EN ISO 11137-1:2015
(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, including Amd 1:2013)
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, including Amd 1:2013)
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;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
1.1 Dieser Teil von ISO 11137 legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung 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 normative Verweisungen angeführt (siehe im Besonderen Abschnitt 4). Zu beachten sind die Normen über Qualitäts-managementsysteme (siehe ISO 13485), die alle Stufen der Herstellung oder Aufbereitung von Medizinprodukten lenken einschließlich des Sterilisations¬verfahrens. Regionale und nationale Bestimmungen für die Bereitstellung von Medizinprodukten könnten die Durchsetzung eines vollständigen Qualitätsmanagementsystems und die Beurteilung dieses Systems durch eine dritte Seite fordern.
1.2.3 Dieser Teil von ISO 11137 fordert nicht den Einsatz biologischer Indikatoren für die Validierung oder Lenkung der Strahlensterilisation oder dass für die Produktfreigabe eine Prüfung auf Sterilität nach einem Arzneibuch durchgeführt wird.
1.2.4 Dieser Teil von ISO 11137 legt keine Anforderungen an den Arbeitsschutz fest, die mit dem Design und dem Betrieb von Bestrahlungsanlagen zusammenhängen.
ANMERKUNG Es wird auch darauf aufmerksam gemacht, dass in einigen Ländern Vorschriften bestehen, die Sicherheitsanforderungen für den mit der Bestrahlung zusammenhängenden Arbeitsschutz festlegen.
1.2.5 Dieser Teil von ISO 11137 legt keine Anforderungen für die Sterilisation gebrauchter oder wiederaufbereiteter Medizinprodukte fest.
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux (ISO 11137-1:2006, y compris Amd 1:2013)
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, vključno z dopolnilom Amd 1:2013)
Standard ISO 11137-1:2006 določa zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskega postopka s sevanjem za medicinske pripomočke. Čeprav se je obseg standarda ISO 11137-1: 2006 omejena na medicinske pripomočke, določa zahteve in smernice, ki se lahko uporabljajo za druge izdelke in opremo.
Standard ISO 11137-1:2006 zajema postopke sevanja z iradiatorji z uporabo radionuklidov 60Co ali 137Cs, žarka iz generatorja elektronov ali žarka iz generatorja rentgenskega sevanja.
Standard ISO 11137-1:2006 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; zahtev za označevanje medicinskega pripomočka kot sterilnega; sistema vodenja kakovosti za nadzor vseh faz proizvodnje medicinskih pripomočkov; zahtev za varnost pri delu, povezanih z načrtovanjem in upravljanjem sredstev za obsevanje; zahtev za sterilizacijo uporabljenih ali predelanih pripomočkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
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SIST EN ISO 11137-1:2006
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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, including Amd 1:2013)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte
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 11137-1:2006, y compris Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 11137-1:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11137-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.080.01 Supersedes EN ISO 11137-1:2006
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,
including Amd 1:2013)
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, y compris Amd Sterilisationsverfahrens für Medizinprodukte (ISO 11137-
1:2013) 1:2006, einschließlich Amd 1:2013)
This European Standard was approved by CEN on 20 May 2015.
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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-1:2015 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices .5
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .6
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .7
Foreword
The text of ISO 11137-1:2006, including Amd 1:2013 has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO 11137-1:2015 by 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 December 2015, and conflicting national standards shall be withdrawn
at the latest by December 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11137-1:2006.
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 Directives.
For relationship with EU Directives, see informative Annexes ZA, ZB, ZC, which are an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below applies. For
dated references, only the edition cited applies. However, for any use of this standard within the meaning of
Annex ZA, ZB or ZC, the user should always check that any referenced document has not been superseded
and that its relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the
ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10012-1 EN ISO 10012:2003 ISO 10012:2003
ISO 11137-2 EN ISO 11137-2:2013 ISO 11137-2:2013
ISO 11737-1 EN ISO 11737-1:2006 + AC:2009 ISO 11737-1:2006 + Cor 1:2007
ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009
ISO 13485 EN ISO 13485:2012 ISO 13485:2003
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11137-1:2006, including Amd 1:2013 has been approved by CEN as EN ISO 11137-1:2015
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable
medical devices
This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that risks
have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according
to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements
1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this Standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN/CENELC by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union 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 ZB.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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that risks have
to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the
wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements
1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
4,5,6,7,8,9,10,11,12 8.3 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.
