EN ISO 17665-1:2006

SLOVENSKI STANDARD
01-oktober-2006
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SIST EN 554:2000
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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 17665-1:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 17665-1:2006)
Stérilisation des produits de santé - Chaleur humide - Partie 1: Exigences pour le
développement, la validation et le contrôle de routine d'un procédé de stérilisation des
dispositifs médicaux (ISO 17665-1:2006)
Ta slovenski standard je istoveten z: EN ISO 17665-1:2006
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 17665-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2006
ICS 11.080.01 Supersedes EN 554:1994
English Version
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 17665-
1:2006)
Stérilisation des produits de santé - Chaleur humide - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences pour le développement, la validation et Feuchte Hitze - Teil 1: Anforderungen an die Entwicklung,
le contrôle de routine d'un procédé de stérilisation des Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 17665-1:2006) Sterilisationsverfahrens für Medizinprodukte (ISO 17665-
1:2006)
This European Standard was approved by CEN on 14 July 2006.
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, Romania,
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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17665-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 17665-1:2006) 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 February 2007, and conflicting national standards
shall be withdrawn at the latest by August 2009.

This document supersedes EN 554:1994.

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

Endorsement notice
The text of ISO 17665-1:2006 has been approved by CEN as EN ISO 17665-1:2006 without any
modifications.
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC, 93/42/EEC and 98/79/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 EU Directives 90/385/EEC, 93/42/EEC and
98/79/EC.
Once this European 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, as shown 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 Directives 90/385/EEC,
93/42/EEC and 98/79/EC
Clause(s)/Sub- Essential Essential Essential Qualifying
clause(s) of this EN Requirements Requirements Requirements remarks/
(ERs) of (ERs) of (ERs) of Notes
Directive Directive Directive
90/385/EEC 93/42/EEC 98/79/EC
In part
4, 5, 6, 7, 8, 9, 10, 7 8.3 B.2.3
11, 12
In part
4, 5, 6, 7, 8, 9, 10, 8.4 B.2.4
11, 12
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this European Standard.

INTERNATIONAL ISO
STANDARD 17665-1
First edition
2006-08-15
Sterilization of health care products —
Moist heat —
Part 1:
Requirements for the development,
validation and routine control of a
sterilization process for medical devices
Stérilisation des produits de santé — Chaleur humide —
Partie 1: Exigences pour le développement, la validation et le contrôle
de routine d'un procédé de stérilisation des dispositifs médicaux

Reference number
ISO 17665-1:2006(E)
©
ISO 2006
ISO 17665-1:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 17665-1:2006(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 system elements . 10
4.1 Documentation. 10
4.2 Management responsibility . 10
4.3 Product realization. 10
4.4 Measurement, analysis and improvement — Control of non-conforming product . 10
5 Sterilizing agent characterization . 11
5.1 Sterilizing agent . 11
5.2 Microbicidal effectiveness . 11
5.3 Materials effects. 11
5.4 Environmental consideration . 11
6 Process and equipment characterization . 11
6.1 Process . 11
6.1.1 General. 11
6.1.2 Saturated steam processes . 12
6.1.3 Contained product processes . 12
6.2 Equipment . 13
7 Product definition . 14
8 Process definition. 15
9 Validation. 17
9.1 General. 17
9.2 Installation qualification (IQ) . 17
9.2.1 Equipment . 17
9.2.2 Installation . 17
9.2.3 Function. 17
9.3 Operational qualification (OQ). 18
9.4 Performance qualification (PQ) . 18
9.5 Review and approval of validation. 19
10 Routine monitoring and control . 20
11 Product release from sterilization. 21
12 Maintaining process effectiveness . 21
12.1 Demonstration of continued effectiveness. 21
12.2 Recalibration . 21
12.3 Maintenance of equipment . 21
12.4 Requalification . 22
12.5 Assessment of change. 22
Annex A (informative) Guidance. 23
Annex B (informative) Process definition based on inactivation of the microbial population in its
natural state (bioburden-based method).27
ISO 17665-1:2006(E)
Annex C (informative) Process definition based on the inactivation of a reference microorganism
and a knowledge of bioburden on product items to be sterilized (combined
bioburden/biological indicator based method). 28
Annex D (informative) Conservative process definition based on inactivation of reference
microorganisms (overkill method) . 29
Annex E (informative) Operating cycles. 31
Bibliography . 36

