- Overview: Breast implants
- FDA Docket No. 2004D-0124 Fatigue test*
- ASTM F703 Gel Bleeding*
- ISO 14607:2018 Annex B Tests for shell integrity*
- ISO 14607:2018 Annex C.1 Fatigue Test*
- ISO 14607:2018 Annex C.2 Impaction Test*
- ISO 14607:2018 Annex D injection site competence*
- ISO 14607:2018 Annex E Cohesion Test*
- ISO 14607:2018 Annex H Surface characteristics*
- ISO 14607:2007 Static rupture strength
- Gel Material Property Testing
- Gel compression fracture testing
- Shell-gel peel testing
- Morphological analysis (Form Stability Testing)
INNOPROOF GmbH
- Joachim-Jungius-Straße 9
- 18059 D-Rostock
- +49 381 8011 3000
- +49 381 8011 3009
- info@innoproof.de
- Download Businesscard
- Start
- Services
- Breast implants
- Shell-gel peel testing
Shell-gel peel testing
For shell-gel peel testing, a universal testing machine with 100 N load cell and hydraulic grip is used. The test setup also contains a flat bottom plate where the test sample is placed on. For preparation, lines are drawn 1 inch apart on the shell of each test sample with a permanent marker, and a razor blade is used to cut along the lines drawn on the implant. The test sample is placed on the bottom plate in the testing machine, and 1 inch of the elastomer shell membrane is peeled away from the gel. The free end of the shell is clamped into the hydraulic grip of the testing machine and adjusted to uniformly distribute over the cross section of the specimen. The load is set to zero, and the elastomer shell is pulled at a rate of 20 inch/min. The maximum force applied to separate the shell from the gel is measured. The number of measurements per sample depends on the surface area of the sample, but should be minimum of two. The maximum force values obtained will be averaged.
- Overview: Breast implants
- FDA Docket No. 2004D-0124 Fatigue test*
- ASTM F703 Gel Bleeding*
- ISO 14607:2018 Annex B Tests for shell integrity*
- ISO 14607:2018 Annex C.1 Fatigue Test*
- ISO 14607:2018 Annex C.2 Impaction Test*
- ISO 14607:2018 Annex D injection site competence*
- ISO 14607:2018 Annex E Cohesion Test*
- ISO 14607:2018 Annex H Surface characteristics*
- ISO 14607:2007 Static rupture strength
- Gel Material Property Testing
- Gel compression fracture testing
- Shell-gel peel testing
- Morphological analysis (Form Stability Testing)
INNOPROOF GmbH
- Joachim-Jungius-Straße 9
- 18059 D-Rostock
- +49 381 8011 3000
- +49 381 8011 3009
- info@innoproof.de
- Download Businesscard