BusinessBUSINESS
EU
Material | Test Item | Regulation/ standard | Test Method |
Rubber | Overall migration Specific migration of aromatic amines |
AP (2004)4 Rubber | EN 1186 1-14:2002 |
Nitrosamine and nitrosatable substances | EN 12868:1999 | ||
Silicon | Overall migration (water、3% acetic acid、10% ethanol、substitute of rectified olive oil) | AP(2004)5 Silicone Rubber | EN 1186 1-14:2002 |
USA
Material | Test Item | Regulation/ standard |
SBS,TPR,TPE,rubber,silicon | water extractives n-hexane extractives |
21CFR 177.2600 Rubber articles intended for repeated use |
Germany
Material | Test Item | Regulation/ standard | Test Method |
Rubber, TPR, TPE |
Sensory test | LFGB 30&31 | DIN 10955:2004 |
Overall migration Specific migration of aromatic amine |
EN 1186 1-14:2002 | ||
Nitrosamine and nitrosatable substances | EN 12868:1999 | ||
Organotin | ISO 17353:2004 | ||
Extractable formaldehyde | EN 1541:2001 | ||
Total zinc and lead content | EPA 3052:1996 | ||
Silicon | Sensory test | LFGB 30&31 | DIN 10955:2004 |
Overall migration | EN 1186 1-14:2002 | ||
Peroxide Value | European Pharmacopeia 1997, p.173 |
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Volatile organic matter(VOM) | LFGB BfR Part Ⅱ Section XV, May 2003 and LMGB section 35 B80.30 1(EG) |
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Organotin | ISO 17353:2004 |
China
Material | Test Item | Regulation/ standard | Test Method |
Rubber products | Sensory test (appearance+ Soaking solution) Evaporation residue(Water, 4% Acetic Acid, 65% Ethanol, N-hexane) Consumption of potassium permanganate Heavy metal as lead Zn(elution) Residual acrylonitrile (only for rubber containing Acrylonitrile) |
GB 4806.1-1994 Hygienic standard for foodstuff rubber products |
GB/T 5009.60-2003 GB/T 5009.64-2003 |
Rbber nipple | Sensory test (appearance+ Soaking solution) Evaporation residue(Water, 4% Acetic Acid, 65% Ethanol, N-hexane) Consumption of potassium permanganate Heavy metal as lead Zn(elution); |
GB 4806.2-1994 Hygienic standard for rubber nipple |
GB/T 5009.60-2003 GB/T 5009.64-2003 |