SIST EN ISO 11135:2014

SLOVENSKI STANDARD
01-oktober-2014
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SIST EN ISO 11135-1:2007
SIST-TS CEN ISO/TS 11135-2:2008
SIST-TS CEN ISO/TS 11135-2:2008/AC:2009
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SULSRPRþNH,62
Sterilization of health-care products - Ethylene oxide - Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO 11135:2014)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 11135:2014)
Stérilisation des produits de santé - Oxyde d'éthylène - Exigences pour le
développement, la validation et la vérification de routine d'un processus de stérilisation
pour les appareils médicaux (ISO 11135:2014)
Ta slovenski standard je istoveten z: EN ISO 11135:2014
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 11135
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.080.01 Supersedes CEN ISO/TS 11135-2:2008, EN ISO 11135-
1:2007
English Version
Sterilization of health-care products - Ethylene oxide -
Requirements for the development, validation and routine control
of a sterilization process for medical devices (ISO 11135:2014)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Exigences de développement, de validation et de contrôle Ethylenoxid - Anforderungen an die Entwicklung,
de routine d'un processus de stérilisation pour des Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 11135:2014) Sterilisationsverfahrens für Medizinprodukte (ISO
11135:2014)
This European Standard was approved by CEN on 28 June 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 11135:2014 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 90/385/EEC .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC .5

Foreword
This document (EN ISO 11135:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of
health care products” in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices”
the secretariat of which is held by BSI.
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 2015, and conflicting national standards shall be withdrawn at
the latest by January 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 CEN ISO/TS 11135-2:2008, EN ISO 11135-1:2007.
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, ZB, which are integral parts 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 11135:2014 has been approved by CEN as EN ISO 11135:2014 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/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 one means of conforming to Essential Requirements of
the New Approach Directive 90/385/EEC.
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 relevant Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this
standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of 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 one 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 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 ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered
4,5,6,7,8,9,10,11,12 8.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 11135
Second edition
2014-07-15
Sterilization of health-care
products — Ethylene oxide —
Requirements for the development,
validation and routine control of
a sterilization process for medical
devices
Stérilisation des produits de santé — Oxyde d’éthylène — Exigences
de développement, de validation et de contrôle de routine d’un
processus de stérilisation pour des dispositifs médicaux
Reference number
ISO 11135:2014(E)
©
ISO 2014
ISO 11135:2014(E)
© 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
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11135:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Quality management systems .11
4.1 Documentation .11
4.2 Management responsibility .11
4.3 Product realization .11
4.4 Measurement, analysis and improvement — Control of nonconforming product .11
5 Sterilizing agent characterization .11
5.1 General .11
5.2 Sterilizing agent .12
5.3 Microbicidal effectiveness .12
5.4 Material effects.12
5.5 Safety and the environment .12
6 Process and equipment characterization .12
6.1 General .12
6.2 Process characterization .12
6.3 Equipment characterization .13
7 Product definition .14
7.1 General .14
7.2 Product safety, quality and performance .15
7.3 Microbiological quality .15
7.4 Documentation .15
8 Process definition .15
9 Validation .16
9.1 General .16
9.2 Installation qualification, IQ .17
9.3 Operational qualification, OQ .17
9.4 Performance qualification, PQ .18
9.5 Review and approval of validation .20
10 Routine monitoring and control .22
11 Product release from sterilization .23
12 Maintaining process effectiveness
..................................................................................................................................................23
12.1 General .23
12.2 Maintenance of equipment .24
12.3 Requalification .24
12.4 Assessment of change .24
12.5 Assessment of equivalence .25
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach .26
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach .27
Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers .29
ISO 11135:2014(E)
Annex D (informative) Guidance on the application of the normative requirements .32
Annex E (normative) Single Lot Release .74
Bibliography .76
iv © ISO 2014 – All rights reserved

