SIST EN ISO 25424:2020
(Main)Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
This Standard specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für Medizinprodukte (ISO 25424:2018)
1.1 In den Anwendungsbereich einbezogen
1.1.1 Diese Internationale Norm legt Anforderungen für die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens mit Niedertemperatur Dampf Formaldehyd (NTDF) für Medizin¬produkte fest.
ANMERKUNG Obgleich der Anwendungsbereich dieser Norm auf Medizinprodukte begrenzt ist, legt sie Anforderungen fest und liefert Anleitungen, die auch für andere Produkte und Geräte gelten können.
1.1.2 Diese Internationale Norm ist dazu vorgesehen, von Verfahrensentwicklern, Herstellern von Sterilisationsausrüstungen, Herstellern zu sterilisierender Medizinprodukte und von Organisationen angewendet zu werden, die Verantwortung für die Sterilisation von Medizinprodukten haben (siehe ISO 14937:2009, Tabelle E.1).
1.1.3 Diese Internationale Norm bezieht sich auf Sterilisationsverfahren, bei denen ein Gemisch von Niedertemperatur Dampf und Formaldehyd als Sterilisiermittel verwendet wird, und die nur unterhalb des Umgebungsdrucks betrieben werden.
1.2 In den Anwendungsbereich nicht einbezogen
1.2.1 Diese Internationale Norm spezifiziert keine Anforderungen für die Entwicklung, Validierung und Routinekontrolle für ein Verfahren zur Inaktivierung von Agenzien, welche spongiforme Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt Jakob Krankheit verursachen. In bestimm¬ten Ländern sind spezifische Empfehlungen für die Behandlung von möglicherweise mit diesen Erregern kontaminierten Materialien erarbeitet worden.
ANMERKUNG Siehe ISO 22442 1, ISO 22442 2 und ISO 22442 3.
1.2.2 Diese Norm legt keine Anforderungen zur Kennzeichnung eines Medizinprodukts als „STERIL“ fest. Solche Anforderungen sind in EN 556 1 angegeben.
1.2.3 Diese Norm legt kein Qualitätsmanagementsystem für die Überwachung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG Es ist keine Anforderung dieser Norm, dass ein vollständiges Qualitätsmanagementsystem während der Herstellung oder Wiederaufbereitung vorhanden ist, aber auf jene Elemente eines solchen Systems, die gefordert werden, erfolgen an den entsprechenden Stellen im Text normative Verweisungen. Zu beachten sind die Normen für Qualitätsmanagementsysteme (siehe ISO 13485), die alle Stufen der Herstellung oder Wiederaufbereitung von Medizinprodukten einschließlich des Sterilisationsverfahrens lenken. Eine weitere Anleitung wird in ISO 14937:2009, E.4 gegeben.
1.2.4 Diese Norm legt keine Anforderungen an den Arbeitsschutz fest, die mit Gestaltung und Betrieb von NTDF Sterilisationsanlagen zusammenhängen.
ANMERKUNG 1 Sicherheitsanforderungen für Sterilisatoren sind in IEC 61010 2 040 festgelegt.
ANMERKUNG 2 Es wird auch darauf hingewiesen, dass in einigen Ländern Bestimmungen bestehen, in denen Sicherheitsanforderungen festgelegt sind.
1.2.5 Diese Internationale Norm behandelt keine Analyseverfahren zur Bestimmung von Konzentrationen oder Rückständen von Formaldehyd und/oder dessen Reaktionsprodukten.
ANMERKUNG 1 Zu beachten ist EN 14180.
ANMERKUNG 2 Es wird darauf hingewiesen, dass in einigen Ländern möglicherweise Bestimmungen bestehen, in denen Grenzwerte für die Konzentration von Formaldehydrückständen auf Medizinprodukten und Produkten festgelegt sind.
1.2.6 Diese Internationale Norm behandelt keine Vorbereitungsmaßnahmen, die vor der Sterilisation erforderlich sein können wie Reinigung, Desinfektion und Verpackung.
