SIST EN ISO 25424:2011
(Main)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)
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)
This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. This European 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 EN ISO 14937:2000, Table E.1) This European Standard covers sterilization processes which 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.
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 sp�cifie les exigences relatives � la mise au point, � la validation et au contr�le de routine d'un proc�d� de st�rilisation � la vapeur et au formald�hyde � temp�rature basse (LTSF) pour les dispositifs m�dicaux.
L'ISO 25424:2009 est destin�e � �tre appliqu�e par les personnes charg�es de la mise au point des proc�d�s, les fabricants d'�quipements de st�rilisation, les fabricants de dispositifs m�dicaux destin�s � �tre st�rilis�s et les organisations responsables de la st�rilisation des dispositifs m�dicaux.
L'ISO 25424:2009 couvre les proc�d�s de st�rilisation employant un m�lange de vapeur et de formald�hyde � temp�rature basse en tant que st�rilisant 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 25424:2011
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
SIST EN ISO 25424:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 25424:2011
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SIST EN ISO 25424:2011
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.
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SIST EN ISO 25424:2011
EN ISO 25424:2011 (E)
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
2
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SIST EN ISO 25424:2011
EN ISO 25424:2011 (E)
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.
3
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SIST EN ISO 25424:2011
EN ISO 25424:2011 (E)
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.
4
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SIST EN ISO 25424:2011
EN ISO 25424:2011 (E)
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.
5
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SIST EN ISO 25424:2011
EN ISO 25424:2011 (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
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.
6
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SIST EN ISO 25424:2011
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
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SIST EN ISO 25424:2011
ISO 25424:2009(E)
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ii © ISO 2009 – All rights reserved
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SIST EN ISO 25424:2011
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 2009 – All rights reserved iii
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SIST EN ISO 25424:2011
ISO 25424:2009(E)
Contents Page
Foreword. vi
Introduction . vii
1 Scope .1
1.1 Inclusions .1
1.2 Exclusions .1
2 Normative references .2
3 Terms and definitions .2
4 Quality management system elements .8
4.1 Documentation.8
4.2 Management responsibility .8
4.3 Product realization.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 .9
5.4 Material effects.9
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.13
9.3 Operational qualification.14
9.4 Performance qualification.15
9.5 Review and approval of validation.16
10 Routine monitoring and control.17
10.1 General.17
10.2 Biological indicators .17
10.3 Chemical indicators.18
10.4 Records.18
11 Product release from sterilization.18
12 Maintaining process effectiveness .18
12.1 General.18
12.2 Maintenance of equipment .18
12.3 Requalification .19
12.4 Assessment of change.19
Annex A (normative) Process definition based on inactivation of reference microorganisms and
knowledge of bioburden on product items to be sterilized .20
Annex B (normative) Process definition based on inactivation of reference microorganisms.21
iv © ISO 2009 – All rights reserved
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SIST EN ISO 25424:2011
ISO 25424:2009(E)
Annex C (informative) Guidance on application of this European Standard.23
Annex D (informative) Environmental aspects regarding development, validation and routine
control of Low Temperature Steam and Formaldehyde processes.33
Bibliography.37
© ISO 2009 – All rights reserved v
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SIST EN ISO 25424:2011
ISO 25424:2009(E)
Foreword
This document (EN 15424:2007) has been prepared 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 October 2007, and conflicting national standards shall be withdrawn at
the latest by October 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 Directive(s).
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, 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.
vi © ISO 2009 – All rights reserved
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SIST EN ISO 25424:2011
ISO 25424:2009(E)
Introduction
A sterile medical device is one which is free of viable microorganisms. European 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 EN 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 will enable the demonstration 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 EN 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.
© ISO 2009 – All rights reserved vii
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SIST EN ISO 25424:2011
ISO 25424:2009(E)
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
re-sterilization in accordance with the manufacturer's instructions (see EN 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 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 European 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 European 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 European Standard does not specify the particular
individuals or organizations to carry out the activities.
Activities required by this standard might also give rise to an environmental burden that should be considered
and minimized, e.g. by utilizing flexibility in planning. Environmental aspects are addressed in Annex D of this
standard.
viii © ISO 2009 – All rights reserved
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SIST EN ISO 25424:2011
INTERNATIONAL STANDARD ISO 25424:2009(E)
Sterilization of medical devices — Low temperature steam and
formaldehyde — Requirements for development, validation and
routine control of a sterilization process for medical devices
...
