EN ISO 11140-1:2009

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11140-1:2005 has been approved by CEN as a EN ISO 11140-1:2009 without any
modification.
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 on medical devices.
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 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.

Table ZA – Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4.2 to 4.7 8, 7
5.5 5
5.8 13 [except 13.3 a) and 13.6 q)] The relevant Essential
Requirement 13.3 a) is
partly addressed.
The relevant Essential
Requirement 13.6 q) is not
addressed in this European
Standard
6.1 10.1
8 10.1
WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the
scope of the 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 fo
...