EN ISO 11140-3:2009

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3: Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007, einschließlich Cor 1:2007)

Dieser Teil von ISO 11140 legt die Anforderungen an chemische Indikatoren fest, die beim Dampfdurchdringungsversuch
für Dampfsterilisatoren für verpacktes Sterilisiergut, z. B. Instrumente und poröse Materialien,
verwendet werden sollen. Der Indikator für diesen Zweck ist ein Indikator der Klasse 2, wie er in ISO 11140-1
beschrieben wird.
Diesem Teil von ISO 11140 entsprechende Indikatoren sind zur Verwendung in Kombination mit dem Norm-
Prüfpaket, wie es in EN 285 beschrieben ist, vorgesehen. Dieser Teil von ISO 11140 berücksichtigt nicht die
Leistungsfähigkeit des Norm-Prüfpakets, sondern legt die Leistungsfähigkeit der Indikatorsysteme fest.

Stérilisation des produits de santé - Indicateurs chimiques - Partie 3: Systèmes d'indicateurs de Classe 2 pour utilisation lors de l'essai de Bowie et Dick de pénétration de la vapeur (ISO 11140-3:2007, Cor 1:2007 inclus)

L'ISO 11140-3:2007 spécifie les exigences relatives aux indicateurs chimiques destinés à être utilisés dans l'essai de pénétration de la vapeur pour les produits emballés, par exemple les instruments et les matériaux poreux. L'indicateur prévu dans ce but est un indicateur de Classe 2, tel que décrit dans l'ISO 11140-1.
Les indicateurs conformes à l'ISO 11140-3:2007 sont destinés à être utilisés en association avec l'emballage d'essai normalisé tel que décrit dans l'EN 285. L'ISO 11140-3:2007 ne prend pas en compte la performance de cet emballage, mais spécifie la performance des indicateurs.

Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 3. del: Sistemi indikatorjev razreda 2 za uporabo pri Bowie-Dickovem preskusu prodiranja pare (ISO 11140-3:2007)

General Information

• Status: Published
• Publication Date: 05-May-2009
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 7 - Biological and chemical indicators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-May-2009
• Completion Date: 06-May-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 11140-3:2009 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)

Relations

• Replaces: EN ISO 11140-3:2007 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
• Effective Date: 13-May-2009
• Replaces: EN ISO 11140-3:2007/AC:2008 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
• Effective Date: 13-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11140-3:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 11140-3:2007
SIST EN ISO 11140-3:2007/AC:2008
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 3. del: Sistemi
indikatorjev razreda 2 za uporabo pri Bowie-Dickovem preskusu prodiranja pare
(ISO 11140-3:2007)
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator
systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3:
Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest
(ISO 11140-3:2007)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 3: Systèmes
d'indicateurs de Classe 2 pour utilisation lors de l'essai de Bowie et Dick de pénétration
de la vapeur (ISO 11140-3:2007)
Ta slovenski standard je istoveten z: EN ISO 11140-3:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-3:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11140-3:2009

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SIST EN ISO 11140-3:2009
EUROPEAN STANDARD
EN ISO 11140-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.01 Supersedes EN ISO 11140-3:2007
English Version
Sterilization of health care products - Chemical indicators - Part
3: Class 2 indicator systems for use in the Bowie and Dick-type
steam penetration test (ISO 11140-3:2007, including Cor
1:2007)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 3: Systèmes d'indicateurs de Classe 2 pour Chemische Indikatoren - Teil 3: Indikatorsysteme der
utilisation lors de l'essai de Bowie et Dick de pénétration de Klasse 2 zur Verwendung im Bowie-Dick-
la vapeur (ISO 11140-3:2007, Cor 1:2007 inclus) Dampfdurchdringungstest (ISO 11140-3:2007,
einschließlich Cor 1:2007)
This European Standard was approved by CEN on 19 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-3:2009: E
worldwide for CEN national Members.

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SIST EN ISO 11140-3:2009
EN ISO 11140-3:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 11140-3:2009
EN ISO 11140-3:2009 (E)
Foreword
The text of ISO 11140-3:2007, including Cor 1:2007 has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO 11140-3:2009 by 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 11140-3
...