SIST EN ISO 11138-2:2006
(Main)Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
This part of ISO 11138 provides specific 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.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)
Dieser Teil von ISO 11138 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 Sterilisiermittel 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 festgelegt.
ANMERKUNG 2 Anforderungen an die Sicherheit am Arbeitsplatz könnten in nationalen oder regionalen Bestimmungen festgelegt sein.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la stérilisation a l'oxyde d'éthylene (ISO 11138-2:2006)
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11138-2:2006
01-oktober-2006
1DGRPHãþD
SIST EN 866-2:2000
SIST EN 866-2:2000/AC:2000
SIST EN 866-8:2000
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 2. del: Biološki
indikatorji za sterilizacijske postopke z etilenoksidom (ISO 11138-2:2006)
Sterilization of health care products - Biological indicators - Part 2: Biological indicators
for ethylene oxide sterilization processes (ISO 11138-2:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2:
Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs
biologiques pour la stérilisation a l'oxyde d'éthylene (ISO 11138-2:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-2:2006
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-2:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 11138-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.080.01 Supersedes EN 866-2:1997, EN 866-8:1999
English Version
Sterilization of health care products - Biological indicators - Part
2: Biological indicators for ethylene oxide sterilization processes
(ISO 11138-2:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Partie 2: Indicateurs biologiques pour la stérilisation à Biologische Indikatoren - Teil 2: Biologische Indikatoren für
l'oxyde d'éthylène (ISO 11138-2:2006) Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2006)
This European Standard was approved by CEN on 7 June 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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 11138-2:2006: E
worldwide for CEN national Members.
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EN ISO 11138-2:2006 (E)
Foreword
This document (EN ISO 11138-2:2006) 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 January 2007, and conflicting national standards
shall be withdrawn at the latest by January 2007.
This document supersedes EN 866-2:1997, EN 866-8:1999.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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 11138-2:2006 has been approved by CEN as EN ISO 11138-2:2006 without any
modifications.
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EN ISO 11138-2:2006 (E)
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices: General.
Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this standard confers, within the limits of the scope of this standard, a
presumption of conformity with the relevant Essential Requirements of that Directive and
associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.
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INTERNATIONAL ISO
STANDARD 11138-2
Second edition
2006-07-01
Sterilization of health care products —
Biological indicators —
Part 2:
Biological indicators for ethylene oxide
sterilization processes
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 2: Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène
Reference number
ISO 11138-2:2006(E)
©
ISO 2006
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ISO 11138-2:2006(E)
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ISO 11138-2:2006(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 11138-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11138-2:1994), which has been technically
revised.
ISO 11138 consists of the following parts, under the general title Sterilization of health care products —
Biological indicators:
⎯ Part 1: General requirements
⎯ Part 2: Biological indicators for ethylene oxide sterilization processes
⎯ Part 3: Biological indicators for moist heat sterilization processes
⎯ Part 4: Biological indica
...
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