<s>
IEC	B-Application
62304	I-Application
–	O
medical	O
device	O
software	O
–	O
software	O
life	O
cycle	O
processes	O
is	O
an	O
international	O
standard	O
published	O
by	O
the	O
International	O
Electrotechnical	O
Commission	O
(	O
IEC	O
)	O
.	O
</s>
<s>
The	O
standard	O
specifies	O
life	O
cycle	O
requirements	O
for	O
the	O
development	O
of	O
medical	B-Application
software	I-Application
and	O
software	O
within	O
medical	O
devices	O
.	O
</s>
<s>
The	O
IEC	B-Application
62304	I-Application
standard	O
calls	O
out	O
certain	O
cautions	O
on	O
using	O
software	O
,	O
particularly	O
SOUP	B-General_Concept
(	O
software	B-General_Concept
of	I-General_Concept
unknown	I-General_Concept
pedigree	I-General_Concept
or	O
provenance	O
)	O
.	O
</s>
<s>
The	O
standard	O
spells	O
out	O
a	O
risk-based	O
decision	O
model	O
on	O
when	O
the	O
use	O
of	O
SOUP	B-General_Concept
is	O
acceptable	O
,	O
and	O
defines	O
testing	O
requirements	O
for	O
SOUP	B-General_Concept
to	O
support	O
a	O
rationale	O
on	O
why	O
such	O
software	O
should	O
be	O
used	O
.	O
</s>
