Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

ISO 11140-1:2014 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 process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2014)

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 verwendet werden, um das Erreichen eines oder mehrerer Verfahrensparameter(s), (der) die für ein Sterilisationsverfahren festgelegt sind (ist), zu überwachen. Sie sind in ihrer Wirkung vom Vorhandensein oder der Abwesenheit eines lebenden Organismus unabhängig.
ANMERKUNG 1 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.
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 nach-folgenden Teil abgeändert oder diesem hinzugefügt wird; in diesem Fall gilt die Anforderung dieses besonderen Teils.
Die einschlägigen Prüfgeräte werden in ISO 18472 beschrieben.
ANMERKUNG 2 Zusätzliche Anforderungen für spezifische Prüfindikatoren/Indikatorsysteme (Indikatoren des Typs 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 11140-1:2014)

L'ISO 11140-1:2014 spécifie les exigences générales et les méthodes d'essai relatives aux indicateurs qui révèlent l'exposition à des procédés de stérilisation par modification physique et/ou chimique de substances, et qui sont utilisés pour contrôler l'obtention d'un ou de plusieurs paramètres spécifiés pour un procédé de stérilisation. Leur action ne dépend pas de la présence ou de l'absence d'un organisme vivant.

Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne zahteve (ISO 11140-1:2014)

Ta del standarda ISO 11140 določa splošne zahteve in preskusne metode za indikatorje, ki kažejo izpostavljenost sterilizacijskim postopkom s fizično in/ali kemično spremembo snovi ter se uporabljajo za spremljanje doseganja parametra(-ov) postopka za sterilizacijski postopek. Njihovo delovanje ni odvisno prisotnosti ali odsotnosti živega organizma.
OPOMBA 1 Biološki preskuševalni sistemi se obravnavajo kot sistemi, katerih interpretacija je odvisna od sposobnosti organizma za življenje. Preskuševalni sistemi te vrste so obravnavani v standardih ISO 11138 za biološke indikatorje (BI).
Zahteve in preskusne metode iz tega dela standarda ISO 11140 veljajo za vse indikatorje, določene v
nadaljnjih delih standarda ISO 11140, razen če je zahteva v enem od nadaljnjih delov spremenjena ali dodana, pri čemer v takem primeru velja zahteva iz zadevnega dela.
Zadevna preskusna oprema je opisana v standardu ISO 18472.
OPOMBA 2 Dodatne zahteve za posebne preskusne indikatorje/sisteme indikatorjev (indikatorji vrste 2) so navedene v standardih ISO 11140-3, ISO 11140-4 in ISO 11140-5.

General Information

Status
Published
Publication Date
11-Nov-2014
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
12-Nov-2014
Completion Date
12-Nov-2014

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SLOVENSKI STANDARD
SIST EN ISO 11140-1:2015
01-marec-2015
1DGRPHãþD
SIST EN ISO 11140-1:2009

Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne

zahteve (ISO 11140-1:2014)

Sterilization of health care products - Chemical indicators - Part 1: General requirements

(ISO 11140-1:2014)

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1:

Allgemeine Anforderungen (ISO 11140-1:2014)

Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences

générales (ISO 11140-1:2014)
Ta slovenski standard je istoveten z: EN ISO 11140-1:2014
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-1:2015 en

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

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SIST EN ISO 11140-1:2015
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SIST EN ISO 11140-1:2015
EUROPEAN STANDARD
EN ISO 11140-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2014
ICS 11.080.01 Supersedes EN ISO 11140-1:2009
English Version
Sterilization of health care products - Chemical indicators - Part
1: General requirements (ISO 11140-1:2014)

Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -

Partie 1: Exigences générales (ISO 11140-1:2014) Chemische Indikatoren - Teil 1: Allgemeine Anforderungen

(ISO 11140-1:2014)
This European Standard was approved by CEN on 23 August 2014.

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-CENELEC 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-CENELEC Management Centre has the same

status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United

Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-1:2014 E

worldwide for CEN national Members.
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SIST EN ISO 11140-1:2015
EN ISO 11140-1:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EC on medical devices ...........................................................4

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SIST EN ISO 11140-1:2015
EN ISO 11140-1:2014 (E)
Foreword

This document (EN ISO 11140-1:2014) 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 May 2015, and conflicting national standards shall be withdrawn at the

latest by May 2015.

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 11140-1:2009.

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, Bulgaria, Croatia, Cyprus, Czech

Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification.

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SIST EN ISO 11140-1:2015
EN ISO 11140-1:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EC on medical devices

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/EC on medical devices.