ISO 11135:2014(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.
ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008, both of which have
been technically revised and condensed into a single standard.
ISO 11135:2014(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. Medical devices produced under
standard manufacturing conditions in accordance with the requirements for quality management
systems (see for example ISO 13485) might, prior to sterilization, have microorganisms on them, albeit
in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the
microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents
used to sterilize medical devices can generally best be described by an exponential relationship
between the numbers of microorganisms surviving and the extent of treatment with the ethylene
oxide (EO); inevitably this means that there is always a finite probability that a microorganism might
survive regardless of the extent of treatment applied. For a given treatment, the probability of survival
is determined by the number and resistance of microorganisms and by the environment in which the
organisms exist during treatment. It follows that the sterility of any one medical device in a population
subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is
defined in terms of the probability of there being a viable microorganism present on a medical device.
ISO 11135 describes requirements that, if met, will provide an ethylene oxide sterilization process
intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore,
compliance with the requirements ensures that validations conducted following this International
Standard will provide products that meet the defined requirements for sterile products with a high
degree of confidence. The specification for this probability is a matter for regulatory authorities and can
vary from country to country (see for example EN 556-1 and ANSI/AAMI ST67).
Generic requirements of the quality management systems for design and development, production,
installation and servicing are given in ISO 9001 and particular requirements for quality management
systems for medical device production are given in ISO 13485. The standards for quality management
systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness
of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization
is an example of such a process. For this reason, sterilization processes are validated for use, the
performance of the sterilization process monitored routinely and the equipment maintained.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor
associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable
for its intended use. Attention is therefore given to a number of considerations including:
— the microbiological status of incoming raw materials and/or components;
— the validation and routine control of any cleaning and disinfection procedures used on the product;
— the control of the environment in which the product is manufactured or reprocessed, assembled
and packaged;
— the control of equipment and processes;
— the control of personnel and their hygiene;
— the manner and materials in which the product is packaged;
— the conditions under which product is stored.
The type of contamination on a product to be sterilized varies and this impacts upon the effectiveness
of a sterilization process. Products that have been used in a health care setting and are being presented
for resterilization in accordance with the manufacturer’s instructions (see ISO 17664) are a special case.
There is the potential for such products to possess a wide range of contaminating microorganisms and
residual inorganic and/or organic contamination in spite of the application of a cleaning process. Hence,
it is important to pay particular attention to the validation and control of the cleaning and disinfection
processes used during reprocessing. Mixed product loads are common in health care facilities with
throughput volumes dictated by historical and predicted demand for sterile product.
vi © ISO 2014 – All rights reserved

