- 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 B Tests for shell integrity*
ISO 14607:2018 Annex B Tests for shell integrity*
As part of our breast implant testing portfolio, we offer the shell integrity tests according to ISO 14607: 2018 Annex B. These include tensile tests of the shell, measurement of elongation, and testing of seam strength.
For the abovementioned breast implant examinations, samples are first prepared using a standard punch. A corresponding punching knife according to ISO 37:2017 Type 2 is available at INNOPROOF so that we can obtain the samples from the breast implants at our premises. For applying tension to the specimen, we use our Zwick universal testing machine.
Please get in touch with us if you are interested in tests for mammary implant shell integrity.
*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