SIST EN ISO 11137-1:2006

SLOVENSKI STANDARD
SIST EN ISO 11137-1:2006
01-julij-2006
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SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
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SULSRPRþNH,62
Sterilization of health care products - Radiation - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices (ISO 11137-
1:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 11137-1:2006)
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives a la mise
au point, a la validation et au contrôle de routine d'un procédé de stérilisation pour les
dispositifs médicaux (ISO 11137-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11137-1:2006
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-1:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11137-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.01 Supersedes EN 552:1994
English Version
Sterilization of health care products - Radiation - Part 1:
Requirements for development, validation and routine control of
a sterilization process for medical devices (ISO 11137-1:2006)
Stérilisation des produits de santé - Irradiation - Partie 1: Sterilisation von Produkten für die Gesundheitsfürsorge -
Exigences relatives à la mise au point, à la validation et au Strahlen - Teil 1: Anforderungen an die Entwicklung,
contrôle de routine d'un procédé de stérilisation pour les Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 11137-1:2006) Sterilisationsverfahrens für Medizinprodukte (ISO 11137-
1:2006)
This European Standard was approved by CEN on 13 April 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 11137-1:2006: E
worldwide for CEN national Members.

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EN ISO 11137-1:2006 (E)





Foreword


This document (EN ISO 11137-1:2006) 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 October 2006, and conflicting national standards
shall be withdrawn at the latest by April 2009.

This document supersedes EN 552:1994.

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 11137-1:2006 has been approved by CEN as EN ISO 11137-1:2006 without any
modifications.

2

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EN ISO 11137-1:2006 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC concerning active
implantable medical devices, 93/42/EEC concerning medical devices
and 98/79/EEC concerning in vitro diagnostic medical devices


This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive, EU Directives 90/385/EEC concerning
active implantable medical devices, 93/42/EEC concerning medical devices and 98/79/EEC
concerning in vitro diagnostic medical devices.

Once this 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 given in Table ZA.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding Essential Requirements of that
Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and EU Directives
90/385/EEC concerning active implantable medical devices, 93/42/EEC concerning medical
devices and 98/79/EEC concerning in vitro diagnostic medical devices

Clause(s)/Sub-clause(s) Essential Essential Essential Qualifying
of this European Requirements Requirements Requirements remarks/Notes
Standard (ERs) of Directive (ERs) of (ERs) of Directive
90/385/EEC Directive 98/79/EEC
93/42/EEC
In part
4, 5, 6, 7, 8, 9, 10, 11, 12 7 8.3 B.2.3
In part
4, 5, 6, 7, 8, 9, 10, 11, 12 8.4 B.2.4

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

3

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INTERNATIONAL ISO
STANDARD 11137-1
First edition
2006-04-15


Sterilization of health care products —
Radiation —
Part 1:
Requirements for development, validation
and routine control of a sterilization
process for medical devices
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





Reference number
ISO 11137-1:2006(E)
©
ISO 2006

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ISO 11137-1:2006(E)
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ii © ISO 2006 – All rights reserved

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ISO 11137-1:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management system elements .8
4.1 Documentation. 8
4.2 Management responsibility . 9
4.3 Product realization. 9
4.4 Measurement, analysis and improvement — Control of nonconforming product . 9
5 Sterilizing agent characterization . 9
5.1 Sterilizing agent . 9
5.2 Microbicidal effectiveness . 9
5.3 Material effects. 9
5.4 Environmental considerations . 10
6 Process and equipment characterization . 10
6.1 Process . 10
6.2 Equipment . 10
7 Product definition . 11
8 Process definition. 12
8.1 Establishing the maximum acceptable dose . 12
8.2 Establishing the sterilization dose. 12
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
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. 15
10 Routine monitoring and control . 16
11 Product release from sterilization. 17
12 Maintaining process effectiveness . 17
12.1 Demonstration of continued effectiveness. 17
12.2 Recalibration . 20
12.3 Maintenance of equipment . 20
12.4 Requalification of equipment . 20
12.5 Assessment of change. 20
Annex A (informative) Guidance. 21
Bibliography . 36

