Quality & Compliance
Certificates are paper; test data is proof. Here is exactly what we test and what we guarantee.
Material & Product Compliance
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FDA 21 CFR 177.2600
US food-contact silicone rubber
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LFGB / BfR XV
German food-contact, incl. sensory testing
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EU 1935/2004
EU food-contact framework compliance
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ISO 10993 / USP Class VI
Biocompatibility for medical materials
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ROHS / REACH
Environmental compliance for electronics
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EN 1400
Baby soothers & pacifiers (EU)
What We Test
| Volatile matter (200°C) | Every compound lot — target < 0.3% for baby/medical grades |
| Compression set | ISO 815, 22h/150°C — design validation & ongoing QA |
| Peel strength (overmolds) | 100 thermal cycles -40°C to +150°C before approval |
| Migration testing | Food simulants per EU 10/2011 methodology |
| Dimensional inspection | 100% on critical dimensions; CMM reports on request |
Need a specific standard?
If your market requires a standard not listed above, send it with your inquiry — we routinely validate against customer-specific protocols.
Need custom silicone parts?
From prototype samples to volume production — send us your drawing or sample for a quote within 24 hours.