<s>
SOUP	B-General_Concept
stands	O
for	O
software	O
of	O
unknown	O
(	O
or	O
uncertain	O
)	O
pedigree	O
(	O
or	O
provenance	O
)	O
,	O
and	O
is	O
a	O
term	O
often	O
used	O
in	O
the	O
context	O
of	O
safety-critical	B-Application
and	O
safety-involved	B-Application
systems	I-Application
such	O
as	O
medical	B-Application
software	I-Application
.	O
</s>
<s>
SOUP	B-General_Concept
is	O
software	O
that	O
has	O
not	O
been	O
developed	O
with	O
a	O
known	O
software	O
development	O
process	O
or	O
methodology	O
,	O
or	O
which	O
has	O
unknown	O
or	O
no	O
safety-related	O
properties	O
.	O
</s>
<s>
Often	O
,	O
engineering	O
projects	O
are	O
faced	O
with	O
economic	O
or	O
other	O
pressure	O
to	O
embody	O
SOUP	B-General_Concept
into	O
their	O
high	B-Application
integrity	I-Application
systems	I-Application
.	O
</s>
<s>
The	O
problem	O
with	O
SOUP	B-General_Concept
is	O
that	O
it	O
cannot	O
be	O
relied	O
upon	O
to	O
perform	O
safety-related	O
functions	O
,	O
and	O
it	O
may	O
prevent	O
other	O
software	O
,	O
hardware	O
or	O
firmware	O
from	O
performing	O
their	O
safety-related	O
functions	O
.	O
</s>
<s>
The	O
SOUP	B-General_Concept
problem	O
is	O
therefore	O
one	O
of	O
insulating	O
the	O
safety-involved	B-Application
parts	O
of	O
a	O
system	O
from	O
the	O
SOUP	B-General_Concept
and	O
its	O
undesirable	O
effects	O
.	O
</s>
<s>
It	O
is	O
not	O
prohibited	O
to	O
use	O
SOUP	B-General_Concept
but	O
additional	O
controls	O
are	O
needed	O
and	O
the	O
risk	O
needs	O
to	O
be	O
taken	O
into	O
account	O
.	O
</s>
<s>
Specific	O
practices	O
to	O
take	O
when	O
using	O
SOUP	B-General_Concept
as	O
part	O
of	O
a	O
medical	O
device	O
may	O
include	O
review	O
of	O
the	O
vendor	O
's	O
software	O
development	O
process	O
,	O
use	O
of	O
static	O
program	O
analysis	O
by	O
the	O
vendor	O
,	O
design	O
artifacts	O
,	O
and	O
safety	O
guidance	O
.	O
</s>
