ISO 25424:2018/Amd 1:2022

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1

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 — Amendement 1

General Information

• Status: Published
• Publication Date: 11-Jan-2022
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198 - Sterilization of health care products
• Current Stage: 6060 - International Standard published
• Start Date: 12-Jan-2022
• Due Date: 02-Dec-2021
• Completion Date: 12-Jan-2022

Relations

• Consolidates: ISO 7526:2020 - Ferronickels — Determination of sulfur content — Infrared absorption method after induction furnace combustion
• Effective Date: 06-Jun-2022
• Amends: 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
• Effective Date: 14-Aug-2021

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 25424
Second edition
2018-10
AMENDMENT 1
2022-01
Sterilization of health care products —
Low temperature steam and
formaldehyde — Requirements for
development, validation and routine
control of a sterilization process for
medical devices
AMENDMENT 1
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
AMENDEMENT 1
Reference number
ISO 25424:2018/Amd.1:2022(E)
© ISO 2022

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ISO 25424:2018/Amd.1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
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  © ISO 2022 – All rights reserved

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ISO 25424:2018/Amd.1:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
Th
...

NORME ISO
INTERNATIONALE 25424
Deuxième édition
2018-10
AMENDMENT 1
2022-01
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
AMENDEMENT 1
Sterilization of health care products — Low temperature steam and
formaldehyde — Requirements for development, validation and
routine control of a sterilization process for medical devices
AMENDMENT 1
Numéro de référence
ISO 25424:2018/Amd.1:2022(F)
© ISO 2022

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ISO 25424:2018/Amd.1:2022(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse
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ISO 25424:2018/Amd.1:2022(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de
brevets reçues par l'ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion
de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www.iso.org/avant-propo
...

INTERNATIONAL ISO
STANDARD 25424
Second edition
2018-10
AMENDMENT 1
2021-12
Sterilization of health care products —
Low temperature steam and
formaldehyde — Requirements for
development, validation and routine
control of a sterilization process for
medical devices
AMENDMENT 1
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
AMENDEMENT 1
PROOF/ÉPREUVE
Reference number
ISO 25424:2018/Amd.1:2021(E)
© ISO 2021

---------------------- Page: 1 ----------------------
ISO 25424:2018/Amd.1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
PROOF/ÉPREUVE © ISO 2021 – All rights reserved

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ISO 25424:2018/Amd.1:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iii
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ISO 25424:2018/Amd.1:2021(E)
Sterilization of health care products — Low temperature
steam and formaldehyde — Requirements for
development, validation and routine control of a
sterilization process for medical devices
AMENDMENT 1

Page 2, Clause 3 Terms and definitions
Delete all cross-references within the definitions to other terms defined in Clause 3.

3.18
Replace the sentence after the list ("and does not achieve its primary intended action by
pharmacological, immunological or metabolic means, but which may be assisted in its intended
function by such means") with the following:
"and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means".

3.18
Correct SOURCE statement
from:
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been
added.]
to:
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been
added and the paragraph after the first list has been modified to include "in or on the human body".]
3.41
Replace term and definition with the correct definition from ISO 11139:2018, 3.137 as follows:
3.41
inactivation curve
graphical representation of decrease in viability of a population of microorganisms with increasing
exposure to a microbicidal agent under stated conditions
11.1 b) and c)
Replace 11.1 b) and c) with the following text:
b) if chemical indicators are used as part of the product release, the complete colour change of these
(see 8.4 and 10.3);
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ISO 25424:2018/Amd.1:2021(E)
c) if biological indicators or PCDs containing BIs are used as part of the product release, acceptable
results after cultivation of these (see 8.3 and 10.2); and

Table D.1
Replace wrong cross-reference in line "3 emission to air"/column "used, Stage C, second to last line
from C.9.3.4 to C.9.4.4.
Product life-cycle
Distribution
Production and
(including pack- Use End of life
Environmental aspects
reproduction
aging)
(inputs and outputs)
Stage A Stage B Stage C Stage D
Addressed Addressed Addressed Addressed

in clause in clause in clause in clause
3 Emission to air Introduction Introduction
5.1 5.1
5.5 5.5
6.3.3 6.3.3
8.6 8.6
— —
9.3.1 9.3.1
9.3.3 9.3.3
9.4.2.2 9.4.2.2
C.9.3.4 C.9.3.4
C.9.4.4 C.9.4.4
2
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ISO 25424:2018/Amd.1:2021(E)
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ISO 25424:2018/Amd.1:2021(E)
Annex ZA
(informative)
Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU)
2017/745 aimed to be covered
NOTE Annex ZA is not included in the final ISO publication.
This European standard has been prepared under a Commission’s standardisation request M/575 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] and to system or
process requirements including those relating to quality management systems, risk management, post-
market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-
up.
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 ZA.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.
Where a definition in this standard differs from a definition of the same term set out in Regulation
(EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard
in support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail. In this context, the definition of ‘medical device’ in EN ISO 25424 is a modified
version of the definition prepared by the Global Harmonization Task Force with modification to the
Note in the definition.
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 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 a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
4
PROOF
...