- 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
- ISO 14607:2018 Annex C.1 Fatigue Test*
ISO 14607:2018 Annex C.1 Fatigue Test*
ISO 14607:2018 describes in Annex C.1 the fatigue testing of breast implants under shear load. Thereby, the implant is placed between two horizontally arranged plates and a static load of 50 N per implant is applied. By means of an eccentric drive one of the plates is moved back and forth, whereby a shear load acts on the implant. The test is run for 6.5 million cycles at a frequency of 3.3 Hz. Subsequently, an optical rupture inspection is performed at 10x magnification.
We offer this test as a service and we can test six breast implants of different sizes in our test bench at the same time. We will be happy to provide a quotation.
*We offer this testing service as part of our accredited scope.
- 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