SLOVENSKI STANDARD
kSIST FprEN ISO 25424:2011
01-februar-2011
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: FprEN ISO 25424
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
kSIST FprEN ISO 25424:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST FprEN ISO 25424:2011
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kSIST FprEN ISO 25424:2011
EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 25424
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 11.080.01
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 draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 204.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the 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.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 25424:2010: E
worldwide for CEN national Members.
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kSIST FprEN ISO 25424:2011
FprEN ISO 25424:2010 (E)
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
2
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kSIST FprEN ISO 25424:2011
FprEN ISO 25424:2010 (E)
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 FprEN
ISO 25424:2010 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of
which is held by BSI.
This document is currently submitted to the Unique Acceptance Procedure.
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, B and C, which are integral parts of this
document.
Endorsement notice
The text of ISO 25424:2009 has been approved by CEN as a FprEN ISO 25424:2010 without any
modification.
3
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kSIST FprEN ISO 25424:2011
FprEN ISO 25424:2010 (E)
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.
4
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kSIST FprEN ISO 25424:2011
FprEN ISO 25424:2010 (E)
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.
5
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kSIST FprEN ISO 25424:2011
FprEN ISO 25424:2010 (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
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.
6
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kSIST FprEN ISO 25424:2011
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
---------------------- Page: 9 ----------------------
kSIST FprEN ISO 25424:2011
ISO 25424:2009(E)
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Published in Switzerland
ii © ISO 2009 – All rights reserved
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kSIST FprEN ISO 25424:2011
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 2009 – All rights reserved iii
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kSIST FprEN ISO 25424:2011
ISO 25424:2009(E)
Contents Page
Foreword. vi
Introduction . vii
1 Scope .1
1.1 Inclusions .1
1.2 Exclusions .1
2 Normative references .2
3 Terms and definitions .2
4 Quality management system elements .8
4.1 Documentation.8
4.2 Management responsibility .8
4.3 Product realization.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 .9
5.4 Material effects.9
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.13
9.3 Operational qualification.14
9.4 Performance qualification.15
9.5 Review and approval of validation.16
10 Routine monitoring and control.17
10.1 General.17
10.2 Biological indicators .17
10.3 Chemical indicators.18
10.4 Records.18
11 Product release from sterilization.18
12 Maintaining process effectiveness .18
12.1 General.18
12.2 Maintenance of equipment .18
12.3 Requalification .19
12.4 Assessment of change.19
Annex A (normative) Process definition based on inactivation of reference microorganisms and
knowledge of bioburden on product items to be sterilized .20
Annex B (normative) Process definition based on inactivation of reference microorganisms.21
iv © ISO 2009 – All rights reserved
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kSIST FprEN ISO 25424:2011
ISO 25424:2009(E)
Annex C (informative) Guidance on application of this European Standard.23
Annex D (informative) Environmental aspects regarding development, validation and routine
control of Low Temperature Steam and Formaldehyde processes.33
Bibliography.37
© ISO 2009 – All rights reserved v
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kSIST FprEN ISO 25424:2011
ISO 25424:2009(E)
Foreword
This document (EN 15424:2007) has been prepared 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 October 2007, and conflicting national standards shall be withdrawn at
the latest by October 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 Directive(s).
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, 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.
vi © ISO 2009 – All rights reserved
---------------------- Page: 14 ----------------------
kSIST FprEN ISO 25424:2011
ISO 25424:2009(E)
Introduction
A sterile medical device is one which is free of viable microorganisms. European 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 EN 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 will enable the demonstration 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 EN 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.
© ISO 2009 – All rights reserved vii
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kSIST FprEN ISO 25424:2011
ISO 25424:2009(E)
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
re-sterilization in accordance with the manufacturer's instructions (see EN 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 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 European 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 European 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 European Standard does not specify the particular
individuals or organizations to carry out the activities.
Activities required by this standard might also give rise to an environmental burden that should be considered
and minimized, e.g. by utilizing flexibility in planning. Environmental aspects are addressed in Annex D of this
standard.
viii © ISO 2009 – All rights reserved
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kSIST FprEN ISO 25424:2011
INTERNATIONAL STANDARD ISO 25424:2009(E)
Sterilization of medical devices — 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 European 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 may be applicable to other products and equipment.
1.1.2 This European Standard is intended to be applied by process developers, manufacturers of
sterilization equipment, manufactur
...
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