Standard Svensk standard · SS-EN ISO 25424:2011

Sterilisering av medicintekniska produkter - Lågtemperatur ång- och formaldehyd sterilisatorer - Krav för utveckling, validering och rutinkontroll av en steriliseringsprocess för medicintekniska produkter (ISO 25424:2009)

Status: Gällande

Omfattning
1.1 Inclusions

1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.

NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

1.1.2 This European Standard 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 EN ISO 14937:2000, Table E.1) 1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.

Ämnesområden

Sterilisering och desinficering allmänt


Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

Internationell titel: Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

Artikelnummer: STD-80705

Utgåva: 1

Fastställd: 2011-06-23

Antal sidor: 58

Ersätter: SS-EN 15424:2007