FprEN ISO 11137-1
(Main)Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024)
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024)
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document 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 document 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 can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO/FDIS 11137‑1:2024)
1.1 Dieses Dokument legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung eines Strahlensterilisationsverfahrens für Medizinprodukte fest.
ANMERKUNG Obgleich der Anwendungsbereich auf Medizinprodukte begrenzt ist, kann dieses Dokument auch auf andere Produkte und Ausrüstungen angewendet werden.
Durch dieses Dokument erfasste Strahlensterilisationsverfahren wenden Bestrahlungsanlagen an:
a) die die Radionuklide 60Co oder 137Cs verwenden,
b) in denen beschleunigte Elektronen erzeugt werden, oder
c) in denen X-Rays (Röntgenstrahlen) erzeugt werden.
1.2 Dieses Dokument ist nicht anwendbar auf Verfahren zur Inaktivierung von Viren oder Verursachern spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalitis und Creutzfeldt-Jakob-Krankheit.
ANMERKUNG Informationen zu solchen Verfahren finden sich in ISO 22442 1, ISO 22442 2, ISO 22442 3, ISO 13022 und ICH Q5A.
1.2.1 Dieses Dokument legt keine Anforderungen zur Kennzeichnung eines Medizinprodukts als steril fest.
ANMERKUNG Regionale und nationale Anforderungen können Medizinprodukte als steril kennzeichnen. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
1.2.2 Dieses Dokument legt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG Es ist keine Anforderung dieses Dokuments, dass bei der Herstellung ein vollständiges Qualitätsmanagementsystem vorhanden ist, aber die als Minimum erforderlichen Elemente eines Qualitätsmanagementsystems zur Lenkung des Sterilisationsverfahrens werden an geeigneten Stellen im Text als normative Verweisungen angeführt (siehe im Besonderen Abschnitt 4). Zu beachten sind die Normen über Qualitätsmanagementsysteme (siehe ISO 13485), die alle Stufen der Herstellung von Medizinprodukten lenken einschließlich des Sterilisationsverfahrens. Regionale und nationale Bestimmungen für die Bereitstellung von Medizinprodukten können die Umsetzung eines vollständigen Qualitätsmanagementsystems und die Beurteilung dieses Systems durch eine dritte Seite erfordern.
1.2.3 Dieses Dokument fordert nicht den Einsatz biologischer Indikatoren für die Validierung oder Lenkung der Strahlensterilisation oder dass für die Produktfreigabe eine Prüfung auf Sterilität nach einem Arzneibuch durchgeführt wird.
1.2.4 Dieses Dokument legt keine Anforderungen an den Arbeitsschutz fest, die mit dem Design und dem Betrieb von Bestrahlungsanlagen zusammenhängen.
ANMERKUNG In einigen Ländern gibt es Vorschriften über Sicherheitsanforderungen für den Arbeitsschutz im Zusammenhang mit Bestrahlung.
1.2.5 Dieses Dokument legt keine Anforderungen für die Sterilisation gebrauchter oder wiederaufbereiteter Medizinprodukte fest.
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux (ISO/FDIS 11137-1:2024)
1.1 Le présent document spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine d’un procédé de stérilisation par irradiation pour les dispositifs médicaux.
NOTE Bien que le domaine d’application se limite aux dispositifs médicaux, le présent document peut être applicable à d’autres produits et équipements.
Le présent document couvre les procédés d’irradiation utilisant des irradiateurs, qui utilisent:
a) les radionucléides 60Co ou 137Cs;
b) un faisceau à partir d’un générateur d’électrons; ou
c) un faisceau à partir d’un générateur de rayons X.
1.2 Le présent document n’est pas applicable aux procédés d’inactivation des virus ou des agents responsables des encéphalopathies spongiformes telles que la tremblante du mouton, l’encéphalopathie spongiforme bovine et la maladie de Creutzfeldt-Jakob.
NOTE Pour plus d’informations sur ces procédés, voir l’ISO 22442-1, l’ISO 22442-2, l’ISO 22442-3, l’ISO 13022 et l’ICH Q5A.
1.2.1 Le présent document ne spécifie pas les exigences relatives à la désignation d’un dispositif médical stérile.
NOTE Les exigences régionales et nationales peuvent désigner des dispositifs médicaux stériles. Voir, par exemple, l’EN 556-1 ou l’ANSI/AAMI ST67.
