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ISO 13408-7:2012

Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
31. 7. 2012.

Опште информације

90.93     28. 9. 2023.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski   ruski  

Kupovina

Objavljen

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Apstrakt

ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification 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.
ISO 13408-7:2012 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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 13408-7:2012
90.93 Odluka o potvrđivanju standarda
28. 9. 2023.

Nacionalna preuzimanja

SRPS EN ISO 13408-7:2016  
ISS

Aseptična obrada proizvoda za zaštitu zdravlja – Deo 7: Alternativni postupci za medicinska sredstva i kombinovane proizvode

60.60   Standard objavljen

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