ISO 11135:2014(E)
The requirements are the normative parts of ISO 11135 with which compliance is claimed. The guidance
given in the informative annexes is not normative and is not provided as a checklist for auditors. The
guidance in Annex D provides explanations and methods that are regarded as being suitable means for
complying with the requirements for industry and health care facilities.
The guidance, in Annex D, is intended for people who have a basic knowledge of the principles of EO
sterilization. Methods other than those given in the guidance can be used if they are effective in achieving
compliance with the requirements of ISO 11135.
The development, validation and routine control of a sterilization process comprises a number of
discrete but interrelated activities; e.g. calibration, maintenance, product definition, process definition,
installation qualification, operational qualification and performance qualification. While the activities
required by ISO 11135 have been grouped together and are presented in a particular order, ISO 11135
does not require that the activities be performed in the order in which they are presented. The activities
required are not necessarily sequential, as the programme of development and validation may be iterative.
It is possible that performing these different activities will involve a number of separate individuals
and/or organizations, each of whom undertakes one or more of these activities. This International
Standard does not specify the particular individuals or organizations to carry out the activities.
It is important that patient safety be addressed by minimizing exposure to EO and its by-products during
normal product use. ISO 10993-7 specifies limits for EO and ethylene chlorohydrin (ECH); however, no
exposure limits are set for ethylene glycol (EG) because risk assessment indicates that when EO residues
are controlled, it is unlikely that biologically significant residues of EG would be present.
INTERNATIONAL STANDARD ISO 11135:2014(E)
Sterilization of health-care products — Ethylene oxide —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
This International Standard specifies requirements for the development, validation and routine control
of an ethylene oxide sterilization process for medical devices in both the industrial and health care
facility settings, and it acknowledges the similarities and differences between the two applications.
NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety
measures. The major differences relate to the unique physical and organizational conditions in health care
facilities, and to the initial condition of reusable medical devices being presented for sterilization.
NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing
areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience.
The primary function of the health care facility is to provide patient care; medical device reprocessing is just one
of a myriad of activities that are performed to support that function.
NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize
large numbers of similar medical devices that have been produced from virgin material. Health care facilities,
on the other hand, must handle and process both new medical devices and reusable medical devices of different
descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of
cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International
Standard, alternative approaches and guidance specific to health care facilities are identified as such.
NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture-
sensitive medical devices that cannot be moist heat sterilized.
NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements
and provides guidance that can be applicable to other health care products.
1.2 Exclusions
1.2.1 This International Standard does not specify requirements for the development, validation and
routine control of a process for inactivating the causative agents of spongiform encephalopathies such
as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations
have been produced in particular countries for the processing of materials potentially contaminated with
these agents.
NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This International Standard does not detail a specified requirement for designating a medical
device as sterile.
NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”.
See for example EN 556–1 or ANSI/AAMI ST67.
1.2.3 This International Standard does not specify a quality management system for the control of all
stages of production of medical devices.
ISO 11135:2014(E)
NOTE The effective implementation of defined and documented procedures is necessary for the development,
validation and routine control of a sterilization process for medical devices. Such procedures are commonly
considered to be elements of a quality management system. It is not a requirement of this International Standard
to have a full quality management system during manufacture or reprocessing. The necessary elements are
normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the
standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing
of medical devices. National and/or regional regulations for the provision of medical devices might require the
implementation of a full quality management system and the assessment of that system by a third party.
1.2.4 This International Standard does not specify requirements for occupational safety associated
with the design and operation of EO sterilization facilities.
NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations
may also exist.
NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of
regulations giving safety requirements for handling EO and for premises in which it is used.
1.2.5 This International Standard does not cover sterilization by injecting EO or mixtures containing
EO directly into packages or a flexible chamber.
NOTE See ISO 14937 for these types of EO processes.
1.2.6 This International Standard does not cover analytical methods for determining levels of residual
EO and/or its reaction products.
NOTE 1 For further information see ISO 10993-7.
NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for
the level of EO residues present on or in medical devices.
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 10012, Measurement management systems — Requirements for measurement processes and measuring
equipment
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General
requirements
ISO 11138-2:2009, Sterilization of health care products — Biological indicators — Part 2: Biological
indicators for ethylene oxide sterilization processes
ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2003/Cor 1:2009, Medical devices — Quality management systems — Requirements for
regulatory purposes — Technical Corrigendum 1
2 © ISO 2014 – All rights reserved

ISO 11135:2014(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aeration
part of the sterilization process during which ethylene oxide and/or its reaction products desorb from
the medical device until predetermined levels are reached
Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room.
3.2
aeration area
either a chamber or a room in which aeration occurs
3.3
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO/TS 11139:2006, definition 2.2]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
[SOURCE: ISO/TS 11139:2006, definition 2.3]
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity
indicated by a measuring instrument or measuring system, or values represented by a material measure
or a reference material, and the corresponding values realized by standards
[SOURCE: ISO/TS 11139:2006, definition 2.4]
3.6
chemical indicator
test system that reveals a change in one or more pre-defined process variables based on a chemical or
physical change resulting from exposure to a process
[SOURCE: ISO/TS 11139:2006, definition 2.6]
3.7
conditioning
treatment of product within the sterilization cycle, but prior to ethylene oxide admission, to attain a
predetermined temperature and relative humidity
Note 1 to entry: This part of the sterilization cycle can be carried out either at atmospheric pressure or under
vacuum.
Note 2 to entry: See 3.27, preconditioning.
ISO 11135:2014(E)
3.8
D value
D value
time or dose required to achieve inactivation of 90 % of a population of the test microorganism under
stated conditions
[SOURCE: ISO/TS 11139:2006, definition 2.11]
Note 1 to entry: For the purposes of this International Standard, the D value is the exposure time required to
achieve 90 % inactivation of the population of the test organism.
3.9
development
act of elaborating a specification
[SOURCE: ISO/TS 11139:2006, definition 2.13]
3.10
dew point
The temperature at which the saturation water vapour pressure is equal to the partial pressure of the
water vapour in the atmosphere
Note 1 to entry: Any cooling of the atmosphere below the dew point would produce water condensation.
3.11
establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO/TS 11139:2006, definition 2.17]
3.12
ethylene oxide (EO) injection time
duration of the stage beginning with the first introduction of the EO (mixture) into the chamber to the
completion of that injection
3.13
exposure time
period for which the process parameters are maintained within their specified tolerances
[SOURCE: ISO/TS 11139:2006, definition 2.18]
Note 1 to entry: For the purpose of calculation of cycle lethality, it is the period of sterilization between the end of
EO injection and the beginning of EO removal.
3.14
fault
one or more of the process parameters lying outside of its/their specified tolerance(s)
[SOURCE: ISO/TS 11139:2006, definition 2.19]
3.15
flushing
procedure by which the ethylene oxide is removed from the load and chamber by either multiple alternate
admissions of filtered air, inert gas or steam and evacuations of the chamber or continuous passage of
filtered air, inert gas or steam through the load and chamber
3.16
fractional cycle
a cycle in which the exposure time to EO gas is reduced compared to that specified in the sterilization
process
4 © ISO 2014 – All rights reserved