4,5,6,7,8,9,10,11,12 8.4 This relevant Essential
Requirement is only partly
addressed in this European
Standard. Aspects of manufacture
other than those related to
sterilization are not covered.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this Standard.
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic
medical devices
This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union 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 ZC.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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 98/79/EC. This means that risks have to be reduced ‘as far as
possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the
corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements
Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 B.2.3 Only a sterilization process using
ionizing radiation is considered by
this standard.
This relevant Essential
Requirement is only partly
addressed in this European
Standard. Design and packaging
for maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
sterilization are not covered.
4,5,6,7,8,9,10,11,12 B.2.4 This relevant Essential requirement
is addressed only with regard to:
- sterilization, not covering other
special microbiological state
- devices for which sterilization by
radiation is appropriate
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this Standard.
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
ISO 11137-1:2006(E)
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ii © ISO 2006 – All rights reserved
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 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
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 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
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 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
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
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 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(s)
medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including
biopharmaceutical(s)
[ISO/TS 11139:2006]
3.16
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[ISO/TS 11139:2006]
3.17
irradiation container
holder in which product is transported through the irradiator
NOTE The holder can be a carrier, cart, tray, product carton, pallet or other container.
3.18
irradiator operator
company or body responsible for irradiation of product
3.19
maximum acceptable dose
dose given in the process specification as the highest dose that can be applied to a defined product without
compromising safety, quality or performance
4 © ISO 2006 – All rights reserved
ISO 11137-1:2006(E)
3.20
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in combination,
for human beings for one or more of the specific purpose(s) of:
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease;
⎯ diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
⎯ investigation, replacement, modification, or support of the anatomy or of a physiological process;
⎯ supporting or sustaining life;
⎯ control of conception;
⎯ disinfection of medical devices;
⎯ providing information for medical purposes by means of in vitro examination of specimens derived
from the human body;
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[ISO 13485:2003]
NOTE This definition from ISO 13485:2003 has been developed by the Global Harmonization Task Force
(GHTF 2002).
3.21
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
NOTE A specific standard might not require demonstration of the effectiveness of the sterilization process in
inactivating all types of microorganisms, identified in the definition above, for validation and/or routine control of the
sterilization process.
[ISO/TS 11139:2006]
3.22
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures
[ISO/TS 11139:2006]
3.23
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance
with operational procedures, consistently performs in accordance with predetermined criteria and thereby
yields product meeting its specification
[ISO/TS 11139:2006]
ISO 11137-1:2006(E)
3.24
preventive action
action to eliminate the cause of a potential nonconformity or other undesirable potential situation
NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas “corrective action” (3.7) is taken to prevent
recurrence.
[ISO 9000:2005]
3.25
primary manufacturer
body responsible for the design and manufacture of a medical device, together with the safety and
performance of that medical device when placed on the market
3.26
process interruption
intentional or unintentional stoppage of the irradiation process
3.27
process parameter
specified value for a process variable
NOTE The specification for a sterilization process includes the process parameters and their tolerances.
[ISO/TS 11139:2006]
3.28
process variable
condition within a sterilization process, changes in which alter microbicidal effectiveness
EXAMPLES Time, temperature, pressure, concentration, humidity, wavelength.
3.29
processing category
group of different product that can be sterilized together
NOTE Processing categories can be based on, for instance, composition, density or dose requirements.
3.30
product
result of a process
[ISO 9000:2005]
NOTE For the purposes of sterilization standards, product is tangible and can be raw material(s), intermediate(s),
sub-assembly(ies) or health care product(s).
3.31
product family
group of different product that can be given the same sterilization dose
3.32
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified process
[ISO/TS 11139:2006]
6 © ISO 2006 – All rights reserved
ISO 11137-1:2006(E)
3.33
services
supplies from an external source, needed for the function of equipment
EXAMPLES Electricity, water, compressed air, drainage.
3.34
specification
approved document stipulating requirements
3.35
specify
stipulate in detail within an approved document
[ISO/TS 11139:2006]
3.36
sterile
free from viable microorganisms
[ISO/TS 11139:2006]
3.37
sterility
s
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