The Imaflexell™ A01 features a three-layer design. The inner layer is made of low-density polyethylene combined with an antistatic agent, providing a permanent antistatic property. The core layer is composed of Metallocene linear lowdensity polyethylene, oering excellent tensile strength, transparency and durability. The outer layer is made of linear low-density polyethylene, providing excellent flexibility and resistance to punctures and tears.
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 | 26 / 13 |
| Elongation at Break (MD/TD) | ASTM D882 | % | 472/1103 |
| Haze | ASTM D1003 | % | 23 |
| Transmittance | ASTM D1003 | % | 90.2 |
| Density | ASTM D792 | gm/cm³ | 0.9 |
| Water Vapour Transmission Rate (23° C, 100% RH) |
ASTM F1249 | g/m2/24h | 0.26 |
| Oxygen Permeability (23°C, 0%RH) |
ASTM D3985 | cm3/m2/day/bar | 0.002 |