Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1       Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2       National or regional regulations can provide requirements for work place safety.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2017)

Dieses Dokument legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung von Sterilisatoren und Sterilisationsverfahren vorgesehen sind, die Ethylenoxidgas als sterilisierendes Agens verwenden, entweder als reines Ethylenoxidgas oder als Gemische dieses Gases mit Verdünnungsgasen bei Sterilisiertemperaturen im Bereich von 29 °C bis 65 °C.
ANMERKUNG 1   Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit Ethylenoxid sind in ISO 11135 und ISO 14937 angegeben.
ANMERKUNG 2   Anforderungen an die Sicherheit am Arbeitsplatz könnten in nationalen oder regionalen Bestimmungen angegeben sein.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2017)

ISO 11138-2:2017 spécifie les exigences spécifiques applicables aux organismes d'essai, aux suspensions, aux porte-germes inoculés, aux indicateurs biologiques et aux méthodes d'essai prévus pour être utilisés dans l'évaluation des performances des stérilisateurs et des procédés de stérilisation qui ont recours à l'oxyde d'éthylène comme agent stérilisant, soit sous forme d'oxyde d'éthylène pur soit sous forme de mélanges de ce gaz et de gaz diluants, à des températures de stérilisation comprises entre 29 °C et 65 °C.
NOTE 1       Les exigences de validation et de contrôle des procédés de stérilisation à l'oxyde d'éthylène sont fournies par l'ISO 11135 et l'ISO 14937.
NOTE 2       Des réglementations nationales ou régionales peuvent fournir des exigences relatives à la sécurité du lieu de travail.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2017)

Ta dokument določa zahteve za preskusne organizme, suspenzije, vcepljene prenašalce in biološke indikatorje ter preskusne metode za uporabo pri vrednotenju učinkovitosti sterilizatorjev in sterilizacijskih postopkov, ki kot sterilizacijsko sredstvo uporabljajo etilenoksidov plin, ali kot čisti etilenoksidov plin ali mešanice tega plina in plinov za redčenje, pri temperaturah za sterilizacijo v razponu od 29 °C do 65 °C.
OPOMBA 1: zahteve za potrjevanje in nadzor sterilizacijskih postopkov z etilenoksidom zagotavljata standarda ISO 11135 in ISO 14937.
OPOMBA 2: zahteve za varnost na delovnem mestu lahko zagotavljajo nacionalni ali regionalni predpisi.

General Information

Status
Published
Publication Date
28-Mar-2017
Withdrawal Date
29-Sep-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
29-Mar-2017
Completion Date
29-Mar-2017

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SLOVENSKI STANDARD
SIST EN ISO 11138-2:2017
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-2:2009
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki
indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2017)
Sterilization of health care products - Biological indicators - Part 2: Biological indicators
for ethylene oxide sterilization processes (ISO 11138-2:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2:
Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2017)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs
biologiques pour la stérilisation à l'oxyde d'éthylène (ISO 11138-2:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-2:2017
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-2:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11138-2:2017

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SIST EN ISO 11138-2:2017


EN ISO 11138-2
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-2:2009
English Version

Sterilization of health care products - Biological indicators
- Part 2: Biological indicators for ethylene oxide
sterilization processes (ISO 11138-2:2017)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 2: Indicateurs biologiques pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 2:
stérilisation à l'oxyde d'éthylène (ISO 11138-2:2017) Biologische Indikatoren für Sterilisationsverfahren mit
Ethylenoxid (ISO 11138-2:2017)
This European Standard was approved by CEN on 19 January 2017.

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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-2:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11138-2:2017
EN ISO 11138-2:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11138-2:2017
EN ISO 11138-2:2017 (E)
European foreword
This document (EN ISO 11138-2:2017) 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 September 2017 and conflicting national standards
shall be withdrawn at the latest by September 2017.
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 11138-2:2009.
The standard is a full technical revision of the previous version. The following amendments have been
made in comparison with EN ISO 11138-2:2009:
— requirements on population and resistance (clause 9) revised, e.g. information to minimum D-value
at 30 °C deleted;
— Annex A, in particular A.2.4 step 6 revised;
— informative Annex B on rationale for the inclusion of a second D
...

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