kSIST FprEN ISO 11137-1:2025
(Main)Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024)
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024)
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO/FDIS 11137‑1:2024)
1.1 Dieses Dokument legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung eines Strahlensterilisationsverfahrens für Medizinprodukte fest.
ANMERKUNG Obgleich der Anwendungsbereich auf Medizinprodukte begrenzt ist, kann dieses Dokument auch auf andere Produkte und Ausrüstungen angewendet werden.
Durch dieses Dokument erfasste Strahlensterilisationsverfahren wenden Bestrahlungsanlagen an:
a) die die Radionuklide 60Co oder 137Cs verwenden,
b) in denen beschleunigte Elektronen erzeugt werden, oder
c) in denen X-Rays (Röntgenstrahlen) erzeugt werden.
1.2 Dieses Dokument ist nicht anwendbar auf Verfahren zur Inaktivierung von Viren oder Verursachern spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalitis und Creutzfeldt-Jakob-Krankheit.
ANMERKUNG Informationen zu solchen Verfahren finden sich in ISO 22442 1, ISO 22442 2, ISO 22442 3, ISO 13022 und ICH Q5A.
1.2.1 Dieses Dokument legt keine Anforderungen zur Kennzeichnung eines Medizinprodukts als steril fest.
ANMERKUNG Regionale und nationale Anforderungen können Medizinprodukte als steril kennzeichnen. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
1.2.2 Dieses Dokument legt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG Es ist keine Anforderung dieses Dokuments, dass bei der Herstellung ein vollständiges Qualitätsmanagementsystem vorhanden ist, aber die als Minimum erforderlichen Elemente eines Qualitätsmanagementsystems zur Lenkung des Sterilisationsverfahrens werden an geeigneten Stellen im Text als normative Verweisungen angeführt (siehe im Besonderen Abschnitt 4). Zu beachten sind die Normen über Qualitätsmanagementsysteme (siehe ISO 13485), die alle Stufen der Herstellung von Medizinprodukten lenken einschließlich des Sterilisationsverfahrens. Regionale und nationale Bestimmungen für die Bereitstellung von Medizinprodukten können die Umsetzung eines vollständigen Qualitätsmanagementsystems und die Beurteilung dieses Systems durch eine dritte Seite erfordern.
1.2.3 Dieses Dokument fordert nicht den Einsatz biologischer Indikatoren für die Validierung oder Lenkung der Strahlensterilisation oder dass für die Produktfreigabe eine Prüfung auf Sterilität nach einem Arzneibuch durchgeführt wird.
1.2.4 Dieses Dokument legt keine Anforderungen an den Arbeitsschutz fest, die mit dem Design und dem Betrieb von Bestrahlungsanlagen zusammenhängen.
ANMERKUNG In einigen Ländern gibt es Vorschriften über Sicherheitsanforderungen für den Arbeitsschutz im Zusammenhang mit Bestrahlung.
1.2.5 Dieses Dokument legt keine Anforderungen für die Sterilisation gebrauchter oder wiederaufbereiteter Medizinprodukte fest.
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux (ISO/FDIS 11137-1:2024)
1.1 Le présent document spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine d’un procédé de stérilisation par irradiation pour les dispositifs médicaux.
NOTE Bien que le domaine d’application se limite aux dispositifs médicaux, le présent document peut être applicable à d’autres produits et équipements.
Le présent document couvre les procédés d’irradiation utilisant des irradiateurs, qui utilisent:
a) les radionucléides 60Co ou 137Cs;
b) un faisceau à partir d’un générateur d’électrons; ou
c) un faisceau à partir d’un générateur de rayons X.
1.2 Le présent document n’est pas applicable aux procédés d’inactivation des virus ou des agents responsables des encéphalopathies spongiformes telles que la tremblante du mouton, l’encéphalopathie spongiforme bovine et la maladie de Creutzfeldt-Jakob.
NOTE Pour plus d’informations sur ces procédés, voir l’ISO 22442-1, l’ISO 22442-2, l’ISO 22442-3, l’ISO 13022 et l’ICH Q5A.
