Samson 3349 Mounting And Operating Instructions page 80

Aseptic angle valve with usp-vi diaphragm, valve with pneumatic actuator and positioner, valve combined with pneumatic piston actuator and positioner
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Detailed conditions and results of migration tests on the diaphragm in PTFE
Overall migration (OM)
The maximum limit on the overall migration (OML) has been tested and measured in accordance with the following
table:
Test
conditions
MG 5
MG 5
MG 5
Specific migration (SM)
The maximum limits on the specific migration (SML) of substances authorised in the annexes I and II of the Regula-
tion (EU) No. 10/2011
Metal
Al
As
Ba
Cd
Co
Cr
Cu
Eu
Fe
Ga
SAMSON REGULATION S.A.S.
Bruno Soulas
Head of Strategy and Development
SAMSON REGULATION S.A.S. · 1, rue Jean Corona · 69120 Vaulx-en-Velin, France · samson@samsongroup.com
14-6
Simulant
Duration
A : 10% ethanol
2 h
B : 3% acetic acid
2 h
D2 : Oil
2 h
5
as amended have been tested and measured in accordance with the following tables:
Monomer
TFE = tetrafluorethylene
PPVE = Perfluoropropylvinyl Ether
Result
SML
(mg/kg)
(mg/kg)
1
<0.1
0.01
<0.01
1
<0.5
0.002
<0.002
0.05
<0.02
0.01
<0.01
5
<2
0.05
<0.05
48
<10
0.05
<0.05
Ratio surface /
Temperature
volume (dm
2
/dl)
100°C
1
100°C
1
100°C
1
FCM No
CAS No
SML (mg/kg)
281
116-14-3
423
1623-05-8
SML
Status
Metal
(mg/kg)
OK
Hg
0.01
OK
La
0.05
OK
Li
0.6
OK
Mn
0.6
OK
Ni
0.02
OK
Pb
0.01
OK
Sb
0.04
OK
Tb
0.05
OK
Zn
OK
SAMSON REGULATION S.A.S.
Joséphine Signoles-Fontaine
Head of QSE Department
OML
Result
(mg/dm
2
)
(mg/dm
10
1.2
10
1.0
10
0.2
Status
0.05
OK
0.05
OK
Result
Status
(mg/kg)
<0.01
OK
<0.05
Ok
<0.2
OK
<0.2
Ok
<0.02
OK
<0.01
OK
<0.04
OK
<0.05
OK
5
<1
OK
EB 8048-2 EN
2
)
4

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