The Imaflexell™ L01 features a three-layer design with an inner contact layer of Ultra Low-Density Polyethylene (ULDPE), enhancing mechanical strength, flexibility and toughness. The outer layer is made of Low-Density Polyethylene (LDPE), providing resistance to abrasions, punctures and tears, eectively preventing leaks. The core layer, made of Linear Low-Density Polyethylene (LLDPE) for flexibility with enhanced toughness, improving puncture resistance
Ami Polymer Pvt. Ltd. certifies that the product mentioned in this catalogue complies as per below listed testing requirments. Described here in;
| Biological Reactivity, in vitro (Cytotoxicity Test) | USP<87> |
| Biological Reactivity, in vivo (Acute Systemic Toxicity, Intracutaneous and Implantation Test) | USP <88> |
| Bacterial Endotoxins - LAL Test | USP<85> |
| Extractable Study as per BPOG Guidelines | 24 hours, 21 days, *70 days |
| Physicochemical Test | USP <661.1> |
| Hemocompatibility Test | ISO 10993-4 |
| Skin Sensitization Test | *ISO 10993-10 |
| Skin Irritation Test | ISO 10993-23 |
| Food grade test | FDA 21 CFR 177. 1520 |
| ROHS Complied (Restriction of hazardous substance) | Directive (EU) 2015/863 |
| REACH (SVHC) Complied | (EC) No 1907/2006 |
| TSE/BSE Declaration (ADI -Animal Derived Ingredients free) | |
| Phthalate Content Free | |
| Bisphenol A (BPA) Content Free | |
| Technical Data | Test Method | Unit of Measure | Values |
|---|---|---|---|
| Tensile Strength at Break | ASTM D882 | MPa | 23 / 19 |
| Elongation at Break (MD/TD) | ASTM D882 | % | 732/1189 |
| Haze | ASTM D1003 | % | 5.9 |
| Transmittance | ASTM D1003 | % | 85.5 |
| Density | ASTM D792 | gm/cm³ | 0.89 |