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)

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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)

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)

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Status
Not Published
Current Stage
4060 - Closure of enquiry - Enquiry
Due Date
22-Jun-2021
Completion Date
22-Jun-2021

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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.

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SIST EN ISO 25424:2020/oprA1:2021
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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
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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
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SIST EN ISO 25424:2020/oprA1:2021
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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
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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
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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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