Once this standard is cited in the Official Journal of the European Union 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.1 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.1 — Correspondence between this European Standard and Directive 93/42/EC

on medical devices

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes

prEN ISO 11140-1 of Directive 93/42/EC
7.2
5.9 release of toxic substances
6.2.2 transfer type 1
6.4.2 transfer type. 3 – 6
7.2 test procedure
5.8 g) 7.3, 1 part Interfering substances
5.8 h) Safety precautions required
during and/or after use
6.2.2 Bleed and offset
4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator
5.8 13.1 Instructions for use
5.6, 5.7 13.2 Symbols
5.4, 5.6, 5.7, 5.8 i), 5.8 k) 13.3 a), b) Labelling
4 Classification of indicators
5.2 Critical variables and stated
values
5.8 j) 13.3 c) Labelling
5.4, 5.6, 5.7, 5.8 i), 5.8 k) 13.3 d) Labelling
4 Classification of indicators
5.2 Critical variables and stated
values
5.8 j) 13.3 e), f), g), h) Labelling, expiry date.
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SIST EN ISO 11140-1:2015
EN ISO 11140-1:2014 (E)

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes

prEN ISO 11140-1 of Directive 93/42/EC
5.8 e) 13.3 i) Storage
5.8 g) Interfering substances
5.8 13.3 j) Instructions for use
5.8 h) 13.3 k) Safety precautions
5.4, 5.6, 5.7, 5.8 i), 5.8 k) 13.3 l) Labelling
4 Classification of indicators
5.2 Critical variables and stated
values
5.8 j) 13.3 m), n) Labelling
5.4 13.4 Marking
5.8 13.6 a) Marking
5.8 13.6 b) Marking
5.8 h) 13.6 e) Instructions after use
5.9 Toxicity declaration
5.8 g) 13.6 f) Interfering substances
5.8 h) 13.6 g), h), j), k), l), m), n), o), p) Instructions after use
5.9 Toxicity declaration

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.
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SIST EN ISO 11140-1:2015
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SIST EN ISO 11140-1:2015
INTERNATIONAL ISO
STANDARD 11140-1
Third edition
2014-11-01
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 11140-1:2014(E)
ISO 2014
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Categorization ......................................................................................................................................................................................................... 4

4.1 General ........................................................................................................................................................................................................... 4

4.2 Type 1: process indicators ............................................................................................................................................................ 4

4.3 Type 2: indicators for use in specific tests ...................................................................................................................... 5

4.4 Type 3: single critical process variable indicators ................................................................................................... 5

4.5 Type 4: multicritical process variable indicators ...................................................................................................... 5

4.6 Type 5: integrating indicators .................................................................................................................................................... 5

4.7 Type 6: emulating indicators ...................................................................................................................................................... 5

5 General requirements ..................................................................................................................................................................................... 5

6 Performance requirements ....................................................................................................................................................................... 8

6.1 General ........................................................................................................................................................................................................... 8

6.2 Type 1 indicators................................................................................................................................................................................... 9

6.3 Type 2 indicators................................................................................................................................................................................... 9

6.4 Types 3, 4, 5 and 6 indicators ..................................................................................................................................................... 9

7 Test methods ............................................................................................................................................................................................................. 9

7.1 General ........................................................................................................................................................................................................... 9

7.2 Off-set (transference) ........................................................................................................................................................................ 9

7.3 Procedure — Steam indicators ................................................................................................................................................. 9

7.4 Procedure — Dry heat indicators ........................................................................................................................................10

7.5 Procedure — EO indicators ......................................................................................................................................................10

7.6 Procedure — Low temperature steam and formaldehyde indicators..................................................11

7.7 Procedure — Vaporized hydrogen peroxide indicators ...................................................................................11

8 Additional requirements for process (Type 1) indicators .....................................................................................12

8.1 Process indicators printed or applied on to packaging material ..............................................................12

8.2 Process indicators for steam sterilization processes ..........................................................................................12

8.3 Process indicators for dry heat sterilization processes ....................................................................................12

8.4 Process indicators for ethylene oxide sterilization processes ....................................................................13

8.5 Process indicators for radiation sterilization processes ..................................................................................13

8.6 Process indicators for low temperature steam and formaldehyde

sterilization processes ...................................................................................................................................................................14

8.7 Process indicators for vaporized hydrogen peroxide sterilization processes...............................14

9 Additional requirements for single critical process variable (Type 3) indicators .......................15

10 Additional requirements for multicritical process variable (Type 4) indicators ..........................15

11 Additional requirements for steam integrating (Type 5) indicators ..........................................................16

12 Additional requirements for ethylene oxide integrating (Type 5) indicators ..................................17

13 Additional requirements for emulating (Type 6) indicators ..............................................................................17

Annex A (normative) Method for demonstrating shelf-life of the product ...............................................................19

Annex B (informative) Examples of testing indicators ...................................................................................................................20

Annex C (informative) Rationale for the requirements for integrating indicators and the link

to the requirements for biological indicators specified in ISO 11138 (all parts) and

microbial inactivation ..................................................................................................................................................................................22

Annex D (informative) Rationale for the liquid-phase test method for low temperature steam and

© ISO 2014 – All rights reserved iii
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(E)

formaldehyde indicators ...........................................................................................................................................................................29

Annex E (informative) Relationship of indicator and indicator system components ....................................30

Bibliography .............................................................................................................................................................................................................................31

iv © ISO 2014 – All rights reserved
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received. www.iso.org/patents

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers

to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 198, Sterilization of health care products.

This third edition cancels and replaces the second edition (ISO 11140-1:2005), 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 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
— Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 11140-2 has been withdrawn and replaced by ISO 18472.
© ISO 2014 – All rights reserved v
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(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,

low temperature steam and 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 and indicator systems) 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 validation and routine control, respectively.

