BS EN ISO 25424:2011 - Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
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BS EN ISO 25424:2011

Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

Status : Superseded, Withdrawn   Published : August 2011 Replaced By : BS EN ISO 25424:2019

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ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. ISO 25424:2009 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. ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.




Standard NumberBS EN ISO 25424:2011
TitleSterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
StatusSuperseded, Withdrawn
Publication Date31 August 2011
Withdrawn Date21 November 2019
Normative References(Required to achieve compliance to this standard)EN 14180:2003, ISO 11737-2:1998, EN ISO 13485, ISO 11737-1:2006, EN ISO 11138-5:2006, EN ISO 11140, ISO 11138-1:2006, ISO 11138-5:2006, EN ISO 11737-2, EN ISO 11737-1, ISO 13485:2003, EN ISO 11138-1
Informative References(Provided for Information)97/23/EC, 93/42/EEC, EN ISO 14937:2000, EN ISO 10993-17, EN ISO 11607, EN 867-5, IEC 61010-2-040:2005, EN 61010-2-040, ISO 10993-1:2003, EN 556-1, 80/778/EEC, ISO 14937:2000, 98/79/EC, 90/385/EEC, EN ISO 9000:2005, ISO 10993-17:2002, ISO 14161:2000, EN ISO 17664, ISO/TS 11139:2006, ISO 10012:2003, ISO 17664:2004, EN ISO 15883, EN ISO 14161, EN ISO 10993-1, ANSI/AAMI RD 47:1993, EN ISO 10012, EN 868
Replaced ByBS EN ISO 25424:2019
ReplacesBS EN 15424:2007
International RelationshipsISO 25424:2011,ISO 25424:2009,EN ISO 25424:2011
DescriptorsPerformance testing, Formaldehyde, Steam sterilizers, Qualification approval, Packaging, Sterilization (hygiene), Verification, Medical equipment, Environmental engineering, Sterilizers, Microbiological analysis, Quality control, Low temperatures, Specification (approval)
ICS11.080.01
Title in FrenchStérilisation des dispositifs médicaux. Formaldéhyde et vapeur à faible temperature. Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
Title in GermanSterilisation von Medizinprodukten. Niedertemperatur- Dampf- Formaldehyd. Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für Medizinprodukte
CommitteeCH/198
ISBN978 0 580 72806 8
PublisherBSI
FormatA4
DeliveryYes
Pages54
File Size1.151 MB
Price£254.00


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