- 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.2 Impaction Test*
ISO 14607:2018 Annex C.2 Impaction Test*
For the impaction test according to ISO 14607:2018 Annex C.2, Innoproof developed and built its own drop tower, which ensures a standard-compliant test. Depending on the mass and projection height of the breast implant, the required height of the fall weight is calculated. The weight of 4.4 kg is held by an electromagnet and the drop height is set by means of a height indicator. The test specimen is placed centrally on the sample table. When the electromagnet is switched off, the drop weight is released and the impact is initiated. After the impaction test, the breast implant is subjected to an optical inspection in a digital microscope. For passing this test, the implant shell needs no be undamaged under inspection at 10x magnification.
*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