iv © ISO 2006 – All rights reserved

ISO 17665-1:2006(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 17665-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This first edition of ISO 17665-1 cancels and replaces ISO 11134:1994 and ISO 13683:1997 both of which
have been technically revised.
ISO 17665 consists of the following parts, under the general title Sterilization of health care products — Moist
heat:
⎯ Part 1: Requirements for the development, validation and routine control of a sterilization process for
medical devices
⎯ Part 2: Guidance on the application of ISO 17665-1
ISO 17665-1:2006(E)
Introduction
A sterile medical device is one which is free of viable microorganisms. International standards that specify
requirements for validation and routine control of sterilization processes require, when it is necessary to
supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to
sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in
accordance with the requirements for quality management systems (see, for example, ISO 13485) may, prior
to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The
purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile
products into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to
sterilize medical devices generally can best be described by an exponential relationship between the number
of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that
there is always a finite probability that a microorganism may 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 product 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 product item.
ISO 17665 describes requirements that, if met, will provide a moist heat sterilization process intended to
sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the
requirements ensures this activity is both reliable and reproducible so that predictions can be made, with
reasonable confidence, that there is a low level of probability of there being a viable microorganism present on
product after sterilization. Specification of this probability is a matter for regulatory authorities and may vary
from country to country (see, for example, EN 556-1 and ANSI/AAMI ST67).
Generic requirements of the quality management system 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 recognise that, for
certain processes used in manufacturing, 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 is monitored
routinely and the equipment is 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 factors including:
a) the microbiological status of incoming raw materials and/or components;
b) the validation and routine control of any cleaning and disinfection procedures used on the product;
c) the control of the environment in which the product is manufactured, assembled and packaged;
d) the control of equipment and processes;
e) the control of personnel and their hygiene;
f) the manner and materials in which the product is packaged;
g) the conditions under which product is stored.
vi © ISO 2006 – All rights reserved

ISO 17665-1:2006(E)
The type of contamination on a product to be sterilized varies and this has an impact upon the effectiveness of
a sterilization process. It is preferable that products that have been used in a health care setting and that are
being presented for resterilization in accordance with the manufacturer's instructions (see ISO 17664) be
regarded as special cases. 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, particular attention has to be given to the validation and control of the cleaning and
disinfection processes used during reprocessing.
This part of ISO 17665 describes the requirements for ensuring that the activities associated with the process
of moist heat sterilization are performed properly. These activities are described in documented work
programmes designed to demonstrate that the moist heat sterilization process will consistently yield sterile
products on treatment with process variables falling within the predetermined limits.
The requirements are the normative parts of this part of ISO 17665 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 provides explanations and methods that are regarded as being suitable means for complying with
the requirements. Methods other than those given in the guidance may be used, if they are effective in
achieving compliance with the requirements of this part of ISO 17665.
The development, validation and routine control of a sterilization process comprise 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 this part
of ISO 17665 have been grouped together and are presented in a particular order, this part of ISO 17665 does
not require that the activities be performed in the order that 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 undertake one or more of these activities. This part of ISO 17665 does not specify the particular
individuals or organizations to carry out the activities.

INTERNATIONAL STANDARD ISO 17665-1:2006(E)

Sterilization of health care products — Moist heat —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a
moist heat sterilization process for medical devices.
NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other health care products.
1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to:
a) saturated steam venting systems;
b) saturated steam active air removal systems;
c) air steam mixtures;
d) water spray;
e) water immersion.
NOTE See also Annex E.
1.2 Exclusions
1.2.1 This part of ISO 17665 does not specify requirements for 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 also ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This part of ISO 17665 does not apply to those sterilization processes that are based on a
combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.
1.2.3 This part of ISO 17665 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.
ISO 17665-1:2006(E)
1.2.4 This part of ISO 17665 does not specify a quality management system for the control of all stages of
production of medical devices.
NOTE It is not a requirement of this part of ISO 17665 to have a complete quality management system during
manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization
process 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 of medical devices,
including the sterilization process. Regional and national regulations for the provision of medical devices might require
implementation of a complete quality management system and the assessment of that system by a third party.
1.2.5 This part of ISO 17665 does not specify requirements for occupational safety associated with the
design and operation of moist heat sterilization facilities.
NOTE Requirements for operational safety are specified in IEC 61010-2-040. Additionally, safety regulations exist in
some countries.
2 Normative references
The following referenced documents are indispensable for the application of this document. 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 11138-1, Sterilization of health care products — Biological indicators — Part 1: General Requirements
ISO 11138-3, Sterilization of health care products — Biological indicators — Part 3: Biological indicators for
moist heat sterilization processes
ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems
for use in the Bowie and Dick steam penetration test
ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an
alternative to Bowie and Dick test for detection of steam penetration
ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for
Bowie and Dick air removal test sheets and packs
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
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 validation of a sterilization process
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
2 © ISO 2006 – All rights reserved