1.2.2 Le présent document ne spécifie pas de système de management de la qualité pour le contrôle de toutes les étapes de production des dispositifs médicaux.
NOTE Il n’est pas exigé par le présent document d’avoir un système de management de la qualité complet durant la fabrication, mais les éléments d’un système de management de la qualité qui sont au minimum nécessaire pour contrôler le procédé de stérilisation sont référencés aux endroits appropriés dans le texte (voir en particulier l’Article 4). L’attention est attirée sur les normes relatives aux systèmes de management de la qualité (voir l’ISO 13485) qui contrôlent toutes les étapes de production des dispositifs médicaux, y compris le procédé de stérilisation. Les réglementations régionales et/ou nationales pour la fourniture de dispositifs médicaux peuvent exiger la mise en place d’un système de management de la qualité complet et l’évaluation de ce système par une tierce partie.
1.2.3 Le présent document n’exige ni l’utilisation d’indicateurs biologiques pour la validation ou la surveillance de la stérilisation par irradiation, ni qu’un essai de stérilité défini dans la pharmacopée soit réalisé pour la libération du produit.
1.2.4 Le présent document ne spécifie pas d’exigences relatives à la sécurité du travail associée à la conception et au fonctionnement des installations d’irradiation.
NOTE Dans certains pays, il peut exister des réglementations sur les exigences relatives à la sécurité au travail liée aux radiations.
1.2.5 Le présent document ne spécifie pas d’exigences relatives à la stérilisation de dispositifs usagés ou retraités.
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO/FDIS 11137-1:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 11137-1:2023
01-junij-2023
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 11137-1:2023)
Sterilization of health care products - Radiation - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices (ISO/DIS
11137-1:2023)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11137-1:2023)
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives à la mise
au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les
dispositifs médicaux (ISO/DIS 11137-1:2023)
Ta slovenski standard je istoveten z: prEN ISO 11137-1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11137-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 11137-1:2023
oSIST prEN ISO 11137-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-14 2023-07-07
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
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oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General . 9
5 Sterilizing agent characterization .10
5.1 Sterilizing agent . 10
5.2 Microbicidal effectiveness . . 10
5.3 Material effects . 10
5.4 Environmental considerations . 10
6 Process and equipment characterization .10
6.1 Process . 10
6.2 Equipment . 10
7 Product definition .12
8 Process definition .12
8.1 Establishing the maximum acceptable dose, D .12
max,acc
8.2 Establishing the sterilization dose, D . 13
ster
8.3 Specifying the maximum acceptable dose and the sterilization dose .13
8.4 Transference of maximum acceptable, verification or sterilization dose between
radiation sources .13
8.4.1 Transference of maximum acceptable dose .13
8.4.2 Transference of verification dose or sterilization dose . 14
9 Validation . .14
9.1 Installation qualification . 14
9.2 Operational qualification . 14
9.3 Performance qualification.15
9.4 Review and approval of validation . 16
10 Routine monitoring and control.17
11 Product release from sterilization .17
12 Maintaining process effectiveness .18
12.1 Demonstration of continued effectiveness . 18
12.1.1 General . 18
12.1.2 Frequency of determinations of bioburden . 18
12.1.3 Frequency of sterilization dose audits . 18
12.2 Recalibration . 20
12.3 Maintenance of equipment . 20
12.4 Requalification . 20
12.5 Assessment of change . 20
Annex A (informative) Guidance .21
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .36
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered .40
Bibliography .43
iii
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(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 (see 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 (see 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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11137-1:2006 and its amendments),
which has been technically revised.