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ISO 11137-1:2006(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 11137-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care product.
This first edition, together with ISO 11137-2 and ISO 11137-3, cancels and replaces ISO 11137:1995.
ISO 11137 consists of the following parts, under the general title Sterilization of health care products —
Radiation:
⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical
devices
⎯ Part 2: Establishing the sterilization dose
⎯ Part 3: Guidance on dosimetric aspects
iv © ISO 2006 – All rights reserved

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ISO 11137-1:2006(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) may, prior
to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile.
The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-
sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to
sterilize medical devices can generally best be described by an exponential relationship between the numbers
of microorganisms surviving and the extent of treatment with the 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 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 part of ISO 11137 describes requirements that, if met, will provide a radiation sterilization process
intended to sterilize medical devices, that has appropriate microbicidal activity. Furthermore, compliance 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
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 products are sterile and, in this regard, suitable for its intended
use. Attention is therefore given to a number of considerations 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.
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ISO 11137-1:2006(E)
This part of ISO 11137 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 radiation process will consistently yield sterile products on
treatment with doses falling within the predetermined limits.
The requirements are the normative parts of this part of ISO 11137 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 a 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 11137.
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 11137 have been grouped together and are presented in a particular order, this part of ISO 11137 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 11137 does not specify the particular
individuals or organizations to carry out the activities.
vi © ISO 2006 – All rights reserved

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INTERNATIONAL STANDARD ISO 11137-1:2006(E)

Sterilization of health care products — Radiation —
Part 1:
Requirements for development, validation and routine control
of a sterilization process for medical devices
1 Scope
1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a
radiation sterilization process for medical devices.
NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other products and equipment.
This part of ISO 11137 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 part of ISO 11137 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 Creutzfeld-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 part of ISO 11137 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 part of ISO 11137 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 11137 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.
1.2.3 This part of ISO 11137 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.
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ISO 11137-1:2006(E)
1.2.4 This part of ISO 11137 does not specify requirements for occupational safety associated with the
design and operation of irradiation facilities.
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 part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed
devices.
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 10012-1, Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation
system for measuring equipment
ISO 11137-2:2006, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization
dose
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
absorbed dose
dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
NOTE 1 The unit of absorbed dose is the gray (Gy) where 1 Gy is equivalent to the absorption of 1 J/kg.
NOTE 2 For the purposes of this part of ISO 11137, the term dose is used to mean “absorbed dose”.
3.2
bioburden
population of viable microorganisms on or in the product and/or sterile barrier system
[ISO/TS 11139:2006]
3.3
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
[ISO/TS 11139:2006]
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ISO 11137-1:2006(E)
3.4
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]
3.5
change control
assessment and determination of the appropriateness of a proposed alteration to product or procedure
[ISO/TS 11139:2006]
3.6
correction
action to eliminate a detected nonconformity
NOTE A correction can be made in conjunction with corrective action (3.7).
[ISO 9000:2005]
3.7
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” (3.24) is taken to prevent
occurrence.
NOTE 3 There is a distinction between correction and corrective action.
[ISO 9000:2005]
3.8
D value
D value
10
time or radiation dose required to achieve inactivation of 90 % of a population of the test microorganism under
stated conditions
NOTE For the purpose of the ISO 11137 series, the D value refers to the radiation dose necessary to achieve the
90 % reduction.
[ISO/TS 11139:2006]
3.9
development
act of elaborating a specification
[ISO/TS 11139:2006]
3.10
dose mapping
measurement of dose distribution and variability in material irradiated under defined conditions
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ISO 11137-1:2006(E)
3.11
dosimeter
device having a reproducible, measurable response to radiation, which can be used to measure the absorbed
dose in a given system
[ISO/TS 11139:2006]
3.12
dosimetry
measurement of absorbed dose by the use of dosimeters
3.13
establish
determine by theoretical evaluation and confirm by experimentation
[ISO/TS 11139:2006]
3.14
fault
one or more of the process parameters lying outside of its/their specified tolerance(s)
[ISO/TS 11139:2006]
3.15
health care product(
...