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EN ISO 25424:2019/A1:2022

(Amendment)

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)

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
Publication Date
24-May-2022
Withdrawal Date
29-Nov-2022
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
CEN/TC 204 - Sterilization of medical devices
Drafting Committee
CEN/TC 204 - Sterilization of medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
25-May-2022
Completion Date
25-May-2022
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN ISO 25424:2020/A1:2022 - 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)

Relations

Amends
EN ISO 25424:2019 - 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)
Effective Date
10-Jun-2020

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EN ISO 25424:2020/A1:2022EN ISO 25424:2020/A1:2022
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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

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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.

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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

2

---------------------- Page: 4 ----------------------
SIST EN
...

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1.1    Inclusions
1.1.1    This document 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.
NOTE       Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.
1.1.2    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).
1.2    Exclusions
1.2.1    This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE       See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
1.2.2    This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1.
1.2.3    This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE       It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4    This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1    Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
NOTE 2    Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5    This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.
NOTE 1    Attention is drawn to EN 14180.
NOTE 2    Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6    This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
NOTE       For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).

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