The main changes compared to the previous edition are as follows:
— addition of ISO 13004 as a normative reference;
— addition of the ASTM standard practice for dosimetry in radiation processing as a normative
reference and alignment of terminology across the document to ASTM standards terminology;
— replacement of Clause 4 with the updated common Clause 4 for ISO/TC 198 documents;
— increase of the allowable limits above which the potential induced radioactivity shall be assessed to
11 MeV for electrons and 7.5 MeV for X-rays (see 5.1.2);
— addition of a requirement to ensure that failure of a control function does not lead to a failure in
recording process parameters such that an ineffective process appears effective (see 6.1);
— simplification of content on transference of verification dose or sterilization dose based on published
data that demonstrates that differences in operating conditions of the two radiation sources have
no effect on microbicidal effectiveness for product that does not support microbial growth (see
8.4.2);
— addition of references to the Bibliography;
— removal of dosimeter placements and measurements as the means of routine monitoring control
and elimination of specifying the method of measurement (see 10.6 and 10.7);
— clarification has been provided on the allowable interval of time for quarterly dose audits, allowing
for an interval of 4 months provided there are 4 dose audits per year (see 12.1.2);
iv
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
SD
— addition of references for all VD dose levels contained in both ISO 11137-2 and ISO 13004 (see
max
8.2.2 and 12.1.2);
— addition of guidance related to new or modified normative content.
A list of all parts in the ISO 11137 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. International Standards, which
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) can, prior to sterilization, have microorganisms on them. 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 sterilizing agent; inevitably
this means that there is always a finite probability that a microorganism can 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 microorganisms 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.
This document describes requirements that, if met, will provide a radiation sterilization process,
intended to sterilize medical devices, that has appropriate microbicidal activity. Furthermore,
conformance with the requirements ensures that 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 can 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 medical devices are sterile and, in
this regard, suitable for its intended use. Attention is therefore given to a number of considerations
including:
a) the microbiological quality 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.
This document describes the requirements for ensuring that the activities associated with the process
of radiation sterilization are performed properly. These activities are described in documented work
programmes designed to demonstrate that the irradiation process will consistently yield sterile
medical devices on treatment with doses falling within the predetermined limits.
vi
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
The requirements are the normative parts of this document with which conformance 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 a suitable means
for conforming with the requirements. Methods other than those given in the guidance may be used, if
they are effective in achieving conformance with the requirements of this document.
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 document have been grouped together and are presented in a particular order, this
document 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 document does not specify the particular individuals or organizations to carry out the activities.
vii
oSIST prEN ISO 11137-1:2023
oSIST prEN ISO 11137-1:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 11137-1:2023(E)
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
1 Scope
1.1 This document specifies requirements for the development, validation and routine control of a
radiation sterilization process for medical devices.
NOTE Although the scope of this document is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other products and equipment.
This document covers radiation processes employing irradiators using
60 137
a) the radionuclide Co or Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document does not specify requirements for development, validation and routine control
of a process for inactivating viruses or 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, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.1 This document does not detail specified requirements for designating a medical device as sterile.
NOTE Attention is drawn to regional and national requirements for designating medical devices as “sterile.”
See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document 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 document 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 can require implementation of a complete quality management system and the
assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring
of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for
product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design
and operation of irradiation facilities.
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety
requirements for occupational safety related to radiation.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 13004, Sterilization of health care products — Radiation — Substantiation of selected sterilization
SD
dose: Method VD
max
ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 11737-2, Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
ISO/ASTM 52628, Standard practice for dosimetry in radiation processing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
absorbed dose
dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
Note 1 to entry: The unit of absorbed dose is the gray (Gy) where 1 Gy is equivalent to the absorption of 1 J/kg.
Note 2 to entry: For the purposes of this document, the term dose is used to mean “absorbed dose”.
[SOURCE: ISO 11139:2018, 3.3, modified — Dose has been added as an accepted term; notes to entry
have been added.]
3.2
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.3
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified
sterilization process
[SOURCE: ISO 11139:2018, 3.29]
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
3.4
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
[SOURCE: ISO 11139:2018, 3.31]
3.5
change control
assessment and determination of the appropriateness of a proposed alteration to product, process, or
equipment
[SOURCE: ISO 11139:2018, 3.39]
3.6
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in conjunction with corrective action.
[SOURCE: ISO 9000:2015, 3.12.3, modified — Note 2 to entry has been deleted.]
3.7
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.
[SOURCE: ISO 9000:2015, 3.12.2, modified — Note 3 to entry has been deleted.]
3.8
D value
D value
time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test
microorganisms
Note 1 to entry: For the purpose of the ISO 11137 series, the D value refers to the dose necessary to achieve the
90 % reduction.
[SOURCE: ISO 11139:2018, 3.75, modified — Note to entry has been added.]
