2
Contents
A. General Description of the PSD Film and Articles .................................................................................... 4
B. Properties of the PSD Film ........................................................................................................................ 4
B1. Mechanical Testing ................................................................................................................................. 4
B1.1. Gelbo Flex ..................................................................................................................................... 4
B1.2. Thickness ...................................................................................................................................... 4
B1.3. Strength and Elongation ................................................................................................................ 4
B1.4. Puncture Resistance ..................................................................................................................... 4
B1.5. Dart Impact ................................................................................................................................... 5
B1.6. Tear Resistance ............................................................................................................................ 5
B2. Physical Testing ...................................................................................................................................... 5
B2.1. Surface Resistivity ......................................................................................................................... 5
B3. Chemical and Biological Testing ............................................................................................................. 5
B3.1. Biological Reactivity – In Vitro – ISO 10993-5 and USP <87> Elution Test .................................... 5
B3.2. Biological Reactivity – In Vivo – USP <88> Class VI Plastics ......................................................... 5
B4. Physicochemical Tests .......................................................................................................................... 6
B4.1. Tests on Plastic Materials and Components Used to Package Medical Articles USP <661> ........ 6
B5. Functional Testing on Powder Handling Bag .......................................................................................... 6
B5.1. Functional Weight Test .................................................................................................................. 6
B5.2. Powder Transfer Efciency ............................................................................................................ 6
B5.3. Functional Drop Test ..................................................................................................................... 6
B6. Overview Testing Results ........................................................................................................................ 6
B6.1. Mechanical Results ....................................................................................................................... 6
B6.1.1. Gelbo Test ........................................................................................................................ 7
B6.1.2. Thickness .......................................................................................................................... 7
B6.1.3. Strength and Elongation .................................................................................................... 7
B6.1.4. Puncture Resistance ........................................................................................................ 7
B6.1.5. Dart Impact ....................................................................................................................... 7
B6.1.6. Tear Resistance ................................................................................................................ 8
B6.2. Physical Testing ............................................................................................................................ 8
B6.2.1. Surface Resistivity ............................................................................................................. 8
B6.3. Chemical and Biological Testing .................................................................................................... 8
B6.3.1. Biological Reactivity – In Vitro – ISO 10993-5 and USP <87> Elution Test ....................... 8
B6.3.2. Biological Reactivity – In Vivo – USP <88> Class VI Plastics Test .................................... 8
B6.4. Physicochemical Test Results ....................................................................................................... 8
B6.4.1. Tests on Plastic Materials and Components Used to Package Medical Articles
USP <661> ...................................................................................................................... 8