1.2.1 Le présent document ne spécifie pas les exigences relatives à la désignation d’un dispositif médical stérile.
NOTE Les exigences régionales et nationales peuvent désigner des dispositifs médicaux stériles. Voir, par exemple, l’EN 556-1 ou l’ANSI/AAMI ST67.
1.2.2 Le présent document ne spécifie pas de système de management de la qualité pour le contrôle de toutes les étapes de production des dispositifs médicaux.
NOTE Il n’est pas exigé par le présent document d’avoir un système de management de la qualité complet durant la fabrication, mais les éléments d’un système de management de la qualité qui sont au minimum nécessaire pour contrôler le procédé de stérilisation sont référencés aux endroits appropriés dans le texte (voir en particulier l’Article 4). L’attention est attirée sur les normes relatives aux systèmes de management de la qualité (voir l’ISO 13485) qui contrôlent toutes les étapes de production des dispositifs médicaux, y compris le procédé de stérilisation. Les réglementations régionales et/ou nationales pour la fourniture de dispositifs médicaux peuvent exiger la mise en place d’un système de management de la qualité complet et l’évaluation de ce système par une tierce partie.
1.2.3 Le présent document n’exige ni l’utilisation d’indicateurs biologiques pour la validation ou la surveillance de la stérilisation par irradiation, ni qu’un essai de stérilité défini dans la pharmacopée soit réalisé pour la libération du produit.
1.2.4 Le présent document ne spécifie pas d’exigences relatives à la sécurité du travail associée à la conception et au fonctionnement des installations d’irradiation.
NOTE Dans certains pays, il peut exister des réglementations sur les exigences relatives à la sécurité au travail liée aux radiations.
1.2.5 Le présent document ne spécifie pas d’exigences relatives à la stérilisation de dispositifs usagés ou retraités.
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO/FDIS 11137-1:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 11137-1:2023
01-junij-2023
Sterilizacija izdelkov za zdravstveno nego - Sevanje - 1. del: Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 11137-1:2023)
Sterilization of health care products - Radiation - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices (ISO/DIS
11137-1:2023)
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11137-1:2023)
Stérilisation des produits de santé - Irradiation - Partie 1: Exigences relatives à la mise
au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les
dispositifs médicaux (ISO/DIS 11137-1:2023)
Ta slovenski standard je istoveten z: prEN ISO 11137-1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11137-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 11137-1:2023
oSIST prEN ISO 11137-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-14 2023-07-07
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
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oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11137-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Sterilization of health care products — Radiation —
Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General . 9
5 Sterilizing agent characterization .10
5.1 Sterilizing agent . 10
5.2 Microbicidal effectiveness . . 10
5.3 Material effects . 10
5.4 Environmental considerations . 10
6 Process and equipment characterization .10
6.1 Process . 10
6.2 Equipment . 10
7 Product definition .12
8 Process definition .12
8.1 Establishing the maximum acceptable dose, D .12
max,acc
8.2 Establishing the sterilization dose, D . 13
ster
8.3 Specifying the maximum acceptable dose and the sterilization dose .13
8.4 Transference of maximum acceptable, verification or sterilization dose between
radiation sources .13
8.4.1 Transference of maximum acceptable dose .13
8.4.2 Transference of verification dose or sterilization dose . 14
9 Validation . .14
9.1 Installation qualification . 14
9.2 Operational qualification . 14
9.3 Performance qualification.15
9.4 Review and approval of validation . 16
10 Routine monitoring and control.17
11 Product release from sterilization .17
12 Maintaining process effectiveness .18
12.1 Demonstration of continued effectiveness . 18
12.1.1 General . 18
12.1.2 Frequency of determinations of bioburden . 18
12.1.3 Frequency of sterilization dose audits . 18
12.2 Recalibration . 20
12.3 Maintenance of equipment . 20
12.4 Requalification . 20
12.5 Assessment of change . 20
Annex A (informative) Guidance .21
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .36
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered .40
Bibliography .43
iii
oSIST prEN ISO 11137-1:2023
ISO/DIS 11137-1:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
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