EN ISO 11138-3:2017
(Main)Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.
NOTE 2 National or regional regulations can provide requirements for work place safety.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3: Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017)
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 Sterilisationsverfahren vorgesehen sind, die feuchte Hitze als sterilisierendes Agens anwenden.
ANMERKUNG 1 Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit feuchter Hitze sind in ISO 17665 angegeben.
ANMERKUNG 2 Anforderungen an die Sicherheit am Arbeitsplatz können in nationalen oder regionalen Bestimmungen angegeben sein.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la stérilisation à la chaleur humide (ISO 11138-3:2017)
ISO 11138-3:2017 spécifie des exigences pour les organismes d'essai, les suspensions, les porte-germes inoculés, les indicateurs biologiques et les méthodes d'essai utilisés dans l'évaluation des performances des procédés de stérilisation qui emploient la chaleur humide comme agent stérilisant.
NOTE 1 Les exigences de validation et de contrôle des procédés de stérilisation par chaleur humide sont fournies par l'ISO 17665.
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 - 3. del: Biološki indikatorji za sterilizacijske postopke z vlažno toploto (ISO 11138-3:2017)
Ta dokument določa zahteve za preskusne organizme, suspenzije, vcepljene prenašalce in biološke indikatorje ter preskusne metode za uporabo pri vrednotenju učinkovitosti sterilizacijskih postopkov, ki kot sterilizacijsko sredstvo uporabljajo vlažno toploto.
OPOMBA 1: zahteve za potrjevanje in nadzor sterilizacijskih postopkov z vlažno toploto zagotavlja skupina standardov ISO 17665.
OPOMBA 2: zahteve za varnost na delovnem mestu lahko zagotavljajo nacionalni ali regionalni predpisi.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11138-3:2017
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-3:2009
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 3. del: Biološki
indikatorji za sterilizacijske postopke z vlažno toploto (ISO 11138-3:2017)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators
for moist heat sterilization processes (ISO 11138-3:2017)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs
biologiques pour la stérilisation à la chaleur humide (ISO 11138-3:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3:
Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-3:2017
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11138-3:2017
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SIST EN ISO 11138-3:2017
EN ISO 11138-3
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-3:2009
English Version
Sterilization of health care products - Biological indicators
- Part 3: Biological indicators for moist heat sterilization
processes (ISO 11138-3:2017)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 3: Indicateurs biologiques pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 3:
stérilisation à la chaleur humide (ISO 11138-3:2017) Biologische Indikatoren für Sterilisationsverfahren mit
feuchter Hitze (ISO 11138-3:2017)
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 11138-3:2017 E
worldwide for CEN national Members.
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SIST EN ISO 11138-3:2017
EN ISO 11138-3:2017 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11138-3:2017
EN ISO 11138-3:2017 (E)
European foreword
This document (EN ISO 11138-3:2017) 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 11138-3:2009.
The standard is a full technical revision of the previous version. The following amendments have been
made in comparison with EN ISO 11138-3:2009:
— requirements on population and resistance (clause 9) revised;
— Annex A, in particular A.2.4 step 4 revised;
— informative Annex ZA respective relationship between this European Standard and the essential
requirements of Directive 9
...
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