EN ISO 11140-1:2005

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

Enquiry under WI 00102058.

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)

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

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2005
• 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: 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 11140-1:2005 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

Relations

• Replaces: EN 867-2:1997 - Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
• Effective Date: 22-Dec-2008
• Replaces: EN 867-1:1997 - Non-biological systems for use in sterilizers - Part 1: General requirements
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11140-1:2009 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11140-1:2005
01-november-2005
1DGRPHãþD
SIST EN 867-1:2000
SIST EN 867-2:2000
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 11140-1:2005
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-1:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11140-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2005
ICS 11.080.01 Supersedes EN 867-1:1997, EN 867-2:1997
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 14 July 2005.
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, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-1:2005: E
worldwide for CEN national Members.

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EN ISO 11140-1:2005 (E)





Foreword


This document (EN ISO 11140-1:2005) 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 2006, and conflicting national
standards shall be withdrawn at the latest by January 2006.

This document supersedes EN 867-1:1997 and EN 867-2:1997.

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).

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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 11140-1:2005 has been approved by CEN as EN ISO 11140-1:2005 without any
modifications.

NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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EN ISO 11140-1:2005 (E)



Annex ZA
(normative)

Normative references to international publications
with their relevant European publications


This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when
...