Mammary Implants

Laboratory Testing of Breast Implants

MET is now providing breast implant testing to EN ISO 14607 - Non-active surgical implants - Mammary implants - Particular requirements.

Our test program includes:

Annex B:

  • Shell integrity testing for elongation
  • tensile set
  • tear resistance
  • strength of joints
  • seams and seals

Annex C:

Valve competence

Annex C:

Injection site competence

Annex D:

Silicone gel cohesion

Annex E:

Impact resistance

Annex E:

Static rupture resistance

Annex H: 

Silicone release assessment

Incubators are set up for long-term silicone release tests with sensitive analysis of the bathing fluid, in order to give confidence with regards to the long-term performance of the implants.

This is supported by our fatigue test rig, which can apply mechanical stress at 3.3Hz to nine implants at a time.