Intrinsically safe SaMD design

GSPR 17.1 and 18.1 pose a notable challenge to the designer: “in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks”.
How do you design a device that complies with these two requirements? It will be one of the topics of next Friday's course. In particular, we encounter the challenges that requirement 17.1 poses: non-intrinsically safe architectures do not respond to the logic of requirement 17.1. In particular monolithic embedded firmware cannot guarantee to “eliminate or reduce as far as possible consequent risks”. Therefore, a series of measures are needed (for example segregated software items) to provide guarantees: how the segregation of software items is achieved. IEC 62304 tells us that one of the possibilities is to use separate hardware for software items, but this, you understand, is not always possible. Are there alternative methods? Can we do this in all programming languages? We will try to respond on Friday 10/11/23. PS: for those who would like to participate... the course is remote in Italian.

Italian

I GSPR  17.1 e 18.1 pongono una sfida notevole al progettista:  “in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks”.

Come si progetta un dispositivo conforme a questi due requisiti ?  Sarà uno degli argomenti del corso di venerid prossimo.  In particolare ci occuremo delle sfide che ci pone il requisito 17.1 :  le architetture non intrinsecamente sicure non rispondono alla logica del requisito 17.1 . IN partcilare firmware embedded monolitici non possono garantire  di “eliminate or reduce as far as possible consequent risks”. Quindi occorrono una serie di accorgimenti (ad esmpio software item segragati) per dare garanzie : come si realizza la segregazione dei software item. LA IEC 62304 ci risponde che uno delel possibilità è usare hardware distinti per I software item , ma questo, capite bene, non èsempre possible. Ci sono metodi alternative ? Lo possimao fare in tutti i linguaggi di programmazione ?  Cercheremo di respondere Venerdì 10711/23. PS: per chi volesse participare il corso è da remote in lingua italiana.