3.9
development
act of elaborating a specification
[SOURCE: ISO 11139:2018, 3.79]
3.10
dose mapping
measurement of dose distribution and variability in material irradiated under specified conditions
[SOURCE: ISO 11139:2018, 3.87]
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
3.11
dosimeter
device having a reproducible, measurable response to radiation that can be used to measure the
absorbed dose in a given system
[SOURCE: ISO 11139:2018, 3.89]
3.12
dosimetry
measurement of absorbed dose by the use of dosimeters
[SOURCE: ISO 11139:2018, 3.90]
3.13
establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO 11139:2018, 3.107]
3.14
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
[SOURCE: ISO 11139:2018, 3.116]
3.15
health care product
medical device, including in vitro diagnostic medical device, or medicinal product, including
biopharmaceutical
[SOURCE: ISO 11139:2018, 3.132]
3.16
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.17
irradiation container
holder in which product is transported through the irradiator
Note 1 to entry: The holder can be a carrier, cart, tray, product carton, pallet or other container.
[SOURCE: ISO 11139:2018, 3.146]
3.18
irradiator operator
company or body responsible for irradiation of product
[SOURCE: ISO 11139:2018, 3.147]
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
3.19
maximum acceptable dose
D
max,acc
dose given in the process specification as the highest dose that can be applied to a specified product
without compromising safety, quality or performance
Note 1 to entry: The specification for maximum acceptable dose may apply to an entire product or a defined
portion of a product.
[SOURCE: ISO 11139:2018, 3.161, modified — Note 1 to entry has been added.]
3.20
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software,
material or other similar 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, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been added.]
3.21
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 11139:2018, 3.176, modified — Note to entry has been added.]
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
3.22
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 11139:2018, 3.220.3]
3.23
performance qualification
PQ
process of establishing by objective evidence that the process, under anticipated conditions, consistently
produces a product which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.24
preventive action
action to eliminate the cause of a potential nonconformity or other potential undesirable situation
Note 1 to entry: There can be more than one cause for a potential nonconformity.
Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent
recurrence.
[SOURCE: ISO 9000:2015, 3.12.1]
3.25
process interruption
intentional or unintentional stoppage of the irradiation process
3.26
process load
volume of material with a specified product loading configuration irradiated as a single entity
[SOURCE: ISO/ASTM 52303:2015, 3.1.10]
3.27
process parameter
specified value for a process variable
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
Note 2 to entry: In the context of this standard the term “tolerances” is used as “limits”.
[SOURCE: ISO 11139:2018, 3.211, modified — Note 2 to entry has been added.]
3.28
process variable
chemical or physical attribute within a cleaning, disinfection, packaging, or sterilization process,
changes in which can alter its effectiveness
EXAMPLE Conveyor speed, beam current, electron energy, beam width.
[SOURCE: ISO 11139:2018, 3.213, modified — EXAMPLE has been replaced by a list of process variables
specific to radiation processes]
3.29
processing category
collection of different product or product families that can be processed together
Note 1 to entry: Processing categories can be based on, for instance, composition, homogeneity, density or dose
requirements.
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
[SOURCE: ISO 11139:2018, 3.215, modified — Note 1 to entry has been added.]
3.30
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), health care product(s).
[SOURCE: ISO 11139:2018, 3.217]
3.31
product family
group or subgroup of product characterized by similar attributes determined to be equivalent for
evaluation and processing purposes
Note 1 to entry: Members of a radiation sterilization product family can be given the same sterilization dose.
[SOURCE: ISO 11139:2018, 3.218, modified — Note 1 to entry has been added.]
3.32
requalification
repetition of part or all of validation for the purpose of confirming the continued acceptability of a
specified process
[SOURCE: ISO 11139:2018, 3.220.5]
3.33
services
supplies from an external source needed for the function of equipment
EXAMPLE Electricity, water, compressed air, drainage.
[SOURCE: ISO 11139:2018, 3.252, modified — EXAMPLE has been added.]
3.34
specification
approved document stipulating requirements
3.35
specify
stipulate in detail within an approved document
[SOURCE: ISO 11139:2018, 3.259]
3.36
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.37
sterility
state of being free from viable microorganisms
Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven.
[SOURCE: ISO 11139:2018, 3.274]
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
3.38
sterility assurance level
SAL
probability of a single viable microorganism occurring on an item after sterilization
Note 1 to entry: It is expressed as the negative exponent to the base 10.