ANMERKUNG Für wieder aufbereitbare Medizinprodukte kann/können der bzw. die Hersteller dieser Produkte Angaben über die Vorbereitungsmaßnahmen zur Verfügung stellen (siehe ISO 17664).
Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux (ISO 25424:2018)
1.1 Inclusions 1.1.1 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 à la vapeur et au formaldéhyde à basse température (LTSF, «Low Temperature Steam and Formaldehyde») pour les dispositifs médicaux, utilisant comme agent stérilisant un mélange à basse température de vapeur d'eau et de formaldéhyde et fonctionnant à une pression inférieure à la pression atmosphérique.
NOTE Bien que le domaine d'application du présent document se limite aux dispositifs médicaux, il spécifie les exigences et fournit des recommandations qui peuvent s'appliquer à d'autres produits et équipements.
1.1.2 Le présent document est destiné à être appliqué par les personnes chargées de la mise au point des procédés, les fabricants d'équipements de stérilisation, les fabricants de dispositifs médicaux destinés à être stérilisés et les organismes responsables de la stérilisation des dispositifs médicaux (voir l'ISO 14937:2009, Tableau E.1).
1.2 Exclusions 1.2.1 Le présent document ne spécifie pas les exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé permettant d'inactiver les agents responsables des encéphalopathies spongiformes telles que la tremblante du mouton, 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.
NOTE Voir l'ISO 22442‑1, l'ISO 22442‑2 et l'ISO 22442‑3.
1.2.2 Le présent document ne spécifie pas d'exigence pour qualifier un dispositif médical de «STÉRILE». De telles exigences sont fournies dans l'EN 556‑1.
1.2.3 Le présent document ne spécifie pas de système de management de la qualité pour le contrôle de l'ensemble des étapes de production des dispositifs médicaux.
NOTE Dans le présent document, il n'est pas exigé d'avoir un système complet de management de la qualité pour l'étape de fabrication ou de retraitement, mais les éléments exigés compris dans un système de ce type sont référencés de manière normative aux endroits appropriés dans le texte. 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 ou de retraitement des dispositifs médicaux, y compris le procédé de stérilisation. Des recommandations supplémentaires sont fournies dans l'ISO 14937:2009, E.4.
1.2.4 Le présent document ne spécifie aucune exigence en matière de sécurité au travail dans le cadre de la conception et du fonctionnement des installations de stérilisation LTSF.
NOTE 1 Les exigences de sécurité concernant les stérilisateurs sont spécifiées dans l'IEC 61010‑2‑040.
NOTE 2 L'attention est également attirée sur l'existence, dans certains pays, de réglementations établissant des exigences de sécurité.
1.2.5 Le présent document ne couvre pas les méthodes analytiques servant à déterminer les teneurs ou résidus de formaldéhyde et/ou de ses produits de réaction.
NOTE 1 L'attention est attirée sur l'EN 14180.
NOTE 2 L'attention est attirée sur la possibilité qu'il existe, dans certains pays, des réglementations statutaires établissant les limites de la teneur en résidus de formaldéhyde sur les produits et dispositifs médicaux.
