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• Status: Withdrawn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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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).
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 incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).

NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.

Publication Year Title EN Year
ISO 8601 1988 Data elements and interchange EN 28601 1992
formats - Information interchange -
Representation of dates and times

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 a means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC.

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 given in Table ZA. confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding Essential
Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

INTERNATIONAL ISO
STANDARD 11140-1
Second edition
2005-07-15
Sterilization of health care products —
Chemical indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 1: Exigences générales
Reference number
ISO 11140-1:2005(E)
©
ISO 2005
ISO 11140-1:2005(E)
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ii © ISO 2005 – All rights reserved

ISO 11140-1:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Classification. 3
5 General requirements. 4
6 Performance requirements . 6
7 Test methods. 7
8 Additional requirements for process (Class 1) indicators . 10
9 Additional requirements for single variable (Class 3) indicators . 13
10 Additional requirements for multi-variable (Class 4) indicators. 13
11 Additional requirements for steam integrating (Class 5) indicators . 14
12 Additional requirements for dry heat integrating (Class 5) indicators . 14
13 Additional requirements for ethylene oxide integrating (Class 5) indicators . 15
14 Additional requirements for emulating (Class 6) indicators . 16
Annex A (informative) Method for demonstrating shelf life of the product . 17
Annex B (informative) Examples of testing indicators. 18
Annex C (informative) Rationale for the requirements for integrating indicators and the link to the
requirements for biological indicators (BIs) specified in ISO 11138 and microbial
inactivation . 19
Annex D (informative) Rationale for the liquid-phase test method for steam-formaldehyde
indicators. 25
Annex E (informative) Relationship of indicator components. 26
Bibliography . 27

ISO 11140-1:2005(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 11140-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11140-1:1995 and
ISO 11140-1:1995/Amd.1:1998), which has been technically revised.
ISO 11140 consists of the following parts, under the general title Sterilization of health care products —
Chemical indicators:
 Part 1: General requirements
 Part 2: Test equipment and methods
 Part 3: Class 2 indicators for steam penetration test sheets
 Part 4: Class 2 indicators for steam penetration test packs
 Part 5: Class 2 indicators for air removal test sheets and packs
NOTE ISO 11140-2 is to be replaced by ISO 18472, Sterilization of health care products — Biological and chemical
indicators — Test equipment.
iv © ISO 2005 – All rights reserved

ISO 11140-1:2005(E)
Introduction
This part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators
intended for use with sterilization processes employing steam, dry heat, ethylene oxide, γ or β radiation,
steam-formaldehyde or vaporized hydrogen peroxide.
Additional requirements for indicators intended for use with other sterilization methods (e.g. other forms of
moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general
requirements will apply.
The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of
ISO 11140.
Standards for sterilizers and for the validation and process control of sterilization, describe performance tests
for sterilizers and methods of va
...