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)

20070214 - At Publication stage please update Foreword as requested by CEN/TC 102 (see network)

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

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)

La présente partie de l’ISO 11140 spécifie les exigences relatives aux indicateurs chimiques destinés à être utilisés dans l'essai de pénétration de la vapeur pour les produits emballés, par ex. les instruments et matériaux poreux. L’indicateur prévu dans ce but est un indicateur de classe 2, tel que décrit dans l’ISO 111401-1.
Les indicateurs conformes à la présente partie de l’ISO 11140 sont destinés à être utilisés en association avec l’emballage d’essai normalisé tel que décrit dans l’EN 285. La présente partie de l’ISO 11140 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• Status: Withdrawn
• Publication Date: 14-Mar-2007
• Withdrawal Date: 05-May-2009
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-May-2009
• Completion Date: 06-May-2009
• 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 11140-3:2007 - 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)

Relations

• Replaces: EN 867-3:1997/AC:1998 - Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test
• Effective Date: 22-Dec-2008
• Replaces: EN 867-3:1997 - Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test
• Effective Date: 22-Dec-2008
• Replaced By: 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)
• Effective Date: 13-May-2009
• Corrected By: 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11140-3:2007
01-september-2007
1DGRPHãþD
SIST EN 867-3:2000
SIST EN 867-3:2000/AC:2000
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: Systemes
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 11140-3:2007
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-3:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11140-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2007
ICS 11.080.01 Supersedes EN 867-3:1997
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)
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) Dampfdurchdringungstest (ISO 11140-3:2007)
This European Standard was approved by CEN on 14 March 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-3:2007: E
worldwide for CEN national Members.

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EN ISO 11140-3:2007 (E)

Foreword

This document (EN ISO 11140-3:2007) 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 September 2007, and conflicting
national standards shall be withdrawn at the latest by September 2007.

This document supersedes EN 867-3:1997.

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).

The series EN ISO 11140 consists of the following parts under the general title Sterilization of
health care products - Chemical indicators:

 Part 1: General requirements
 Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration
test
 Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of
steam penetration.

Attention is drawn to the fact that the series ISO 11140 additionally consists of Part 5: Class 2
indicators for Bowie and Dick-type air removal tests. However, this Part of ISO 11140 will not
be part of the series EN ISO 11140 because CEN/TC 102 decided not to adopt ISO 11140-5
as a European Standard.

In addition, reference is made to EN 867-5 Non-biological systems for use in sterilizers -
Part 5: Specification for indicator systems and proc
...