SIST EN ISO 11137-1:2006
(Main)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)
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)
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,
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 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.
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.
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)
1.1 Dieser Teil von ISO 11137 legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwenduung eines Strahlensterilisationsverfahrens für Medizinprodukte fest.
ANMERKUNG Obgleich der Anwendungsbereich von diesem Teil von ISO 11137 auf Medizinprodukte begrenzt ist, legt er Anforderungen fest und liefert Anleitungen, die für andere Produkte und Ausrüstungen gelten können.
Durch diesen Teil von ISO 11137 erfasste Strahlensterilisationsverfahren wenden Bestrahlungsanlagen an,
a) die die Radionuklide 60Co und 137Cs verwenden,
b) in denen beschleunigte Elektronen erzeugt werden
oder
c) in denen durch beschleunigte Elektronen X-Rays (Röntgenstrahlen) genutzt werden.
1.2 Dieser Teil von ISO 11137 legt keine Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Verfahrens zur Inaktivierung der Verursacher spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit fest. In bestimmten Ländern sind spezifische Empfehlungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet worden.
ANMERKUNG Siehe zum Beispiel ISO 22442 1, ISO 22442 2 und ISO 22442 3.
1.2.1 Dieser Teil von ISO 11137 legt keine in den Einzelheiten festgelegte Anforderung zur Kennzeichnung eines Medizinprodukts als steril fest.
ANMERKUNG Zu beachten sind nationale oder regionale Anforderungen für die Kennzeichnung von Medizinprodukten als „steril“. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
1.2.2 Dieser Teil von ISO 11137 legt kein Qualitätsmanagementsystem für die Lenkung der Anwendung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG Es ist keine Anforderung von diesem Teil von ISO 11137, dass bei der Herstellung ein vollständiges Qualitätsmanagementsystem vorhanden ist, aber die als Minimum erforderlichen Elemente eines Qualitätsmanagement-systems zur Lenkung der Anwendung des Sterilisationsverfahrens werden an geeigneten Stellen im Text als normativ
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)
L'ISO 11137-1:2006 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. Bien que le domaine d'application de la présente partie de l'ISO 11137 se limite aux dispositifs médicaux, elle spécifie les exigences et fournit des directives qui peuvent être applicables à d'autres produits et équipements.
L'ISO 11137-1:2006 couvre les procédés d'irradiation utilisant des irradiateurs, qui utilisent les radionucléides 60Co ou 137Cs, un faisceau à partir d'un générateur d'électrons ou un faisceau à partir d'un générateur de rayons X.
L'ISO 11137-1:2006
ne spécifie pas les exigences pour la mise au point, la validation et le contrôle de routine d'un procédé pour l'inactivation des agents responsables des encéphalopathies spongiformes telles que la tremblante du mouton (scrapie en anglais), l'encéphalopathie spongiforme bovine et la maladie de Creutzfeldt-Jakob. Des recommandations spécifiques ont été formulées dans certains pays pour le traitement des matériaux potentiellement contaminés par ces agents,
ne détaille pas les exigences spécifiées pour désigner un dispositif médical stérile,
ne spécifie pas de système de management de la qualité pour le contrôle de toutes les étapes de production des dispositifs médicaux,
n'exige ni l'utilisation d'indicateurs biologiques pour la validation ou la surveillance de la stérilisation par radiation, ni qu'un essai de stérilité défini dans la pharmacopée soit réalisé pour la libération du produit.
ne spécifie pas d'exigences relatives à la sécurité du travail associée à la conception et au fonctionnement des installations d'irradiation.
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 11137-1:2006)
1.1 Ta del standarda ISO 11137 določa zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskega postopka s sevanjem za medicinske pripomočke.
OPOMBA: Čeprav je področje uporabe tega dela standarda ISO 11137 omejeno na medicinske pripomočke, ta standard določa zahteve in navaja smernice, ki so lahko uporabne tudi za druge proizvode in opremo.
Ta del standarda ISO 11137 zajema postopke sevanja z iradiatorji z uporabo:
a) radionuklidov 60Co ali 137Cs,
b) žarka iz generatorja elektronov ali
c) žarka iz generatorja rentgenskega sevanja.
1.2 Ta del standarda ISO 11137 ne določa zahtev za razvoj, validacijo in rutinsko kontrolo postopka za inaktivacijo povzročiteljev spongiformne encefalopatije, kot so praskavec, bovina spongiformna encefalopatija in Creutzfeldt-Jakobova bolezen. V posameznih državah so bila izdelana posebna priporočila za obdelavo materialov, potencialno okuženih s temi povzročitelji.
OPOMBA: Glej na primer ISO 22442-1, ISO 22442-2 in ISO 22442-3.
1.2.1 Ta del standarda ISO 11137 ne določa zahtev za označevanje medicinskega pripomočka kot sterilnega.
OPOMBA: Izpostavljene so regionalne in nacionalne zahteve za označevanje medicinskih pripomočkov kot "sterilnih". Glej na primer EN 556-1 ali ANSI/AAMI ST67.
