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
 

Test Standard
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

Related Information

Contact Persons

Linda Eriksson

Phone: +46 10 516 52 76

Catrin Lindblad

Phone: +46 10 516 53 14

SP Technical Research Institute of Sweden, Box 857, SE-501 15 Borås Phone +46 10-516 50 00, E-mail info@sp.se