1.2.6 Le présent document ne couvre pas les mesures préparatoires pouvant s'avérer nécessaires ava
Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 25424:2018)
Ta standard podaja zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov s paro nizke temperature in formaldehidom (LTSF) za medicinske pripomočke, pri katerih se kot sterilizacijsko sredstvo uporablja mešanica pare z nizko temperaturo in formaldehida ter ki potekajo pri nizkem zračnem tlaku. Ta dokument je namenjen uporabi s strani razvijalcev postopkov, proizvajalcev sterilizacijske opreme, proizvajalcev medicinskih pripomočkov, ki jih je treba sterilizirati, in organizacij, ki so odgovorne za sterilizacijo medicinskih pripomočkov (glej preglednico E.1 standarda ISO 14937:2009).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 25424:2020
01-februar-2020
Nadomešča:
SIST EN ISO 25424:2011
Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s
formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih
postopkov za medicinske pripomočke (ISO 25424:2018)
Sterilization of health care products - Low temperature steam and formaldehyde -
Requirements for development, validation and routine control of a sterilization process
for medical devices (ISO 25424:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-
Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung
von Sterilisationsverfahren für Medizinprodukte (ISO 25424:2018)
Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température -
Exigences pour le développement, la validation et le contrôle de routine d'un procédé de
stérilisation pour dispositifs médicaux (ISO 25424:2018)
Ta slovenski standard je istoveten z: EN ISO 25424:2019
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 25424:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 25424:2020
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SIST EN ISO 25424:2020
EN ISO 25424
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 25424:2011
English Version
Sterilization of health care products - Low temperature
steam and formaldehyde - Requirements for development,
validation and routine control of a sterilization process for
medical devices (ISO 25424:2018)
Stérilisation des produits de santé - Formaldéhyde et Sterilisation von Produkten für die
vapeur à faible température - Exigences pour le Gesundheitsfürsorge - Niedertemperatur-Dampf-
développement, la validation et le contrôle de routine Formaldehyd - Anforderungen an die Entwicklung,
d'un procédé de stérilisation pour dispositifs médicaux Validierung und Routineüberwachung von
(ISO 25424:2018) Sterilisationsverfahren für Medizinprodukte (ISO
25424:2018)
This European Standard was approved by CEN on 4 November 2019.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25424:2019 E
worldwide for CEN national Members.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Contents Page
European 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
[OJ L 189] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be
covered. 7
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices [OJ L
331] aimed to be covered . 9
Annex ZD (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 11
Annex ZE (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 14
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
European foreword
This document (EN ISO 25424:2019) 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 May 2020, and conflicting national standards shall be
withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 25424:2011 with a revised European Foreword and European
Annexes ZA, ZB and ZC, and additional European Annexes ZD and ZE.
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 the relationship with EU Directive(s) see informative Annex ZA, ZB, ZC, ZD or ZE, which is 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, ZC, ZD or ZE 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.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
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 11138-1:2017 EN ISO 11138-1:2017 ISO 11138-1:2017
ISO 11138-5:2017 EN ISO 11138-5:2017 ISO 11138-5:2017
ISO 11140-1:2014 EN ISO 11140-1:2014 ISO 11140-1:2014
ISO 11737-1 EN ISO 11737-1:2006 ISO 11737-1:2006
ISO 11737-2:2009 EN ISO 11737-2:2009 ISO 11737-2:2009
NOTE One standard normatively referred to by EN ISO 25424:2019 is undated. The referred standards also
include normative references to other dated and undated standards. For undated normative references, it should
always be assumed that the latest edition applies.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 25424:2018 has been approved by CEN as EN ISO 25424:2019 without any modification.
4
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical
devices [OJ L 189] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request
M/BC/CEN/89/9 to provide one voluntary means of conforming to essential requirements of Council
Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating
to active implantable medical devices [OJ L 189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 10of 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.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
90/385/EEC [OJ L 189]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 90/385/EEC
7 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the development,
validation and routine control of a
sterilization process using low
temperature steam and
formaldehyde for medical devices,
including requirements that the
sterilized medical device is safe and
performs as intended after
sterilization. This Essential
Requirement is addressed only with
regard to devices for which
sterilization by low temperature
steam and formaldehyde is
appropriate.
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 by low
temperature steam and
formaldehyde are not covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169]
aimed to be covered
This European Standard has been prepared under a Commission's standardization request
M/BC/CEN/89/9 to provide one voluntary means of conforming to essential requirements of Council
Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 ZB 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 ZB.1, it means that it is not addressed by this
European Standard.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Table ZB.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 93/42/EEC
8.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the development,
validation and routine control of a
sterilization process using low
temperature steam and
formaldehyde for medical devices,
including requirements that the
sterilized medical device is safe and
performs as intended after
sterilization. This Essential
Requirement is addressed only with
regard to devices for which
sterilization by low temperature
steam and formaldehyde is
appropriate.
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 by low
temperature steam and
formaldehyde are not covered.
