Regulatory documentation
Material Safety
The Silent Knight is a mechanical device that contains no chemical substances, gases, or hazardous preparations. Under CLP Regulation (EC) 1272/2008 the device is not classified as hazardous, so no chemical safety documentation is required; however, we publish full material composition and safety information for facility risk assessments.
Classified as non-hazardous
No flammable, toxic, corrosive, or sensitising substances are present. The device and pouches are inert under normal storage and use conditions.
Material composition
| Component | Material | Notes |
|---|---|---|
| Crusher housing & base | ABS / polypropylene | Non-rusting, food-contact safe |
| Crushing plates & handle | Stainless steel / reinforced polymer | Corrosion resistant |
| Genuine pouches (PC800 / PC1000) | Multi-layer LDPE film | Latex-free, single-use |
| Adhesives & inks | Water-based, food-grade | No SVHC above threshold |
Regulatory compliance
- Latex-free across all components
- RoHS 2011/65/EU compliant
- REACH (EC) 1907/2006 — no SVHC above 0.1% w/w
- Food-contact materials per EU 10/2011
Handling & disposal
Wipe clean with a damp cloth or facility-approved disinfectant. Used pouches that have contained crushed medication should be treated as pharmaceutical waste and disposed of per local facility policy. The device itself is recyclable as mixed plastics at end-of-life.
Note: when crushing hazardous or cytotoxic drugs, observe USP <800> and the safety information of the specific medication being prepared — the medication, not the device, determines exposure controls.
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