| 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 |
| Material | Test Item | Test standard |
|---|---|---|
| SBS,TPR,TPE,rubber，silicon |
water extractives n-hexane extractives |
21CFR 177.2600 Rubber articles intended for repeated use |
| Material | Test Item | Regulation/ standard | Test Method |
|---|---|---|---|
| Rubber | Overall migration |
French Décret nº 2007-766 DGCCRF No.2004/64 |
EN 1186 1-14:2002 |
| Volatile organic matter（VOM） | Order of 25/11/1992，annex III, section 2 | ||
| Nitrosamine and nitrosatable substances | EN 12868:1999 | ||
| Specific migration of aromatic amine | EN 13130-1:2004 | ||
| Extractable formaldehyde | |||
| Peroxide Value | French pharmacopoeia Xth edition | ||
| Silicon | Overall migration |
French Décret nº 2007-766 DGCCRF No.2004/64 |
EN 1186-1~14 |
| Peroxide Value | French pharmacopoeia Xth edition | ||
| Volatile organic matter（VOM） | Order of 25/11/1992，annex III, section 2 | ||
| Organotin | ISO 17353:2004 |
| 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 | ||
| Volatile organic matter（VOM） |
LFBG BfR Part Ⅱ section XV, May 2003 and LFBG section 35 B80.30 1(EG). |
||
| Organotin | ISO 17353:2004 |
| 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 |
| rubber 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 |
