SIST EN ISO 25424:2020/oprA1:2021

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

Requirements for development, validation and routine control of a sterilization process

Sterilisation von Produkten für die Gesundheitsfürsorge - Niedertemperatur-Dampf-

Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung

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)

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

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

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

Any feedback or questions on this document should be directed to the user’s national standards body. A

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

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

"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".

Replace term and definition with the correct definition from ISO 11139:2018, 3.137 as follows:

graphical representation of decrease in viability of a population of microorganisms with increasing

b) if chemical indicators are used as part of the product release, the complete colour change

c) if biological indicators or PCDs containing BIs are used as part of the product release,

Replace wrong cross-reference in line "3 emission to air"/column "used, Stage C, last line from

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

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

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk