Standard Svensk standard · SS-ISO 13408-7:2012

Aseptisk behandling av medicintekniska produkter - Del 7: Alternativa processer för atypiska medicintekniska produkter och kombinerade produkter (ISO 13408-7:2012, IDT)

Status: Gällande

This part of ISO 13408 specifes requirements and provides guidance on alternative approaches to process simulations for the qualifcation of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.

This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.


Sterilisering och desinficering allmänt (11.080.01) Desinficeringsmedel och antiseptika (11.080.20) Övrigt (11.080.99)


Språk: Engelska

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

Internationell titel: Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products (ISO 13408-7:2012, IDT)

Artikelnummer: STD-88280

Utgåva: 1

Fastställd: 2012-12-06

Antal sidor: 32