ISO 11135:2014(E)
3.17
half cycle
a cycle in which the exposure time to EO gas is reduced by 50 % compared to that specified in the
sterilization process
3.18
health care facility
HCF
governmental and private organizations and institutions devoted to the promotion and maintenance of
health, and the prevention and treatment of diseases and injuries
EXAMPLE A health care facility can be a hospital, nursing home, extended care facility, free-standing surgical
centre, clinic, medical office, or dental office.
3.19
health care product
medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including
biopharmaceutical(s)
[SOURCE: ISO/TS 11139:2006, definition 2.20]
3.20
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[SOURCE: ISO/TS 11139:2006, definition 2.22]
3.21
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or related article, intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the specific purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,
— investigation, replacement or modification or support of the anatomy or of a physiological process,
— control of conception,
— disinfection of medical devices,
— providing information for medical purposes by means of in vitro examination of specimens derived
from the human body,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[SOURCE: ISO 13485:2003, definition 3.7]
3.22
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
Note 1 to entry: A specific standard might not require demonstration of the effectiveness of the sterilization
process in inactivating all types of microorganisms, identified in the definition above, for validation and/or
routine control of the sterilization process.
[SOURCE: ISO/TS 11139:2006, definition 2.26]
ISO 11135:2014(E)
3.23
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
[SOURCE: ISO/TS 11139:2006, definition 2.27]
3.24
overkill approach
approach using sterilization process that delivers a minimum of 12 Spore Log Reduction (SLR) to a
biological indicator having a resistance equal to or greater than the product bioburden
3.25
parametric release
declaration that product is sterile, based on records demonstrating that the process parameters were
delivered within specified tolerances
[SOURCE: ISO/TS 11139:2006, definition 2.29]
Note 1 to entry: This method of process release does not include the use of biological indicators.
3.26
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in
accordance with operational procedures, consistently performs in accordance with predetermined
criteria and thereby yields product meeting its specification
[SOURCE: ISO/TS 11139:2006, definition 2.30]
3.27
preconditioning
treatment of product, prior to the sterilization cycle, in a room or chamber to attain specified conditions
for temperature and relative humidity
3.28
process challenge device
PCD
item designed to constitute a defined resistance to a sterilization process and used to assess performance
of the process
[SOURCE: ISO/TS 11139:2006, definition 2.33]
Note 1 to entry: For the purpose of this International Standard, a PCD can be product, simulated product or other
device that is inoculated directly or indirectly. See 7.1.6 and D.7.1.6.
Note 2 to entry: In this International Standard, a distinction is made between an internal PCD and an external
PCD. An internal PCD is used to demonstrate that the required product SAL is achieved. A PCD located within
the confines of the product or product shipper case is an internal PCD, whereas a PCD located between shipper
cases or on the exterior surfaces of the load is an external PCD. An external PCD is an item designed to be used for
microbiological monitoring of routine production cycles.
3.29
process parameter
specified value for a process variable
Note 1 to entry: The specification for a sterilization process includes the process parameters and their tolerances.
[SOURCE: ISO/TS 11139:2006, definition 2.34]
6 © ISO 2014 – All rights reserved

ISO 11135:2014(E)
3.30
process variable
condition within a sterilization process, changes in which alter microbicid
...