EN ISO 25424:2011

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
ISO 25424:2009 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.
ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.

Sterilisation von Medizinprodukten - Niedertemperatur-Dampf- Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für Medizinprodukte (ISO 25424:2009)

1.1 Einbezogene Verfahren 1.1.1 Diese Europäische Norm legt Anforderungen für die Entwicklung, Validierung und Routine-
überwachung 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 für andere Produkte und Geräte gelten können.
1.1.2 Diese Europäische Norm ist dazu vorgesehen, von Verfahrensentwicklern, Herstellern von Sterilisa-
tionsausrüstungen, Herstellern zu sterilisierender Medizinprodukte und von Organisationen angewendet zu
werden, die Verantwortung für die Sterilisation von Medizinprodukten haben (siehe EN ISO 14937:2000,
Tabelle E.1).
1.1.3 Diese Europäische 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 Nicht in den Anwendungsbereich fallende Gesichtspunkte
1.2.1 Es sollte nicht vorausgesetzt werden, dass entsprechend den Anforderungen dieser Norm validierte und überwachte Sterilisationsverfahren bei der Inaktivierung der Verursacher spongiformer Enzephalopathien
wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit wirksam sind. In bestimm-
ten Ländern sind spezifische Empfehlungen für die Behandlung von möglicherweise mit diesen Erregern kontaminierten Materialien erarbeitet worden.
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 EN ISO 13485), die alle Stufen der Herstellung oder Wiederaufbereitung von Medizinprodukten einschließlich des Sterilisationsverfahrens lenken. Eine weitere Anleitung wird in EN ISO 14937:2000, E.2 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 EN 61010-2-040 festgelegt.
ANMERKUNG 2 Es wird auch darauf hingewiesen, dass in einigen Ländern Bestimmungen bestehen, in denen Sicher-
heitsanforderungen festgelegt sind.
1.2.5 Diese Europäische 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 Europäische Norm behandelt keine Vorbereitungsmaßnahmen, die vor der Sterilisation
erforderlich sein können wie Reinigung, Desinfektion und Verpackung.
ANMERKUNG Für wieder sterilisierbare Medizinprodukte sollten der bzw. die Hersteller dieser Produkte Angaben über die Vorbereitungsmaßnahmen zur Verfügung stellen (siehe EN ISO 17664).

Stérilisation des dispositifs médicaux - 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 25424:2009)

L'ISO 25424:2009 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 température basse (LTSF) pour les dispositifs médicaux.
L'ISO 25424:2009 est destinée à être appliquée 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 organisations responsables de la stérilisation des dispositifs médicaux.
L'ISO 25424:2009 couvre les procédés de stérilisation employant un mélange de vapeur et de formaldéhyde à température basse en tant que stérilisant et fonctionnant uniquement en dessous de la pression ambiante.

Sterilizacija medicinskih pripomočkov - Para nizke temperature in formaldehid - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 25424:2009)

Ta evropski standard določa zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskega postopka, ki uporablja paro nizke temperature in formaldehid (LTSF) za medicinske pripomočke. Ta evropski standard je namenjen razvijalcem postopkov, proizvajalcem sterilizacijske opreme, proizvajalcem medicinskih pripomočkov, ki se sterilizirajo, in organizacijam, odgovornim za sterilizacijo medicinskih pripomočkov. (Glej EN ISO 14937:2000, preglednica E.1) Ta evropski standard zajema sterilizacijske postopke, ki uporabljajo mešanico pare nizke temperature in formaldehida kot sterilanta in ki delujejo samo pod tlakom okolja.

General Information

• Status: Withdrawn
• Publication Date: 21-Jun-2011
• Withdrawal Date: 19-Nov-2019
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 20-Nov-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 25424:2011 - Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

Relations

• Replaces: EN 15424:2007 - Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
• Effective Date: 14-May-2011
• Replaced By: EN ISO 25424:2019 - 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)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2011
1DGRPHãþD
SIST EN 15424:2007
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY3DUDQL]NHWHPSHUDWXUHLQIRUPDOGHKLG
=DKWHYH]DUD]YRMYDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]D
PHGLFLQVNHSULSRPRþNH,62
Sterilization of medical devices - Low temperature steam and formaldehyde -
Requirements for development, validation and routine control of a sterilization process
for medical devices (ISO 25424:2009)
Sterilisation von Medizinprodukten - Niedertemperatur-Dampf- Formaldehyd -
Anforderungen an die Entwicklung, Validierung und Routineüberwachung von
Sterilisationsverfahren für Medizinprodukte (ISO 25424:2009)
Stérilisation des dispositifs médicaux - 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 25424:2009)
Ta slovenski standard je istoveten z: EN ISO 25424:2011
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 25424
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2011
ICS 11.080.01 Supersedes EN 15424:2007
English Version
Sterilization of medical devices - Low temperature steam and
formaldehyde - Requirements for development, validation and
routine control of a sterilization process for medical devices (ISO
25424:2009)
Stérilisation des dispositifs médicaux - Formaldéhyde et Sterilisation von Medizinprodukten - Niedertemperatur-
vapeur à faible température - Exigences pour le Dampf- Formaldehyd - Anforderungen an die Entwicklung,
développement, la validation et le contrôle de routine d'un Validierung und Routineüberwachung von
procédé de stérilisation pour dispositifs médicaux (ISO Sterilisationsverfahren für Medizinprodukte (ISO
25424:2009) 25424:2009)
This European Standard was approved by CEN on 3 June 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25424:2011: 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 .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

Foreword
The text of ISO 25424:2009 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
25424:2011 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 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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 15424:2007.
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 Annex ZA, ZB and ZC, which are integral parts of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 25424:2009 has been approved by CEN as a EN ISO 25424:2011 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 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 clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and 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 This relevant Essential Requirement is
only partly addressed in this European
Standard
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 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 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.
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 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 8.4
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 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 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.
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 This relevant Essential Requirement is
only partly addressed in this European
Standard
4,5,6,7,8,9,10,11,12 B.2.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

INTERNATIONAL ISO
STANDARD 25424
First edition
2009-09-01
Sterilization of medical devices — Low
temperature steam and formaldehyde —
Requirements for development, validation
and routine control of a sterilization
process for medical devices
Stérilisation des dispositifs médicaux — 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
Reference number
ISO 25424:2009(E)
©
ISO 2009
ISO 25424:2009(E)
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ISO 25424:2009(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 25424 was prepared by CEN (as EN 15424:2007) and is submitted for approval under a special “fast-
track procedure”, by Technical Committee ISO/TC 198, Sterilization of health care products, in parallel with its
approval by the ISO member bodies.
For the purposes of this International Standard, the CEN annex regarding the fulfilment of European Council
Directives has been removed.
ISO 25424:2009(E)
Contents Page
Foreword. vi
Introduction .
...