►
7i
h,ov-...., Jo c. ell p-roc.e£ses Oc.c..v-r 'u ~ o vv c on.. ""'e co n.-\-ro\ -,-h ero .
-1...,nde,st-ar-d i ng ~act-ors ;,,-y-,pon::on t-- v, -tne cle:-<;;;i9 f""\ t, s elec1:_., b n of-
0 1 orro-\-ef,af;'
J OCOJ q re-a J
s-t-rvc-h.,'"" e - pr-Ope,-l-y -1:'fpe s o-\-- 'o '() 'l"l")o+e.r, 0 1,;;
• bi oc.ornpo-t-'i b , L·, \- y · b1orr101-er10.l sete ct i<:::>r-.
def, nifions
1. A non.,-viab/e mo-teria/ usecl in a rnec/ica/ device no+ 1riter,ded 4' -to
1n+-er-ac-t vv/ bi0\0:3 1 ca1 Systems
2 . A
~ ·t::'hcse d~,n, CIO\f.:; f-QCVS Q("\ lce\rq ·,"<Je,-t,but not-nir-,g ·,'2, +r-v\'7' \ner--\:;
<T10~1<Il +rat- inter--oc\--'S "YV 1\:-h
0
3. a. viold.e O'r <lO'n viab\e t--'ne biol~ical
envi ""o-nn,e<"\b l, 1-\:S -h..... nc.\- "1e>n \5 -1::o dioq0ose , tree+ / Support; ovgme0t O '<
r-eo\a.ce po,t. o, all of o Liv·,:13 S'/S-1-em _
c Dn.icat needs for b;orriatcnal.s
biolcq·,ca1 qraf---\-£
➔ OLrt-oq,afi- - from 'y'ou,,...self-
~ otLoq,of+ - f,ort) sorneore eise cte-rnond
➔ X'enog ,a-f--\--s - from on\trrne< spe.c\es;;
~ con<o1de..- p,OS O CO\""")S cl e:;ach 9'°---r-T
· c.o",,i,dev- bi o~v nc~\onoLH::y CZJ biocornP=t-tibi li+y
~ ·,0-f lOl'fln'at10° ➔ a\le-rg,c:.. reGPart3e
4 wovnd heolirg -, \ rifect'lon
• nOSt Y-eGp:)~ m o \-et", 0 \ res~ r, 9=
_,_ 1n.i 'clo I events: -K:.Or1... 0'S-t6Y"\
➔ i "f\.f- \om fY""I a \-I en -, fa-t,gue
-'> irnmvno\cx3'1cal . ..:i, +rCl C t"U\"e'
➔ en'Z.y mat ·,c ➔ deg ,oda-hOt"\
I/
-bocte,no.L "infecbo0 _., od~Or-ption Locs o~ t.',a \
_., neopto<;:·o. and e-r-ror ' 1
7i
h,ov-...., Jo c. ell p-roc.e£ses Oc.c..v-r 'u ~ o vv c on.. ""'e co n.-\-ro\ -,-h ero .
-1...,nde,st-ar-d i ng ~act-ors ;,,-y-,pon::on t-- v, -tne cle:-<;;;i9 f""\ t, s elec1:_., b n of-
0 1 orro-\-ef,af;'
J OCOJ q re-a J
s-t-rvc-h.,'"" e - pr-Ope,-l-y -1:'fpe s o-\-- 'o '() 'l"l")o+e.r, 0 1,;;
• bi oc.ornpo-t-'i b , L·, \- y · b1orr101-er10.l sete ct i<:::>r-.
def, nifions
1. A non.,-viab/e mo-teria/ usecl in a rnec/ica/ device no+ 1riter,ded 4' -to
1n+-er-ac-t vv/ bi0\0:3 1 ca1 Systems
2 . A
~ ·t::'hcse d~,n, CIO\f.:; f-QCVS Q("\ lce\rq ·,"<Je,-t,but not-nir-,g ·,'2, +r-v\'7' \ner--\:;
<T10~1<Il +rat- inter--oc\--'S "YV 1\:-h
0
3. a. viold.e O'r <lO'n viab\e t--'ne biol~ical
envi ""o-nn,e<"\b l, 1-\:S -h..... nc.\- "1e>n \5 -1::o dioq0ose , tree+ / Support; ovgme0t O '<
r-eo\a.ce po,t. o, all of o Liv·,:13 S'/S-1-em _
c Dn.icat needs for b;orriatcnal.s
biolcq·,ca1 qraf---\-£
➔ OLrt-oq,afi- - from 'y'ou,,...self-
~ otLoq,of+ - f,ort) sorneore eise cte-rnond
➔ X'enog ,a-f--\--s - from on\trrne< spe.c\es;;
~ con<o1de..- p,OS O CO\""")S cl e:;ach 9'°---r-T
· c.o",,i,dev- bi o~v nc~\onoLH::y CZJ biocornP=t-tibi li+y
~ ·,0-f lOl'fln'at10° ➔ a\le-rg,c:.. reGPart3e
4 wovnd heolirg -, \ rifect'lon
• nOSt Y-eGp:)~ m o \-et", 0 \ res~ r, 9=
_,_ 1n.i 'clo I events: -K:.Or1... 0'S-t6Y"\
➔ i "f\.f- \om fY""I a \-I en -, fa-t,gue
-'> irnmvno\cx3'1cal . ..:i, +rCl C t"U\"e'
➔ en'Z.y mat ·,c ➔ deg ,oda-hOt"\
I/
-bocte,no.L "infecbo0 _., od~Or-ption Locs o~ t.',a \
_., neopto<;:·o. and e-r-ror ' 1
