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 avant la stérilisation, telles que les opér

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

Status
Published
Public Enquiry End Date
24-Mar-2017
Publication Date
12-Jan-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Dec-2019
Due Date
15-Feb-2020
Completion Date
13-Jan-2020

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 25424:2020
---------------------- Page: 2 ----------------------
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.

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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
---------------------- Page: 13 ----------------------
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
---------------------- Page: 14 ----------------------
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.
---------------------- Page: 15 ----------------------
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
---------------------- Page: 16 ----------------------
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
...

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