8.4 4,5,6,7,8,9,10,11,12 This relevant Essential Requirement
is only partly addressed in this
European Standard. This Essential
Requirement is addressed only with
regard to devices for which
sterilization by low temperature
steam and formaldehyde is
appropriate. Aspects of manufacture
other than those related to
sterilization by low temperature
steam and formaldehyde are not
covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices [OJ L 331] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request, M/252,
concerning the development of European standards relating to in vitro diagnostic medical devices, to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [OJ L
331].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 7of the Directive.
NOTE 3 This Annex ZC 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 ZC.1, it means that it is not addressed by this
European Standard.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Table ZC.1 — Correspondence between this European Standard and Annex I of Directive
98/79/EC [OJ L 331]
Essential Requirements (ERs) of Clauses of this EN Qualifying remarks/Notes
Directive 98/79/EC
B.2.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the development,
validation and routine control of a
sterilization process using low
temperature steam and
formaldehyde for medical devices,
including requirements that the
sterilized medical device is safe and
performs as intended after
sterilization. This Essential
Requirement is addressed only with
regard to devices for which
sterilization by low temperature
steam and formaldehyde is
appropriate.
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 by low
temperature steam and
formaldehyde are not covered.
Other special microbiological states
are not covered.
B.2.4 4,5,6,7,8,9,10,11,12 This relevant Essential requirement
is addressed only with regard to:
- sterilization, not covering other
special microbiological states
- devices for which sterilization by
low temperature steam and
formaldehyde is appropriate
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Annex ZD
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZD.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, 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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZD 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 a General Safety and Performance Requirement does not appear in Table ZD.1, it means that it is
not addressed by this European Standard.
Table ZD.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/745
11.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the medical
device is safe and performs as
intended after treatment. It could
also be applied to the
development, validation and
routine control of a process for
attainment of a specific microbial
11
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
state other than sterility. This
General Safety and Performance
Requirement is addressed only
with regard to devices for which
treatment by low temperature
steam and formaldehyde is
appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of a specific
microbial state during
transportation and storage are not
covered. Aspects of manufacture
other than those related to
attainment of a specific microbial
state by low temperature steam
and formaldehyde are not
covered.
11.4 first sentence only 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the sterilized
medical device is safe and
performs as intended after
sterilization. This General Safety
and Performance Requirement is
addressed only with regard to
devices for which sterilization by
low temperature steam and
formaldehyde is appropriate.
This relevant General Safety and
Performance 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
attainment of sterility by low
temperature steam and
formaldehyde are not covered.
Evidence that the integrity of the
packaging is maintained to the
point of use is not covered.
11.5 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
12
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
medical devices, including
requirements that the sterilized
medical device is safe and
performs as intended after
sterilization. This General Safety
and Performance Requirement is
addressed only with regard to
devices for which sterilization by
low temperature steam and
formaldehyde is appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Packaging for
maintenance of sterility are not
covered. Aspects of manufacture
other than those related to
attainment of sterility by low
temperature steam and
formaldehyde are not covered.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
13
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
Annex ZE
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/746 of 5 April 2017 concerning in vitro diagnostic medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZE.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, 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 Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 This Annex ZE 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 a General Safety and Performance Requirement does not appear in Table ZE.1, it means that it is
not addressed by this European Standard.
Table ZE.1 – Correspondence between this European standard and Annex I of Regulation (EU)
2017/746 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/746
11.2 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the medical
device is safe and performs as
intended after treatment. It could
also be applied to the
development, validation and
routine control of a process for
attainment of a specific microbial
14
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SIST EN ISO 25424:2020
EN ISO 25424:2019 (E)
state other than sterility. This
General Safety and Performance
Requirement is addressed only
with regard to devices for which
treatment by low temperature
steam and formaldehyde is
appropriate.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging
for maintenance of a sterility or
another specific microbial state
during transportation and storage
are not covered. Aspects of
manufacture other than those
related to attainment of sterility or
another specific microbial state by
low temperature steam and
formaldehyde are not covered.
