For the Hard Part
Sensory Analysis:
Parameter: Food Simulant: Median Grade: Limit Value*
Odour Water 1.5
(Just recognizable to slight deviation, chemical)
2.5
Taste Water 2.5
(Slight to intense deviation, chemical and
flavoured)
2.5
* From 61. Statement of BfR, Bundesgesundheitsbl. 46, 2003, 362-5.
Analysis - BfR recommendation XV on silicone:
Parameter:
Result: Limit value **
Extractable components in water < 0.2 % 0.5 %
Extractable components in 3% acetic acid < 0.3 % 0.5 %
Extractable components in 10% ethanol < 0.2 % 0.5 %
Volatile Compounds < 0.1 % 0.5 %
Platinum 5 mg/kg 50 mg/kg
** According to BfR recommendation XV on silicone
Extraction Analysis:
Parameter:
Single determinations [mg/
inch²]
Limit Value [mg/
inch²]
Water-extracted residue after 7 hours 0.19 < 20
Water-extracted residue after +2
hours
< 0.1 < 1
For the Soft Part
Parameter:
Food Simulant: Median Grade: Limit Value*
Odour Water 1
(Just recognizable to slight deviation, chemical)
2.5
Taste Water 1
(Slight to intense deviation, chemical and
flavoured)
2.5
* From 61. Statement of BfR, Bundesgesundheitsbl. 46, 2003, 362-5.
Analysis - BfR recommendation XV on silicone:
CERTIFICATIONS
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