ILT-U-2656
Packaging for terminally sterilized medical devices
V1:
DETERMINATION | METHOD |
| Visual Inspection | ASTM F1886 |
| Peeling and measuring the width of the sealing strip | EN 868-5 annex E |
| Seal leaks in porous medical packaging (dye penetration) | ASTM F1929 (Method A) |
| Seal strength test | EN 868-5 annex D |
V2:
| DETERMINATION | METHOD |
| Seal leaks in porous medical packaging (dye penetration) | ASTM F1929 |
| Seal strength test | EN 868-5 annexe D |
V3:
| DETERMINATION | METHOD |
| Visual Inspection | ASTM F1886 |
| Peeling and measuring the width of the sealing strip | EN 868-5 Annexe E |
V4:
DETERMINATION | METHOD |
| Visual Inspection | ASTM F1886 |
| Peeling and measuring the width of the sealing strip | EN 868-5 Annexe E |
| Seal leaks in porous medical packaging (dye penetration) | ASTM F1929 |
V5:
DETERMINATION | METHOD |
| Visual Inspection | ASTM F1886 |
| Seal leaks in porous medical packaging (dye penetration) | ASTM F1929 |
V6:
DETERMINATION | METHOD |
| Seal strength test | EN 868-5 annexe D |
| Visual Inspection | ASTM F1886 |
| Peeling and measuring the width of the sealing strip | EN 868-5 Annexe E |
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ILT-U-1376
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