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SSH EN ISO 13408-7:2015

Trajtimi antimikrobik ndaj produkteve të kujdesit shëndetësor - Pjesa 7: Proceset alternative për pajisjet mjekësore dhe produktet e kombinuara (ISO 13408-7:2012)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
29 mar 2016

General information

60.60     29 mar 2016

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

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Scope

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.

Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara
90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara

Life cycle

NOW

PUBLISHED
SSH EN ISO 13408-7:2015
60.60 Standard published
29 mar 2016

Related project

Adopted from EN ISO 13408-7:2015