ISO 17665-1:2006(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air detector
device designed to detect the presence of non-condensable gases in a stream of steam and condensate or in
the sterilizer chamber
3.2
automatic controller
〈sterilization〉 device that, in response to pre-determined operating cycle variables, operates the sterilizer
sequentially through the required stages of the operating cycle(s)
3.3
bioburden
population of viable microorganisms on and/or in a product and/or sterile barrier system
[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
[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
[VIM:1993, definition 6.11]
3.6
chemical indicator
non-biological indicator
test system that reveals change in one or more pre-defined process variables based on a chemical or physical
change resulting from exposure to a process
[ISO/TS 11139:2006, definition 2.6]
3.7
contained product
product for which the environment within the sterilizer during any stage of the sterilization process does not
come into direct contact with the product
NOTE The environment within the sterilizer is used for heating and cooling purposes only, not for achieving the
sterilization effect; e.g. a solution in a sealed bottle.
3.8
correction
action to eliminate a detected nonconformity
NOTE A correction can be made in conjunction with a corrective action.
[ISO 9000:2005, definition 3.6.6]
ISO 17665-1:2006(E)
3.9
corrective action
action to eliminate the cause of a detected nonconformity or other undesirable situation
NOTE 1 There can be more than one cause for a nonconformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
NOTE 3 There is a distinction between correction and corrective action.
[ISO 9000:2005, definition 3.6.5]
3.10
D value
D value
time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated
conditions
[ISO/TS 11139:2006, definition 2.11]
NOTE For the purposes of this part of ISO 17665 D-value refers to the exposure necessary to achieve 90 %
reduction.
3.11
development
act of elaborating a specification
[ISO/TS 11139:2006, definition 2.13]
3.12
environmental control
application of engineering and/or procedural systems to maintain conditions in defined areas within specified
limits
NOTE Such systems can include air and fluid filters, surface disinfection, protective clothing and administrative
procedures.
[ISO/TS 11139:2006, definition 2.16]
3.13
equilibration time
period which elapses between the attainment of the sterilization temperature at the reference measuring point
and the attainment of the sterilization temperature at all points within the sterilization load
3.14
establish
determine by theoretical evaluation and confirm by experimentation
[ISO/TS 11139:2006, definition 2.17]
3.15
exposure time
period for which the process parameters are maintained within their specified tolerances
[ISO/TS 11139:2006, definition 2.18]
3.16
fault
one or more of the process parameters lying outside its/their specified tolerance(s)
[ISO/TS 11139:2006, definition 2.19]
4 © ISO 2006 – All rights reserved

ISO 17665-1:2006(E)
3.17
F value
microbiological lethality of a sterilization process expressed in terms of the equivalent time, in minutes, at a
temperature of 121,1 °C with reference to microorganisms with a z value of 10 °C
3.18
health care product(s)
medical device(s) including in vitro diagnostic medical device(s) or medicinal product(s) including
biopharmaceutical(s)
[ISO/TS 11139:2006, definition 2.20]
3.19
holding time
〈sterilization〉 period for which the temperatures at the reference measurement point and at all points within the
sterilization load are continuously within the sterilization temperature band
3.20
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[ISO/TS 11139:2006, definition 2.22]
3.21
load configuration
specified configuration within the sterilization chamber of the items of fixed chamber parts and the numbers,
types, distribution and orientation of product presented for sterilization
3.22
maintenance
〈sterilization〉 combination of all technical and associated administrative actions intended to retain an item at/or
restore it to a state in which it can perform its required function
3.23
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other 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, modification or support of the anatomy or of a physiological process;
⎯ supporting or sustaining life;
⎯ 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;
ISO 17665-1:2006(E)
and which does not achieve its primary 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
[ISO 13485:2003, definition 3.7]
NOTE This definition from ISO 13485:2003 was developed by the Global Harmonization Task Force (GHTF 2002).
3.24
measuring chain
series of elements of a measuring instrument or measuring system, which constitutes the path of the
measurement signal from the input (quantity subject to measurement) to the output (the result of the
measurement)
3.25
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
NOTE A specific standard might not require demonstration of the effectiveness of the sterilization process in
inactivating all types of microorganism identified in the definition above, for validation and/or routine control of the
sterilization process.
[ISO/TS 11139:2006, definition 2.26]
3.26
moist heat
thermal energy in the presence of moisture provided as steam or liquid water for the purpose of achieving
microbial lethality
3.27
non-condensable gas
air and/or other gas which will not liquefy under the conditions of a saturated steam processes
3.28
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures
[ISO/TS 11139:2006, definition, 2.27]
3.29
operating cycle
complete set of stages of the process, carried out in a specified sequence
[IEC 61010-2-040:2005]
3.30
packaging system
combination of the sterile barrier system and protective packaging
[ISO/TS 11139:2006, definition, 2.28]
3.31
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
[ISO/TS 11139:2006, definition 2.30]
6 © ISO 2006 – All rights reserved