1.2.2 Ta del standarda ISO 11137 ne določa sistema vodenja kakovosti za nadzor vseh faz proizvodnje medicinskih pripomočkov.
OPOMBA: Ta del standarda ISO 11137 ne zahteva, da je treba imeti popoln sistem vodenja kakovosti v fazi proizvodnje, toda elementi sistema vodenja kakovosti, ki so potrebni za izpolnjevanje minimalnih zahtev za nadzor sterilizacijskega postopka, so normativno navedeni na ustreznih mestih v besedilu (glej zlasti točko 4). Izpostavljeni so standardi za sisteme vodenja kakovosti (glej ISO 13485), ki nadzirajo vse faze proizvodnje medicinskih pripomočkov, vključno s sterilizacijskim postopkom. Regionalni in nacionalni predpisi za oskrbo z medicinskimi pripomočki lahko zahtevajo izvajanje celovitega sistema vodenja kakovosti in presojo tega sistema s strani tretje osebe.
1.2.3 Ta del standarda ISO 11137 ne zahteva, da se biološki kazalniki uporabljajo za validacijo ali spremljanje sterilizacije s sevanjem, niti ne zahteva, da se preskus farmakopeje za sterilnost izvaja ob začetku prodaje proizvodov.
1.2.4 Ta del standarda ISO 11137 ne določa zahtev za varnost pri delu, povezanih z načrtovanjem in upravljanjem sredstev za obsevanje.
OPOMBA: Izpostavljen je tudi obstoj, v nekaterih državah, uredb o varnostnih zahtevah za varnost pri delu v zvezi s sevanjem.
1.2.5 Ta del standarda ISO 11137 ne določa zahtev za sterilizacijo uporabljenih ali predelanih pripomočkov.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11137-1:2006
01-julij-2006
1DGRPHãþD
SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO =DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
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
© ISO 2006 – All rights reserved iii
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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.
© ISO 2006 – All rights reserved v
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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.
© ISO 2006 – All rights reserved 1
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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]
2 © ISO 2006 – All rights reserved
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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
© ISO 2006 – All rights reserved 3
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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(
...
EUROPEAN STANDARD
DRAFT
prEN ISO 11137-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2004
ICS
English version
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
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 204.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre 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, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11137-1:2004: E
worldwide for CEN national Members.
---------------------- Page: 1 ----------------------
prEN ISO 11137-1:2004 (E)
Foreword
This document (prEN ISO 11137-1:2004) 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 document is currently submitted to the parallel Enquiry.
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).
Endorsement notice
The text of ISO/DIS 11137-1:2004 has been approved by CEN as prEN ISO 11137-1:2004
without any modifications.
2
---------------------- Page: 2 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2004-04-29 2004-09-29
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
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
ICS 11.080.01
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2004
---------------------- Page: 3 ----------------------
ISO/DIS 11137-1
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Copyright notice
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Violators may be prosecuted.
©
ii ISO 2004 – All rights reserved
---------------------- Page: 4 ----------------------
Contents Page
Introduction.vii
1 Scope.1
1.1 Inclusions .1
1.2 Exclusions.1
2 Normative references .2
3 Terms and definitions .2
4 Quality management system elements .8
4.1 Documentation.8
4.2 Management responsibility .8
4.3 Product realization.8
4.4 Measurement, analysis and improvement – Control of nonconforming product.8
5 Sterilizing agent characterization .8
5.1 Sterilizing agent .8
5.2 Microbicidal effectiveness .8
5.3 Material effects.9
5.4 Environmental considerations .9
6 Process and equipment characterization .9
6.1 Process.9
6.2 Equipment .9
7 Product definition . 10
8 Process definition. 11
8.1 Establishing the maximum acceptable dose . 11
8.2 Establishing the sterilization dose. 11
8.3 Specifying the sterilization dose and the maximum acceptable dose. 12
8.4 Transference of maximum acceptable, verification or sterilization dose between radiation
sources . 12
8.4.1 Transference of maximum acceptable dose. 12
8.4.2 Transference of verification or sterilization dose . 12
9 Validation. 13
9.1 Installation qualification. 13
9.2 Operational qualification. 13
9.3 Performance qualification. 14
9.4 Review and approval of validation. 14
10 Routine monitoring and control. 15
11 Product release from sterilization. 16
12 Maintaining process effectiveness . 16
12.1 Demonstration of continued effectiveness. 16
12.2 Recalibration. 18
12.3 Maintenance of equipment . 19
12.4 Requalification of equipment . 19
12.5 Assessment of change. 19
Annex A (informative) Guidance. 20
A.1 Scope. 20
A.1.1 Inclusions . 20
A.1.2 Exclusions. 20
A.2 Normative references . 20
A.3 Terms and definitions . 20
A.4 Quality management system elements . 21
A.4.1 Documentation. 21
iv © ISO 2004 — All rights reserved
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A.4.2 Management responsibility .21
A.4.3 Product realization .22
A.4.4 Measurement, analysis and improvement – Control of nonconforming product.22
A.5 Sterilizing agent characterization .22
A.5.1 Sterilizing agent .22
A.5.2 Microbicidal effectiveness.23
A.5.3 Material effects.23
A.5.4 Environmental considerations .23
A.6 Process and equipment characterization .23
A.7 Product definition.23
A.8 Process definition.24
A.8.1 Establishing the maximum acceptable dose.24
A.8.2 Establishing the sterilization dose .24
A.8.3 Specifying the sterilization dose and the maximum acceptable dose.25
A.8.4 Transference of maximum acceptable, verification or sterilization dose between radiation
sources .25
A.9 Validation.25
A.9.1 Installation qualification.26
A.9.2 Operational qualification.26
A.9.3 Performance qualification.26
A.9.4 Review and approval of validation.26
A.10 Routine monitoring and control.26
A.11 Product release from sterilization.29
A.12 Maintaining process effectiveness .29
A.12.1 Demonstration of continued effectiveness.29
A.12.2 Recalibration.29
A.12.3 Maintenance of equipment .29
A.12.4 Requalification of equipment .30
A.12.5 Assessment of change.30
Bibliography.34
Annex ZA (normative) Normative references to international publications with their relevant
European publications.35
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC of 20 June 1990 concerning active implantable
medical devices, 93/42/EEC of 14 June 1993 concerning medical devices and 98/78/EC of 7
December 1988 concerning in vitro diagnostic medical devices.36
© ISO 2004 — All rights reserved v
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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 products.
