Samson 3349 - Page 86

14-12 EB 8048-2 EN
SAMSON REGULATION S.A.S. · 1, rue Jean Corona · 69120 Vaulx-en-Velin, France · samson@samsongroup.com 4
Detailed conditions and results of migration test on PTFE membrane
Overall migration (OM)
The maximum limit on the overall migration (OML) has been tested and measured in accordance with the following
table:
Simulant Duration Temperature
Ratio surface /
volume (dm
2
/dl)
OML
(mg/dm
2
)
Results
(mg/dm
2
)
10% ethanol 2 h Back flow temperature 1 10 1.9
4% acetic acid 2 h Back flow temperature 1 10 1.8
Vegetal oil 2 h Back flow temperature 1 10 0.2
Specific migration (SM)
The maximum limits on the specific migration (SML) of substances authorized by the Regulation GB 4806.6
5
and GB
4806.9
5
have been tested and measured in accordance with the following tables:
Polymer name No CAS No
SML
(mg/kg)
Status
PTFE= Polytetrafluoro- Ethylène
87
9002-84-0
0.05
OK
Simulant Duration Temperature Item
Results
(mg/kg)
SML
(mg/kg)
Status
4% acetic
acid
2h
Back flow
temperature
As
<0.01
< 0.04
OK
Cd
<0.002
< 0.02
OK
Cr
0.01
< 2.0
OK
Ni
0.02
< 0.5
OK
Pb
0.01
< 0.05
OK
Detailed conditions and results of migration test on metallic parts in steel 1.4435 / 316 L
Overall migration (OM)
The maximum limit on the overall migration (OML) has been tested and measured in accordance with the following
table:
Simulant Duration Temperature
Ratio Surface /
volume (dm
2
/dl)
OML
(mg/dm
2
)
Results
(mg/dm
2
)
10% ethanol
2h
Back flow temperature
1
10
1.0
4% acetic acid
2h
Back flow temperature
1
10
1.2
95% ethanol
3.5h
*60°
1
10
0.5
Isooctane
1.5h
*60°
1
10
0.4
*The OL 95% and ISO test conditions correspond to conventional fatty medium substitution test conditions (2 h at 100°C). These
conditions are quoted in the European standard ISO 1186-1 (2002)
Specific migration (SM)
The maximum limit on the specific migration (SML) of substances authorized by the Regulation GB 4806.9
5
has been
tested and measured in accordance with the following table:
Simulant Duration Temperature Item
Results
(mg/kg)
SML
(mg/kg)
Status
4% acetic acid 2h
Back flow
temperature
As
<0.01
< 0.04
OK
Cd
<0.002
< 0.02
OK
Cr
0.01
< 2.0
OK
Ni
0.02
< 0.5
OK
Pb
0.01
< 0.05
OK
SAMSON REGULATION S.A.S.
SAMSON REGULATION S.A.S.
Bruno
Soulas
Head of
Strategy and Development
Joséphine Signoles
-Fontaine
Head of QSE Department