11.3 4,5,6,7,8,9,10,11,12 This standard provides
requirements for the
development, validation and
routine control of a sterilization
process using low temperature
steam and formaldehyde for
medical devices, including
requirements that the sterilized
medical device is safe and
performs as intended after
sterilization. This General Safety
and Performance Requirement is
addressed only with regard to
devices for which
...
SLOVENSKI STANDARD
oSIST prEN ISO 25424:2017
01-marec-2017
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR3DUD]QL]NRWHPSHUDWXURLQV
IRUPDOGHKLGRP=DKWHYH]DUD]YRMYDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLK
SRVWRSNRY]DPHGLFLQVNHSULSRPRþNH ,62',6
Sterilization of health care products - Low temperature steam and formaldehyde -
Requirements for development, validation and routine control of a sterilization process
for medical devices (ISO/DIS 25424:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-
Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung
von Sterilisationsverfahren für Medizinprodukte (ISO/DIS 25424:2017)
Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température -
Exigences pour le développement, la validation et le contrôle de routine d'un procédé de
stérilisation pour dispositifs médicaux (ISO/DIS 25424:2017)
Ta slovenski standard je istoveten z: prEN ISO 25424
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 25424:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 25424:2017
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oSIST prEN ISO 25424:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 25424
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-01-12 2017-04-05
Sterilization of health care products — Low temperature
steam and formaldehyde — Requirements for
development, validation and routine control of a
sterilization process for medical devices
Stérilisation des produits de santé — Formaldéhyde et vapeur à faible température — Exigences pour
le développement, la validation et le contrôle de routine d’un procédé de stérilisation pour dispositifs
médicaux
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 25424:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017
---------------------- Page: 3 ----------------------
oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
Contents Page
Foreword .v
Introduction .vi
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 . 9
4.4 Control of non-conforming product. 9
5 Sterilizing agent characterization . 9
5.1 General . 9
5.2 Sterilizing agent . 9
5.3 Microbicidal effectiveness .10
5.4 Material effects.10
5.5 Environmental considerations .10
6 Process and equipment characterization .10
6.1 General .10
6.2 Process .10
6.3 Equipment .11
7 Product definition .11
8 Process definition .12
9 Validation .13
9.1 General .13
9.2 Installation qualification .14
9.2.1 General.14
9.2.2 Installation .14
9.2.3 Equipment .14
9.3 Operational qualification .15
9.4 Performance qualification .15
9.4.1 General.15
9.4.2 Performance qualification – physical .16
9.4.3 Performance qualification – microbiological .16
9.4.4 Performance qualification – desorption and drying .16
9.5 Review and approval of validation .17
10 Routine monitoring and control .18
10.1 General .18
10.2 Biological indicators .18
10.3 Chemical indicators .18
10.4 Records .18
11 Product release from sterilization .19
12 Maintaining process effectiveness .19
12.1 General .19
12.2 Maintenance of equipment .19
12.3 Requalification .19
12.4 Assessment of change .20
© ISO 2017 – All rights reserved iii
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
Annex A (normative) Process definition based on inactivation of reference microorganisms
and knowledge of bioburden on product items to be sterilized .21
Annex B (normative) Process definition based on inactivation of reference microorganisms .22
Annex C (informative) Guidance on application of this International Standard .25
Annex D (informative) Environmental aspects regarding development, validation and
routine control of Low Temperature Steam and Formaldehyde processes.35
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices .40
Bibliography .41
iv © ISO 2017 – All rights reserved
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is Technical Committee ISO/TC 198, Sterilization of health
care products.
This second edition cancels and replaces the first edition (ISO 25424:2009), which has been technically
revised.
For the purposes of this International Standard, the CEN annex regarding the fulfilment of European
Council Directives has been removed.
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
Introduction
A sterile medical device is one which is free of viable microorganisms. International Standards, which
specify requirements for validation and routine control of a sterilization process 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 ISO 13485) or which have been subjected to a cleaning process as part of their reprocessing in
a health care establishment 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
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 if met, will demonstrate that a low temperature steam
and formaldehyde 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
given in EN 556-1.
