- 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
- Gel compression fracture testing
Gel compression fracture testing
For gel compression fracture testing, a universal testing machine with a 100 N load cell and a 15-mm-diameter compression stamp is used. The test setup also contains a flat bottom plate where the test sample is placed on. Gel compression fracture testing measures the strength of the implant to quantify forces it can withstand before permanent deformity. Compression is applied at 1 inch/min. Compression force applied against the gel is measured until a drop in force signifies the point of gel fracture. Greater compression force suggests increased resistance to gel fracture.
- 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