oSIST prEN ISO 11137-1:2023
(Main)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)
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)
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)
General Information
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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.
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oSIST prEN ISO 11137-1:2023
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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.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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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.
COPYRIGHT PROTECTED DOCUMENT
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© ISO 2023
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NATIONAL REGULATIONS.
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ii
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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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
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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);
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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
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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.
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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.
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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.
1
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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]
2
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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
...
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