Requirements of the quality management system for medical device design/development, production,
installation and servicing are given in ISO 13485. The standard for quality management systems
recognizes that, for certain processes used in manufacturing or reprocessing, the effectiveness 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 the product is transported and stored.
The type of contamination on a product to be sterilized varies and this impacts upon the effectiveness
of a sterilization process. Products that have been used in a health care setting and are being presented
for reprocessing in accordance with the manufacturer’s instructions (see ISO 17664) should be regarded
as a special case. There is the potential for such products to possess a wide range of contaminating
microorganisms and residual inorganic and/or organic contamination in spite of the application of a
vi © ISO 2017 – All rights reserved
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
cleaning process. Hence, particular attention has to be given to the validation and control of the cleaning
and disinfection processes used during reprocessing.
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 checklist 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 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
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
Standard does not specify the particular individuals or organizations to carry out the activities.
Activities required by this standard could also give rise to an environmental burden that can be
considered and minimized, e.g. by utilizing flexibility in planning. Environmental aspects are addressed
in Annex D of this standard.
© ISO 2017 – All rights reserved vii
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oSIST prEN ISO 25424:2017
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oSIST prEN ISO 25424:2017
DRAFT INTERNATIONAL STANDARD ISO/DIS 25424:2017(E)
Sterilization of health care products — Low temperature
steam and formaldehyde — 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 Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and
provides guidance that can be applicable to other products and equipment.
1.1.2 This International Standard is intended to be applied by process developers, manufacturers of
sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with
responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.1.3 This International Standard covers sterilization processes which use a mixture of low
temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
1.2 Exclusions
1.2.1 This International Standard does not specify requirements for the 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. Specific recommendations
have been produced in particular countries for the processing of materials potentially contaminated with
these agents.
NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This standard does not specify requirements for designating a medical device as “STERILE”. Such
requirements are given in EN 556-1.
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 complete quality management system during
manufacture or reprocessing, but those elements of such a system that are required are normatively referenced
at appropriate places in the text. 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. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4 This standard does not specify requirements for occupational safety associated with the design
and operation of LTSF sterilization facilities.
NOTE 1 Safety requirements for sterilizers are specified in IEC 61010-2-040.
NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety
requirements.
© ISO 2017 – All rights reserved 1
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
1.2.5 This International Standard does not cover analytical methods for determining levels or residues
of formaldehyde and/or its reaction products.
NOTE 1 Attention is drawn to EN 14180.
NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation
specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6 This International Standard does not cover preparatory measures that might be necessary before
sterilization such as cleaning, disinfection and packing.
NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on
the preparatory measures (see ISO 17664).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 14180:2014, Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers —
Requirements and testing
ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-5:2006, Sterilization of health care products — Biological indicators — Part 5: Biological
indicators for low-temperature steam and formaldehyde sterilization processes
ISO 11140, Sterilization of health care products — Chemical indicators
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 11737-2:2009, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization process
ISO 13485, 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
aeration
part of the sterilization process during which sterilizing agent and/or its reaction products desorb from
the medical device until predetermined levels are reached
Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room.
[SOURCE: EN 14180:2014, 3.2]
3.2
air removal
removal of air from the sterilizer chamber and sterilization load to facilitate sterilant penetration
[SOURCE: EN 14180:2014, 3.3]
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oSIST prEN ISO 25424:2017
ISO/DIS 25424:2017(E)
3.3
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO/TS 11139:2006, 2.2]
3.4
biological indicator
BI
test system containing viable microorganisms providing a defined resistance to a specified
sterilization process
[SOURCE: ISO/TS 11139:2006, 2.4]
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values 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
[SOURCE: ISO/TS 11139:2006, 2.4]
3.6
change control
assessment and determination of the appropriateness of a proposed alteration to product or procedure
[SOURCE: ISO/TS 11139:2006, 2.5]
3.7
chemical indicator
combination of the indicator agent and its substrate that reveals change in one or more process
variables based on a chemical or physical change resulting from exposure to a process
Note 1 to entry: An indicator intended to be used only in combination with a specific test load is also termed an
indicator (both together becoming an indic
...
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