–6 –3
Note 2 to entry: The term SAL takes a quantitative value, generally 10 or 10 .
[SOURCE: ISO 11139:2018, 3.275, modified — Note 2 to entry has been added.]
3.39
sterilization
validated process used to render product free from viable microorganisms
Note 1 to entry: 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.
[SOURCE: ISO 11139:2018, 3.277]
3.40
sterilization dose
SD
D
ster
minimum dose to achieve the specified requirements for sterility
[SOURCE: ISO 11139:2018, 3.280, modified — Added the term D .]
ster
3.41
sterilization process
series of actions or operations needed to achieve the specified requirements for sterility
Note 1 to entry: This series of actions includes pre-treatment of product (if necessary), exposure under specified
conditions to the sterilizing agent and any necessary post treatment. The sterilization process does not include
any cleaning, disinfection, or packaging operations that precede sterilization.
[SOURCE: ISO 11139:2018, 3.284]
3.42
sterilizing agent
physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve
sterility under specified conditions
[SOURCE: ISO 11139:2018, 3.288]
3.43
test for sterility
technical operation specified in a pharmacopoeia performed on product following an aseptic process or
exposure to a sterilization process
[SOURCE: ISO 11139:2018, 3.298]
3.44
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
[SOURCE: ISO 11139:2018, 3.299]
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
3.45
transit dose
dose absorbed during travel of product or source to or from the non-irradiation to the irradiation
position
[SOURCE: ISO 11139:2018, 3.305]
3.46
uncertainty of measurement
measurement uncertainty
non-negative parameter characterizing the dispersion of the quantity values being attributed to a
measurand, based on the information used
[SOURCE: VIM: 2012, definition 2.26, modified — The notes to entry have been deleted.]
3.47
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination
such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
[SOURCE: ISO 9000:2015, 3.8.13, modified — “process” has been added to the definition.]
4 General
4.1 The development, validation and routine control of a sterilization process is a critical element
in product realization of health care product. To ensure the consistent implementation of the
requirements specified in this document, the necessary processes need to be established, implemented
and maintained. Processes of particular importance in relation to the development, validation and
routine control of a sterilization process include but are not limited to:
— control of documentation, including records,
— assignment of management responsibility,
— provision of adequate resources, including competent human resources and infrastructure,
— control of product provided by external parties,
— identification and traceability of product throughout the process, and
control of non-conforming product.
NOTE ISO 13485 covers all stages of the lifecycle of medical devices in the context of quality management
systems for regulatory purposes. National and/or regional regulatory requirements for the provision of health
care product can require the implementation of a full quality management system and the assessment of that
system by a recognized conformity assessment body.
4.2 A process shall be specified for the calibration of all equipment, including instrumentation for
test purposes, used in meeting the requirements of this document.
4.3 Dosimetry used in the development, validation and routine control of the sterilization process
shall have measurement traceability to national or International Standards and shall have a known
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
level of uncertainty. Processes for dosimetry meeting the requirements of ISO/ASTM 52628 shall be
specified.
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.1.1 The source of radiation to be used in sterilization processing shall be specified (e.g. gamma ray,
electron beam or X-ray).
5.1.2 For electrons or X-rays, the energy level of the electron beam shall be specified. If the energy
level for electrons exceeds 11 MeV or the energy level for electrons used to generate X-rays exceeds
7.5 MeV, the potential for induced radioactivity in product and packaging system shall be assessed. The
outcome of the assessment and the rationale for decisions reached shall be documented.
5.2 Microbicidal effectiveness
The inactivation of microorganisms by radiation and the use of radiation in sterilization processes
have been comprehensively documented in the literature. This literature provides knowledge of the
manner in which the process variables affect microbial inactivation. Reference to these general studies
on microbial inactivation is not required by this document.
5.3 Material effects
The effects of radiation on a wide variety of materials used to manufacture medical devices have been
comprehensively documented and the resultant documentation is of value to those designing and
developing medical devices that are to be sterilized by radiation. This document does not require the
performance of studies on material effects, but does require performance of studies of the effects of
radiation on product and packaging system (see 8.1).
5.4 Environmental considerations
The potential effect on the environment of the operation of the r
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