This second edition cancels and replaces the first edition, which has been technically revised.
ISO 11137 consists of the following parts, under the general title Sterilization of health care products — Radiation:
⎯ Part 1: Requirements for the development, validation and routine control of a sterilization process for medical
products
⎯ Part 2: Establishing the sterilization dose
⎯ Part 3: Guidance on dosimetric aspects
vi © ISO 2004 — All rights reserved
---------------------- Page: 7 ----------------------
Introduction
A sterile medical device is one which 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
minimised. 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 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 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.
This standard describes requirements which will enable the demonstration that a radiation sterilization process
intended to sterilize medical devices has appropriate microbicidal activity, and that this activity is both reliable and
reproducible, such that the relationship for the inactivation of microorganisms can be extrapolated with reasonable
confidence to low levels of probability of there being a viable microorganism present on a product after sterilization.
This standard does not specify the maximal value to be taken by this probability; 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/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
sterilization processes used in manufacturing or reprocessing, the effectiveness of the sterilization process cannot
be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process.
For this reason, sterilization processes are validated for use, the performance of the sterilization process monitored
routinely and the equipment maintained.
Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with
the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use.
Attention is therefore given to a number of 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, and,
g) the conditions under which product is stored.
This International Standard 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 products treated with doses falling within
predetermined limits.
© ISO 2004 — All rights reserved vii
---------------------- Page: 8 ----------------------
The requirements are the normative parts of this standard with which compliance is claimed. The guidance given in
the informative annexes is not normative and is not provided as a check list for auditors. The guidance provides
explanations as well as methods that are accepted as being suitable means for complying with the requirements.
Approaches other than those given in the guidance may be used, if they are effective in achieving compliance with
the requirements of this International Standard.
The development, validation and routine control of a sterilization process comprise a number of discrete but
interrelated activities, for example calibration, maintenance, product definition, process definition, installation
qualification, operational qualification, and performance qualification. While the activities required by this standard
have been grouped together and are presented in a particular order; this International Standard does not require
that the activities be performed in the order that they are presented. The activities required are not necessarily
sequential, as the programs 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 International Standard does not specify the particular individuals or organizations to
carry out the activities.
viii © ISO 2004 — All rights reserved
---------------------- Page: 9 ----------------------
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 Inclusions
1.1.1 This International Standard specifies requirements for the development, validation and routine control of a
radiation sterilization process for medical devices.
NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance
that may be applicable to other products and equipment.
1.1.2 Radiation sterilization processes covered by this standard employ,
60 137
a) irradiators, using the radionuclides Co and Cs,
b) irradiators using a beam from an electron generator, or
c) irradiators using a beam from an x-ray generator.
1.2 Exclusions
1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standard
should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as
scrapie, bovine spongiform encephalopathy and Creutzfeld-Jacob disease. Specific recommendations have been
produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE (See, for example, EN 12442-1, -2 and -3).
1.2.2 This standard does not detail a specified requirement for designating a medical device as sterile.
NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for
example, EN 556-1 or ANSI/AAMI ST67.
1.2.3 This standard 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 standard to have a full 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 or reprocessing of medical devices, including the
sterilization process. National and/or regional regulations for the provision of medical devices might require a complete the
implementation of a full quality management system and the assessment of that system by a third party.
1.2.4 This standard does not require that biological indicators are used for validation or monitoring of radiation
sterilization, nor that a pharmacopoeial test for sterility is carried out for product release.
1.2.5 This standard does not specify requirements for occupational safety associated with the design and
operation of irradiation facil
...
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