Packaging for medical devices
A key issue for most medical devices is sterility or purity of the product and the product's packaging to ensure that sterility is maintained throughout its shelf life. Selection of packaging is also very important for the ultimate purity and the surface of e.g. implants. At SP, we have the ability to combine transportation and environmental durability tests with product tests.
SP offers the following tests:
- Test of the package’s mechanical strength
- Bond strength (tensile)
- Test of the seal integrity
- Verification of shelf life (aging of packaging in combination with functional testing)
- Transportation test
- Opening ability
- Materials in packaging
- Analysis of residues of ethylene oxide
Related standards
| Visuel integrity test of seals |
ASTM F 1886 |
| Measurement of seal width |
EN 868-5, Annex E |
| Tensile strength of seals |
ASTM F 88, SS-EN 868-5 |
| Integrity test, stain |
ASTM F 1929 |
| Burst test |
ASTM F 1140 |
| Accereated aging in heat/climate chamber |
ASTM F 1980 |
| Transportation test |
IEC 60068, ASTM D 4169 |