This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general

requirements for chemical indicators. The categorization structure for chemical indicators is used solely

to denote the characteristics and intended use of each type of indicator when used as specified by the

manufacturer. This categorization has no hierarchical significance. The chemical indicators described

in this part of ISO 11140 are categorized into six types. The chemical indicators within each of these

categorizations are further subdivided by the sterilization process for which they are designed to be

used. This part of ISO 11140 defines the requirements for Type 1 and Types 3 to 6. In subsequent parts

of ISO 11140, the requirements for Type 2 indicators are categorized by their intended use. The use of

the indicators and indicator systems, specified in this part of ISO 11140, is described in for example the

ISO 11135, the ISO 17665- series, ISO 15882, EN 285, and EN 13060.

Resistometers are used to characterize the performance of the chemical indicators described in this part

of ISO 11140, with the exception of Type 2 indicators. Requirements for resistometers are specified in

ISO 18472. Resistometers differ from sterilizers. As sterilizers cannot duplicate resistometer conditions

they should not be used to test the performance of chemical indicators. Sterilizers from different

manufacturers and of different ages have significantly different cycle profiles; for example, prolonged

preconditioning phases. Resistometers allow for precise control of the specific test cycle sequences in

order to study the effect of process parameters on indicator performance under controlled, repeatable

conditions. Guidance on the selection, use and interpretation of the results of chemical indicators is given

in ISO 15882. Users of chemical indicators are expected to make reference to this part of ISO 11140.

vi © ISO 2014 – All rights reserved
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SIST EN ISO 11140-1:2015
INTERNATIONAL STANDARD ISO 11140-1:2014(E)
Sterilization of health care products — Chemical
indicators —
Part 1:
General requirements

WARNING — The use of this part of ISO 11140 can involve hazardous materials, operations

and equipment. This part of ISO 11140 does not purport to address all of the safety problems

associated with their use. It is the responsibility of the user of this part of ISO 11140 to determine

the applicability of national or regional regulatory requirements and to establish appropriate

occupational health and safety practices prior to use of any hazardous materials, operations

and/or equipment.
1 Scope

This part of ISO 11140 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 process parameter(s) specified for a sterilization

process. They are not dependent for their action on the presence or absence of a living organism.

NOTE 1 Biological test systems are regarded as those test systems which are dependent for their interpretation

on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138-

series for biological indicators (BIs).

The requirements and test methods of this part of ISO 11140 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.
Relevant test equipment is described in ISO 18472.

NOTE 2 Additional requirements for specific test indicators/indicator systems (Type 2 indicators) are given in

ISO 11140-3, ISO 11140-4 and ISO 11140-5.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 8601:2004, Data elements and interchange formats — Information interchange — Representation of

dates and times

ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1:2006, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11137-2:2013, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization

dose

ISO 11137-3:2006, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric

aspects
© ISO 2014 – All rights reserved 1
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(E)

ISO 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General

requirements

ISO 11138-2:2006, Sterilization of health care products — Biological indicators — Part 2: Biological

indicators for ethylene oxide sterilization processes

ISO 11138-3:2006, Sterilization of health care products — Biological indicators — Part 3: Biological

indicators for moist heat sterilization processes

ISO 11138-4:2006, Sterilization of health care products — Biological indicators — Part 4: Biological

indicators for dry heat sterilization processes

ISO 11138-5:2006, Sterilization of health care products — Biological indicators — Part 5: Biological

indicators for low-temperature steam and formaldehyde sterilization processes

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 11140-4:2007, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators

as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO 11140-5:2007, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators

for Bowie and Dick-type air removal tests

ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the

development, validation and routine control of a sterilization process for medical devices

ISO/TS 17665-2:2009, Sterilization of health care products — Moist heat — Part 2: Guidance on the

application of ISO 17665-1

ISO/TS 17665-3:2013, Sterilization of health care products — Moist heat — Part 3: Guidance on the

designation of a medical device to a product family and processing category for steam sterilization

ISO 18472:2006, Sterilization of health care products — Biological and chemical indicators — Test

equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
bleed

unintentional lateral migration of the indicator agent beyond the margins within which the indicator

agent was applied
3.2
critical process variable

variable identified as being essential to the attainment of sterilization and monitored by the chemical

indicator
3.3
endpoint

point of the observed change defined by the manufacturer, occurring after the indicator has been

exposed to specified stated values
3.4
exposure period
time from the attainment of the specified exposure conditions to its termination
2 © ISO 2014 – All rights reserved
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SIST EN ISO 11140-1:2015
ISO 11140-1:2014(E)
3.5
graduated response

progressive observable change occurring on exposure to one or more critical process variables allowing

assessment of the level achieved
3.6
indicator

combination of the indicator agent and its substrate that reveals change in one or more process variables

based on a chemical or physical change resulting from exposure to a process

Note 1 to entry: An indicator intended to be used only in combination with a specific test load is also termed an

indicator (both together becoming an indicator system).
Note 2 to entry: See Annex
...

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