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 (ISO 25424:2018/Amd 1:2022)

2022-01-13 - TC decision is missing to skip FV - publication on hold.

Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für Medizinprodukte - Änderung 1 (ISO 25424:2018/Amd 1:2022)

No scope available

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 (ISO 25424:2018/Amd 1:2022)

Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke - Dopolnilo A1 (ISO 25424:2018/Amd 1:2022)

General Information

Status
Published
Public Enquiry End Date
19-Jun-2021
Publication Date
15-Jun-2022
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
03-Jun-2022
Due Date
08-Aug-2022
Completion Date
16-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 25424:2020/A1:2022
01-julij-2022
Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s

formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih

postopkov za medicinske pripomočke - Dopolnilo A1 (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 (ISO 25424:2018/Amd 1:2022)

Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-

Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung

von Sterilisationsverfahren für Medizinprodukte - Änderung 1 (ISO 25424:2018/Amd
1:2022)

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 (ISO 25424:2018/Amd 1:2022)

Ta slovenski standard je istoveten z: EN ISO 25424:2019/A1:2022
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 25424:2020/A1:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 25424:2020/A1:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.080.01
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 - Amendment 1 (ISO 25424:2018/Amd
1:2022)

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

- Amendement 1 (ISO 25424:2018/Amd 1:2022) Sterilisationsverfahren für Medizinprodukte -

Änderung 1 (ISO 25424:2018/Amd 1:2022)

This amendment A1 modifies the European Standard EN ISO 25424:2019; it was approved by CEN on 28 December 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of

this amendment into the relevant 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 amendment 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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25424:2019/A1:2022 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this European Standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be

covered................................................................................................................................................................ 4

Annex ZB (informative) Relationship between this European Standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be

covered................................................................................................................................................................ 8

---------------------- Page: 4 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1:2022 (E)
European foreword

This document (EN ISO 25424:2019/A1:2022) 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 Amendment to the European Standard EN ISO 25424:2019 shall be given the status of a national

standard, either by publication of an identical text or by endorsement, at the latest by November 2022,

and conflicting national standards shall be withdrawn at the latest by November 2022.

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 has been prepared under a Standardization Request given to CEN by the European

Commission and the European Free Trade Association, and supports essential requirements of EU

Directive(s) / Regulation(s).

For the relationship with EU Regulation(s) see informative Annex ZA and ZB, which are integral parts of

this document.

Any feedback and questions on this document should be directed to the users’ national standards

body/national committee. A complete listing of these bodies can be found on the CEN website.

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 and ZB 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 in table ZA.2.

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/Amd 1:2022 has been approved by CEN as EN ISO 25424:2019/A1:2022

without any modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1:2022 (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

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.
---------------------- Page: 6 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1:2022 (E)

Table ZA.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
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
---------------------- Page: 7 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1:2022 (E)
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
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 is not
covered. Aspects of manufacture
other than those related to
attainment of sterility by low
temperature steam and
formaldehyde are not covered.
---------------------- Page: 8 ----------------------
SIST EN ISO 25424:2020/A1:2022
EN ISO 25424:2019/A1:2022 (E)

Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this

Annex ZA
Column 1 Reference Column 2 Column 3 Column 4
in Clause 2 International
Title Corresponding European
...

SLOVENSKI STANDARD
SIST EN ISO 25424:2020/oprA1:2021
01-junij-2021
Sterilizacija izdelkov za zdravstveno nego - Para z nizko temperaturo in s

formaldehidom - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih

postopkov za medicinske pripomočke - Dopolnilo A1 (ISO 25424:2018/DAM 1:2021)
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 (ISO 25424:2018/DAM 1:2021)

Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-

Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung

von Sterilisationsverfahren für Medizinprodukte - Änderung 1 (ISO 25424:2018/DAM
1:2021)

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 (ISO 25424:2018/DAM 1:2021)

Ta slovenski standard je istoveten z: EN ISO 25424:2019/prA1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 25424:2020/oprA1:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
DRAFT AMENDMENT
ISO 25424:2018/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-03-30 2021-06-22
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
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 25424:2018/DAM 1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
---------------------- Page: 3 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
ISO 25424:2018/DAM 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
ISO 25424:2018/DAM 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.

Amendment 1 to ISO 25424:2018 was prepared by Technical Committee ISO/TC 198, Sterilization of

health care products.

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.
© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
---------------------- Page: 6 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
ISO 25424:2018/DAM 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
Terms and definitions

Delete all cross-references within the definitions to other terms defined in ISO 25424.

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".

3.41

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);

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, last line from

C.9.3.4 to C.9.4.4:
© ISO 2021 – All rights reserved 1
---------------------- Page: 7 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
ISO 25424:2018/DAM 1:2021(E)
Product life-cycle
Distribution Use End of life
Production and
Environmental aspects (including
reproduction
(inputs and outputs) packaging)
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 © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 25424:2020/oprA1:2021
ISO 25424:2018/DAM 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

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
...

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