ISO 17665-1:2006(E)
3.32
preventive action
action to eliminate the cause of a potential nonconformity or other undesirable potential situation
NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
[ISO 9000:2005, definition 3.6.4]
3.33
plateau period
equilibration time plus the holding time
3.34
process challenge device
PCD
item designed to constitute a defined resistance to a sterilization process and used to assess performance of
the process
[ISO/TS 11139:2006, definition 2.33]
3.35
process parameter
specified value for a process variable
NOTE The specification for a sterilization process includes the process parameters and their tolerances.
[ISO/TS 11139:2006, definition 2.34]
3.36
process variable
condition within a sterilization process, changes in which alter microbicidal effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.
[ISO/TS 11139:2006, definition 2.35]
3.37
product
result of a process
NOTE For the purposes of sterilization standards, product is tangible and can be raw material(s) intermediates, sub-
assembly(ies) and healthcare product(s).
[ISO/TS 11139:2006, definition 2.36]
3.38
product family
〈sterilization〉 groups or subgroups of product characterized by similar attributes such as mass, material,
construction, shapes, lumens, packaging system and which present a similar challenge to the sterilization
process
3.39
reference challenge device
device having a known thermal relationship to the contained product or sterilization load
3.40
reference load
specified sterilization load(s) created to represent difficult combinations of items to be sterilized
ISO 17665-1:2006(E)
3.41
reference measuring point
point where the temperature sensor used for the operating cycle control is located
3.42
reference microorganism
microbial strain obtained from a recognized culture collection
[ISO/TS 11139:2006, definition 2.39]
3.43
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified process
[ISO/TS 11139:2006, definition 2.40]
3.44
saturated steam
water vapour in a state of equilibrium between condensation and evaporation
3.45
services
supplies from an external source, needed for the function of equipment
EXAMPLE Electricity, water, compressed air, drainage.
[ISO/TS 11139:2006, definition 2.41]
3.46
specification
document stating requirements
[ISO 9000:2005, definition 3.7.3]
3.47
specify
stipulate in detail within an approved document
[ISO/TS 11139:2006, definition 2.42]
3.48
sterile
free from viable microorganisms
[ISO/TS 11139:2006, definition 2.43]
3.49
sterility
state of being free from viable microorganisms
NOTE In practice, no such absolute statement regarding the absence of microorganisms can be proven
[see sterilization (3.51)].
[ISO/TS 11139:2006, definition 2.45]
8 © ISO 2006 – All rights reserved

ISO 17665-1:2006(E)
3.50
sterility assurance level
SAL
probability of a single viable microorganism occurring on an item after sterilization
−6 −3
NOTE The term SAL takes a quantitative value, generally 10 or 10 . When applying this quantitative value to
−6 −3
assurance of sterility, an SAL of 10 has a lower value but provides a greater assurance of sterility than an SAL of 10 .
[ISO/TS 11139:2006, definition 2.46]
3.51
sterilization
validated process used to render product free from viable microorganisms
NOTE In a sterilization process, the nature of microbial inactivation is exponential and thus, the survival of a
microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a
very low number, it can never be reduced to zero [see sterility assurance level (3.50)].
[ISO/TS 11139:2006, definition 2.47]
3.52
sterilization load
product to be, or that has been, sterilized together using a given sterilization process
[ISO/TS 11139:2006, definition 2.48]
3.53
sterilization process
series of actions or operations needed to achieve the specified requirements for sterility
NOTE This series of actions includes pre-treatment of product (if necessary), exposure to the sterilizing agent under
defined conditions and any necessary post treatment. The sterilization process does not include any cleaning, disinfection
or packaging operations that precede sterilization.
[ISO/TS 11139:2006, definition 2.49]
3.54
sterilization temperature
minimum temperature of the sterilization temperature band
3.55
sterilization temperature band
range of temperatures, expressed as the sterilization temperature and the maximum permissible temperature
which may prevail throughout the sterilization load during the holding time
3.56
sterilizer chamber
part of the sterilizer which receives the sterilization load
3.57
sterilizing agent
physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility
under defined conditions
[ISO/TS 11139:2006, definition 2.50]
3.58
thermal energy
energy in the form of heat
ISO 17665-1:2006(E)
3.59
test of sterility
technical operation performed as part of development, validation or requalification to determine the presence
or absence of viable microorganisms on product or portions thereof
[ISO/TS 11139:2006, definition 2.54]
3.60
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a process
will consistently yield product complying with predetermined specification
[ISO/TS 11139:2006, definition 2.55]
3.61
z value
temperature change required to effect a ten fold change in D value
4 Quality management system elements
4.1 Documentation
4.1.1 Procedures for the development, validation, routine control and product release from sterilization shall
be specified.
4.1.2 Documents and records required by this part of ISO 17665 shall be reviewed and approved by
designated personnel (see 4.2.1). Documents and records shall be controlled in accordance with the
applicable clauses of ISO 13485.
4.2 Ma
...