu ISO 11138-5:2017.
Oprema za preskušanje kemijskih indikatorjev tipa 2 (npr. Bowie Dick) je določena v standardih ISO 11140-3:2007, ISO 11140-4:2007 in ISO 11140-5:2007.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2018
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SIST EN ISO 18472:2006
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Sterilization of health care products - Biological and chemical indicators - Test equipment
(ISO 18472:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische und chemische
Indikatoren - Prüfausrüstung (ISO 18472:2018)
Stérilisation des produits de santé - Indicateurs biologiques et chimiques - Appareillage
d'essai (ISO 18472:2018)
Ta slovenski standard je istoveten z: EN ISO 18472:2018
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.
EN ISO 18472
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2018
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 18472:2006
English Version
Sterilization of health care products - Biological and
chemical indicators - Test equipment (ISO 18472:2018)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques et chimiques - Appareillage d'essai (ISO Gesundheitsfürsorge - Biologische und chemische
18472:2018) Indikatoren - Prüfausrüstung (ISO 18472:2018)
This European Standard was approved by CEN on 9 May 2018.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18472:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18472:2018) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” 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 2019, and conflicting national standards shall
be withdrawn at the latest by March 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18472:2006.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 18472:2018 has been approved by CEN as EN ISO 18472:2018 without any modification.
INTERNATIONAL ISO
STANDARD 18472
Second edition
2018-08
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 18472:2018(E)
©
ISO 2018
ISO 18472:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
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ii © ISO 2018 – All rights reserved
ISO 18472:2018(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 Test methods . 4
4.3 Air leakage test. 4
4.4 Steam resistometer performance requirements . 5
4.4.1 Measurement accuracy . 5
4.4.2 Data . 5
4.4.3 Process control . 5
4.4.4 General steam resistometer requirements . 6
4.4.5 Air leakage test . 7
4.4.6 Operation of steam resistometer . 7
4.5 Ethylene oxide gas resistometer performance requirements . 7
4.5.1 Measurement accuracy . 7
4.5.2 Data . 8
4.5.3 Process control . 8
4.5.4 General ethylene oxide gas resistometer requirements . 9
4.5.5 Air leakage test .10
4.5.6 Operation of ethylene oxide gas resistometer .10
4.6 Dry heat (heated air) resistometer performance requirements .10
4.6.1 Measurement accuracy .10
4.6.2 Data .11
4.6.3 Process control .11
4.6.4 General dry heat (heated air) resistometer requirements .12
4.6.5 Operation of dry heat (heated air) resistometer .12
4.7 Vaporized hydrogen peroxide resistometer performance requirements .13
4.7.1 Measurement accuracy .13
4.7.2 Recording interval .13
4.7.3 Process control .13
4.7.4 General vaporized hydrogen peroxide resistometer requirements .14
4.7.5 Air leakage test .15
4.7.6 Operation of vaporized hydrogen peroxide resistometer .15
5 Calibration .15
Annex A (informative) Additional performance characterization — Steam .16
Annex B (informative) Additional performance characterization — Ethylene oxide gas .19
Annex C (informative) Additional performance characterization — Dry heat.22
Annex D (informative) Resistometer documentation and derivations .24
Bibliography .30
ISO 18472:2018(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will b
...
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