EN ISO 11140-1:2009

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

ISO 11140-1:2005 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2005)

1.1 Dieser Teil von ISO 11140 legt allgemeine Anforderungen und Prüfverfahren für Indikatoren fest, die
deren Exposition gegenüber Sterilisationsverfahren durch physikalische und/oder chemische Veränderungen
von Substanzen sichtbar machen und die dazu verwendet werden, um die Erreichung einer oder mehrerer
Variablen zu überwachen, die für ein Sterilisationsverfahren erforderlich sind. Sie sind in ihrer Wirkung vom
Vorhandensein oder der Abwesenheit eines lebenden Organismus unabhängig.
ANMERKUNG Als biologische Prüfsysteme werden diejenigen Prüfungen angesehen, die für ihre Auswertung vom
Nachweis der Lebensfähigkeit eines Organismus abhängig sind. Prüfsysteme dieser Art werden in der Normenreihe
ISO 11138 für biologische Indikatoren (BI) behandelt.
1.2 Die Anforderungen und Prüfverfahren dieses Teils von ISO 11140 gelten für alle Indikatoren, die in
nachfolgenden Teilen von ISO 11140 festgelegt werden, außer wenn die Anforderung in einem nachfolgenden
Teil abgeändert oder hinzugefügt wird; in diesem Fall gilt die Anforderung dieses besonderen Teils.
Die einschlägigen Prüfgeräte werden in ISO 18472 beschrieben.
ANMERKUNG Zusätzliche Anforderungen für spezifische Prüfindikatoren (Indikatoren der Klasse 2) sind in ISO 11140-3,
ISO 11140-4 und ISO 11140-5 angegeben.

Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales (ISO 11140-1:2005)

L'ISO 11140-1:2005 spécifie les exigences générales et les modes opératoires d'essai relatifs aux indicateurs exposés à des procédés de stérilisation par modification des substances de nature physique et/ou chimique, qui sont utilisés pour contrôler l'acquisition d'un ou plusieurs paramètre(s) requis pour un procédé de stérilisation. Ils ne dépendent pas de leur action en présence ou en l'absence d'un organisme vivant.
Les exigences et les méthodes d'essai de la présente partie de l'ISO 11140 s'appliquent à tous les indicateurs spécifiés dans les parties suivantes de l'ISO 11140, sauf en cas de modification de l'exigence ou ajout de celle-ci dans une partie suivante, auquel cas l'exigence de cette partie spécifique s'appliquera.

Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne zahteve (ISO 11140-1:2005)

General Information

• Status: Withdrawn
• Publication Date: 05-May-2009
• Withdrawal Date: 11-Nov-2014
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 12-Nov-2014
• 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: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 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
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 11140-1:2009 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

Relations

• Replaces: EN ISO 11140-1:2005 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 11140-1:2014 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
• Effective Date: 13-Nov-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11140-1:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 11140-1:2005
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne
zahteve (ISO 11140-1:2005)
Sterilization of health care products - Chemical indicators - Part 1: General requirements
(ISO 11140-1:2005)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1:
Allgemeine Anforderungen (ISO 11140-1:2005)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences
générales (ISO 11140-1:2005)
Ta slovenski standard je istoveten z: EN ISO 11140-1:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11140-1:2009

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SIST EN ISO 11140-1:2009
EUROPEAN STANDARD
EN ISO 11140-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.01 Supersedes EN ISO 11140-1:2005
English Version
Sterilization of health care products - Chemical indicators - Part
1: General requirements (ISO 11140-1:2005)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences générales (ISO 11140-1:2005) Chemische Indikatoren - Teil 1: Allgemeine Anforderungen
(ISO 11140-1:2005)
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 11140-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 11140-1:2009
EN ISO 11140-1:2009 (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 11140-1:2009
EN ISO 11140-1:2009 (E)
Foreword
The text of ISO 11140-1:2005 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
11140-1:2009 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 11140-1:2005.
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 EC Directive.
For relationship with EC Directive, 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, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxe
...